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    Clinical Trial Results:
    Prospektive, dreiarmige, randomisierte Doppelblind-Studie gemäß MPG und AMG zur Wirksamkeit und Sicherheit der Behandlung der leichten bis moderaten aktinischen Keratose mit einer 5%-igen Kaliumhydroxidlösung (Solcera, Medizinprodukt) versus Placebo sowie untersucherverblindetem Vergleich mit Diclofenac 3% Gel (Solaraze, Arzneimittel)

    Summary
    EudraCT number
    		 2019-003678-16
    Trial protocol
    		 DE  
    Global end of trial date
    26 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Sep 2026
    First version publication date
    11 Sep 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KOHDIAK
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04552327
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Infectopharm Arzneimittel GmbH
    Sponsor organisation address
    Von-Humboldt-Str. 1, Heppenheim, Germany,
    Public contact
    Deputy Head of Clinical Research, Infectopharm Arzneimittel GmbH, +49 6252957000, Clinical.Trials@infectopharm.com
    Scientific contact
    Deputy Head of Clinical Research, Infectopharm Arzneimittel GmbH, +49 6252957000, Clinical.Trials@infectopharm.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primäres Zielkriterium ist der Therapieerfolg bei der Kontrollvisite nach Ende der Studienbehandlung des Patienten („EOT“ - End of treatment, je nach Remissionsverlauf nach Ende der off-Phase des 1., 2. oder 3. Behandlungszyklus für Solcera/Placebo bzw. Tag 60 für Solaraze).
    Protection of trial subjects
    In der Solaraze-Gruppe wird mit einem S3-Leitlinien-empfohlenen Arzneimittel behandelt, dessen Wirksamkeit und Sicherheit in kontrollierten klinischen Studien nachgewiesen wurde. Solaraze stellt das aktuell in Deutschland zur Behandlung der AK meistverordnete Präparat dar. Als Nebenwirkungen von Solaraze treten v.a. lokale Hautreaktionen auf, sodass die zu erwartende Wirksamkeit mögliche Risiken überwiegt. Solcera ist ein zur Behandlung der AK zertifiziertes Medizinprodukt, dessen Wirksamkeit auf Basis von Literaturdaten als mindestens so hoch wie die von Solaraze einzuschätzen ist. Die Verträglichkeit von Solcera hat sich in bisherigen Studien als gut und nicht Therapie-limitierend erwiesen. Nebenwirkungen können vor allem lokale (als Bestandteil des Wirkprinzips erwünschte) und vergleichsweise kurz anhaltende Hautreaktionen sein, die von den Patienten gut toleriert werden. Unter Placebo ist zwar nicht von einer direkten Wirksamkeit, andererseits kann es durch den natürlichen Verlauf der Erkrankung und begleitende Studienmaßnahmen (UV-Schutz, Vermeidung von intensiver Sonnenexposition und UV-Licht) im Zuge der Studienteilnahme aber auch in der Placebo-Gruppe zu einer Besserung der AK kommen. Vor dem Hintergrund, dass es sich bei der AK um eine chronische und nicht akut behandlungsbedürftige Erkrankung handelt und auch aktuell verfügbare Therapieoptionen keine nachhaltige Heilung ermöglichen, ist bei den hier einzuschließenden leichteren AK-Fällen eine Behandlung mit Placebo vertretbar, zumal jeder Patient engmaschig überwacht wird, sodass der Prüfarzt bei Bedarf Alternativbehandlungen der AK einleiten kann. Zudem erhalten alle Patienten bei Bedarf zum Zeitpunkt der Follow-up-Visite kostenlos eine Packung Solcera. Insofern ist hierdurch in allen Gruppen ein zusätzlicher direkter Individualnutzen gegeben.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 630
    Worldwide total number of subjects
    630
    EEA total number of subjects
    630
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    185
    From 65 to 84 years
    423
    85 years and over
    22

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Study participants are recruited from the pool of patients presenting with AK at the trial sites in accordance with the inclusion and exclusion criteria. All potentially eligible patients are recorded in a list, the so-called screening list, irrespective of whether they subsequently participate in the study.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Solcera
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solcera
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    Solcera® and Placebo were applied initially two times daily (morning/evening) in the affected area for four weeks. A small amount of solution was to be distributed on every lesion using the provided applicator, so that the entire lesion as well as the surrounding area 1 mm around the lesion was moistened. After that, the treatment was paused for four weeks and the remission was evaluated by the investigator. If the lesions, that were present at treatment start, did not show complete remission, the treatment was to be continued for another four weeks followed by a treatment-free interval of four weeks and reassessment by the investigator (2nd treatment cycle). If again no complete remission of the lesions present at treatment start was achieved, the treatment of the remaining lesions was to be continued for another four weeks followed by a treatment-free interval of four weeks and final reassessment by the investigator (3rd treatment cycle).

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    Solcera® and Placebo were applied initially two times daily (morning/evening) in the affected area for four weeks. A small amount of solution was to be distributed on every lesion using the provided applicator, so that the entire lesion as well as the surrounding area 1 mm around the lesion was moistened. After that, the treatment was paused for four weeks and the remission was evaluated by the investigator. If the lesions, that were present at treatment start, did not show complete remission, the treatment was to be continued for another four weeks followed by a treatment-free interval of four weeks and reassessment by the investigator (2nd treatment cycle). If again no complete remission of the lesions present at treatment start was achieved, the treatment of the remaining lesions was to be continued for another four weeks followed by a treatment-free interval of four weeks and final reassessment by the investigator (3rd treatment cycle).

    Arm title
    		 Solaraze
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Solaraze
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Solcera® and Placebo were applied initially two times daily (morning/evening) in the affected area for four weeks. A small amount of solution was to be distributed on every lesion using the provided applicator, so that the entire lesion as well as the surrounding area 1 mm around the lesion was moistened. After that, the treatment was paused for four weeks and the remission was evaluated by the investigator. If the lesions, that were present at treatment start, did not show complete remission, the treatment was to be continued for another four weeks followed by a treatment-free interval of four weeks and reassessment by the investigator (2nd treatment cycle). If again no complete remission of the lesions present at treatment start was achieved, the treatment of the remaining lesions was to be continued for another four weeks followed by a treatment-free interval of four weeks and final reassessment by the investigator (3rd treatment cycle).

    Number of subjects in period 1
    		Solcera Placebo Solaraze
    Started
    204
    212
    214
    Completed
    204
    212
    214
    Period 2
    Period 2 title
    Post-baseline visits
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Solcera
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solcera
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    Solcera® and Placebo were applied initially two times daily (morning/evening) in the affected area for four weeks. A small amount of solution was to be distributed on every lesion using the provided applicator, so that the entire lesion as well as the surrounding area 1 mm around the lesion was moistened. After that, the treatment was paused for four weeks and the remission was evaluated by the investigator. If the lesions, that were present at treatment start, did not show complete remission, the treatment was to be continued for another four weeks followed by a treatment-free interval of four weeks and reassessment by the investigator (2nd treatment cycle). If again no complete remission of the lesions present at treatment start was achieved, the treatment of the remaining lesions was to be continued for another four weeks followed by a treatment-free interval of four weeks and final reassessment by the investigator (3rd treatment cycle).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    Solcera® and Placebo were applied initially two times daily (morning/evening) in the affected area for four weeks. A small amount of solution was to be distributed on every lesion using the provided applicator, so that the entire lesion as well as the surrounding area 1 mm around the lesion was moistened. After that, the treatment was paused for four weeks and the remission was evaluated by the investigator. If the lesions, that were present at treatment start, did not show complete remission, the treatment was to be continued for another four weeks followed by a treatment-free interval of four weeks and reassessment by the investigator (2nd treatment cycle). If again no complete remission of the lesions present at treatment start was achieved, the treatment of the remaining lesions was to be continued for another four weeks followed by a treatment-free interval of four weeks and final reassessment by the investigator (3rd treatment cycle).

    Investigational medicinal product name
    Solaraze
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Solcera® and Placebo were applied initially two times daily (morning/evening) in the affected area for four weeks. A small amount of solution was to be distributed on every lesion using the provided applicator, so that the entire lesion as well as the surrounding area 1 mm around the lesion was moistened. After that, the treatment was paused for four weeks and the remission was evaluated by the investigator. If the lesions, that were present at treatment start, did not show complete remission, the treatment was to be continued for another four weeks followed by a treatment-free interval of four weeks and reassessment by the investigator (2nd treatment cycle). If again no complete remission of the lesions present at treatment start was achieved, the treatment of the remaining lesions was to be continued for another four weeks followed by a treatment-free interval of four weeks and final reassessment by the investigator (3rd treatment cycle).

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    Solcera® and Placebo were applied initially two times daily (morning/evening) in the affected area for four weeks. A small amount of solution was to be distributed on every lesion using the provided applicator, so that the entire lesion as well as the surrounding area 1 mm around the lesion was moistened. After that, the treatment was paused for four weeks and the remission was evaluated by the investigator. If the lesions, that were present at treatment start, did not show complete remission, the treatment was to be continued for another four weeks followed by a treatment-free interval of four weeks and reassessment by the investigator (2nd treatment cycle). If again no complete remission of the lesions present at treatment start was achieved, the treatment of the remaining lesions was to be continued for another four weeks followed by a treatment-free interval of four weeks and final reassessment by the investigator (3rd treatment cycle).

    Arm title
    		 Solaraze
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Solaraze
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Solcera® and Placebo were applied initially two times daily (morning/evening) in the affected area for four weeks. A small amount of solution was to be distributed on every lesion using the provided applicator, so that the entire lesion as well as the surrounding area 1 mm around the lesion was moistened. After that, the treatment was paused for four weeks and the remission was evaluated by the investigator. If the lesions, that were present at treatment start, did not show complete remission, the treatment was to be continued for another four weeks followed by a treatment-free interval of four weeks and reassessment by the investigator (2nd treatment cycle). If again no complete remission of the lesions present at treatment start was achieved, the treatment of the remaining lesions was to be continued for another four weeks followed by a treatment-free interval of four weeks and final reassessment by the investigator (3rd treatment cycle).

    Number of subjects in period 2
    		Solcera Placebo Solaraze
    Started
    204
    212
    214
    Completed
    185
    194
    198
    Not completed
    19
    18
    16
         Consent withdrawn by subject
    4
    8
    4
         Intolerability reaction
    3
    2
    4
         Adverse event
    4
    3
    4
         Other reason
    6
    1
    2
         Treatment interruption
    1
    -
    -
         Lack of efficacy
    1
    4
    1
         SARS-CoV-2
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 630 630
    Age categorical
    Age (years)
    Units: Subjects
        Adults
    		 630 630
    Age continuous
    Age (years)
    Units: years
        arithmetic mean (standard deviation)
    		 69.8 ( 9.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 189 189
        Male
    		 441 441

    End points

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    End points reporting groups
    Reporting group title
    Solcera
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Solaraze
    Reporting group description
    		 -
    Reporting group title
    Solcera
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Solaraze
    Reporting group description
    		 -

    Primary: Treatment Success (FA)

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    End point title
    		 Treatment Success (FA)
    End point description
    Treatment success, defined as complete, dermatoscopically confirmed remission of all initial actinic keratosis (AK) lesions identified at treatment start that have been treated with the investigational product („Complete Clearance“) Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Primary
    End point timeframe
    At the control visit at the end of treatment ("EOT", i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60)
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: participants
    90
    47
    50
    Statistical analysis title
    		 Superiority Solcera/Placebo
    Comparison groups
    Solcera v Placebo v Solaraze
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Superiority Solcera/Solaraze
    Comparison groups
    Solcera v Placebo v Solaraze
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Confidence interval

    Primary: Treatment Success (PP)

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    End point title
    		 Treatment Success (PP)
    End point description
    Treatment success, defined as complete, dermatoscopically confirmed remission of all initial actinic keratosis (AK) lesions identified at treatment start that have been treated with the investigational product („Complete Clearance“) Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Primary
    End point timeframe
    At the control visit at the end of treatment („EOT“, i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60)
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    167
    183
    180
    Units: participants
    76
    44
    37
    Statistical analysis title
    		 Non-inferiority of Solcera to Solaraze
    Comparison groups
    Solcera v Placebo v Solaraze
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.31
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.497

    Secondary: Treatment Success (FA)

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    End point title
    		 Treatment Success (FA)
    End point description
    Treatment success, defined as complete, dermatoscopically confirmed remission of all initial AK lesions identified at treatment start that have been treated with the investigational product („Complete Clearance“) Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    For Solaraze at day 90, for Solcera/Placebo at EOT
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: participants
    90
    47
    82
    No statistical analyses for this end point

    Secondary: (Healing) status of inital AK lesions

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    End point title
    		 (Healing) status of inital AK lesions
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At end of treatment (EOT)
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Lesions
    number (not applicable)
        Proliferating
    25
    45
    23
        Unchanged/stable
    56
    153
    84
        In remission/partial remisson
    108
    152
    224
        Complete remission
    408
    254
    302
        Relapse
    31
    33
    25
        Size 0-5 mm
    524
    438
    494
        Size 6-10 mm
    83
    163
    139
        Size 11-15 mm
    15
    34
    23
        Size 16-20 mm
    6
    2
    2
    No statistical analyses for this end point

    Secondary: Overall number of AK lesions

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    End point title
    		 Overall number of AK lesions
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: participants
        0 Lesions
    95
    49
    52
        1 Lesions
    43
    48
    68
        2 Lesions
    26
    40
    28
        3 Lesions
    23
    33
    26
        4 Lesions
    4
    19
    26
        5 Lesions
    8
    16
    10
    No statistical analyses for this end point

    Secondary: Mean Size of AK Lesions

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    End point title
    		 Mean Size of AK Lesions
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At OT
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: mm
        arithmetic mean (standard deviation)
    2.0 ( 3.1 )
    3.8 ( 3.3 )
    3.4 ( 3.2 )
    No statistical analyses for this end point

    Secondary: Treatment Success

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    End point title
    		 Treatment Success
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT
    End point values
    		 Solcera Placebo
    Number of subjects analysed
    199
    205
    Units: participants
        Visit 8 weeks
    31
    12
        Visit 16 weeks
    58
    29
        Visit 24 weeks
    90
    47
    No statistical analyses for this end point

    Secondary: Treatment Success

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    End point title
    		 Treatment Success
    End point description
    At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
    End point type
    Secondary
    End point timeframe
    Day 30, Day 60, Day 90,
    End point values
    		 Solaraze
    Number of subjects analysed
    210
    Units: participants
        Visit 30 days
    19
        Visit 60 days
    50
        Visit 90 days
    82
    No statistical analyses for this end point

    Secondary: Treatment Success

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    End point title
    		 Treatment Success
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT an Follow-up 24 weeks
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: participants
        EOT
    90
    47
    50
        Follow-up 24 weeks
    74
    43
    86
    No statistical analyses for this end point

    Secondary: Partial Clearance

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    End point title
    		 Partial Clearance
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: participants
    108
    57
    67
    No statistical analyses for this end point

    Secondary: Reduction of AK lesions number

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    End point title
    		 Reduction of AK lesions number
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: percentage
        arithmetic mean (standard deviation)
    65.6 ( 38.7 )
    38.3 ( 41.1 )
    43.8 ( 40.8 )
    No statistical analyses for this end point

    Secondary: Clinical Response

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    End point title
    		 Clinical Response
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: participants
    161
    110
    129
    No statistical analyses for this end point

    Secondary: Lesions-based Treatment Success (without consideration of relapses)

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    End point title
    		 Lesions-based Treatment Success (without consideration of relapses)
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Lesions
        number (not applicable)
    439
    287
    327
    No statistical analyses for this end point

    Secondary: Lesion-based Treatment Success (with consideration of relapses)

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    End point title
    		 Lesion-based Treatment Success (with consideration of relapses)
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    tbd
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Lesions
        number (not applicable)
    408
    254
    302
    No statistical analyses for this end point

    Secondary: Patients with relapse

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    End point title
    		 Patients with relapse
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At Follow-up
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: participants
    16
    4
    21
    No statistical analyses for this end point

    Secondary: Lesions with relapse

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    End point title
    		 Lesions with relapse
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Lesions
        number (not applicable)
    21
    7
    66
    No statistical analyses for this end point

    Secondary: Efficacy assessment by physician

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    End point title
    		 Efficacy assessment by physician
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Participants
        very good
    79
    42
    60
        good
    55
    49
    80
        satisfactory
    28
    36
    36
        sufficient
    15
    17
    11
        poor
    7
    19
    12
        insufficient
    6
    36
    2
        missing
    9
    6
    9
    No statistical analyses for this end point

    Secondary: Efficacy Assessment by Patient

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    End point title
    		 Efficacy Assessment by Patient
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Participant
        very good
    77
    35
    56
        good
    54
    56
    85
        satisfactory
    34
    41
    39
        sufficient
    14
    18
    11
        poor
    9
    16
    7
        insufficient
    2
    33
    3
        missing
    9
    6
    9
    No statistical analyses for this end point

    Secondary: Tolerability assessment by physician

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    End point title
    		 Tolerability assessment by physician
    End point description
    Safety-evaluable data set (all randomised patients who received the study medication and for whom an application of the study medication at least cannot be ruled out)
    End point type
    Secondary
    End point timeframe
    At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Participants
        very good
    95
    118
    116
        good
    75
    65
    60
        satisfactory
    16
    10
    19
        sufficient
    1
    3
    5
        poor
    2
    2
    4
        insufficient
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Tolerability assessment by patient

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    End point title
    		 Tolerability assessment by patient
    End point description
    Safety-evaluable data set (all randomised patients who received the study medication and for whom an application of the study medication at least cannot be ruled out)
    End point type
    Secondary
    End point timeframe
    At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    190
    199
    205
    Units: Participants
        very good
    74
    119
    108
        good
    90
    58
    64
        satisfactory
    19
    16
    17
        sufficient
    3
    4
    8
        poor
    2
    0
    4
        in sufficient
    2
    2
    4
    No statistical analyses for this end point

    Secondary: Overall assessment by physician

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    End point title
    		 Overall assessment by physician
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Participants
        very good
    75
    40
    55
        good
    65
    58
    92
        satisfactory
    28
    39
    35
        sufficient
    9
    20
    14
        poor
    9
    28
    4
        insufficient
    2
    14
    1
        missing
    11
    6
    9
    No statistical analyses for this end point

    Secondary: Overall assessment by patient

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    End point title
    		 Overall assessment by patient
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Participants
        very good
    69
    38
    57
        good
    74
    64
    96
        satisfactory
    28
    37
    33
        sufficient
    9
    26
    9
        poor
    7
    29
    5
        insufficient
    1
    5
    1
        missing
    11
    6
    9
    No statistical analyses for this end point

    Secondary: Adverse Events, Serious Adverse Events, Adverse Reactions

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    End point title
    		 Adverse Events, Serious Adverse Events, Adverse Reactions
    End point description
    Safety-evaluable data set (all randomised patients who received the study medication and for whom an application of the study medication at least cannot be ruled out)
    End point type
    Secondary
    End point timeframe
    In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    204
    212
    214
    Units: Treatment-emergent Events
    number (not applicable)
        Treatmet-emergent Adverse Events (TEAE)
    293
    123
    177
        Treatment-emergent Serious Adverse Events
    21
    16
    13
        Treatment-emergent Adverse Drug Reaction
    206
    34
    106
    No statistical analyses for this end point

    Secondary: Dropouts

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    End point title
    		 Dropouts
    End point description
    Safety-evaluable data set (all randomised patients who received the study medication and for whom an application of the study medication at least cannot be ruled out)
    End point type
    Secondary
    End point timeframe
    In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    204
    212
    214
    Units: Participants
        Informed consent withdrawn
    4
    8
    4
        Adverse event
    4
    3
    4
        Interruption treatment >10 consecutive application
    1
    0
    0
        Intolerability reaction
    3
    2
    4
        Lack of efficacy
    1
    4
    1
        Discontinuation due to SARS-CoV-2
    0
    0
    1
        Other reasons
    6
    1
    2
    No statistical analyses for this end point

    Secondary: Compliance

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    End point title
    		 Compliance
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    Analysed for the respective time period of scheduled product application, i.e. Day 0 until Day 60 for Solaraze and 1-3x 28 days (depeding on number of cycles) for Solcera/Placebo
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    199
    205
    210
    Units: Percentage of comliance
        arithmetic mean (standard deviation)
    101.1 ( 16.8 )
    98.4 ( 11.5 )
    94.8 ( 12.6 )
    No statistical analyses for this end point

    Secondary: Treatment success (PP)

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    End point title
    		 Treatment success (PP)
    End point description
    Full-analysis data set (at least one IMP application, at least one post-baseline value for the primary endpoint; plus “Baseline-Observation-Carried-Forward” [BOCF] of primary efficacy variable for all patients who (i) withdrew due to lacking tolerability and applied the study medication at least once or (ii) withdrew due to lacking efficacy (e.g. also other AK therapies of the lesions used in the initially treated area) and applied the study medication for at least 7 days
    End point type
    Secondary
    End point timeframe
    For Solaraze at day 90, for Solcera/Placebo at EOT
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    167
    183
    180
    Units: Participants
    76
    44
    63
    No statistical analyses for this end point

    Secondary: Adverse Events, Serious Adverse Events, Adverse Reactions

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    End point title
    		 Adverse Events, Serious Adverse Events, Adverse Reactions
    End point description
    Safety-evaluable data set (all randomised patients who received the study medication and for whom an application of the study medication at least cannot be ruled out)
    End point type
    Secondary
    End point timeframe
    In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
    End point values
    		 Solcera Placebo Solaraze
    Number of subjects analysed
    204
    212
    214
    Units: Prticipants
        with treatment-emergent Adverse Event (TEAE)
    113
    78
    92
        with treatment-emergent Serious Adverse Event
    17
    12
    11
        with treatment-emergent Serious Drug Reaction (ADR
    78
    23
    47
        with ADR not part of expected/desired reaction
    6
    4
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Adverse event reporting additional description
    For non-serious adverse events please see respective endpoints
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Solcera
    Reporting group description
    		 In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)

    Reporting group title
    Placebo
    Reporting group description
    		 In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)

    Reporting group title
    Solaraze
    Reporting group description
    		 In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)

    Serious adverse events
    		 Solcera Placebo Solaraze
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 204 (8.33%)
    12 / 212 (5.66%)
    11 / 214 (5.14%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    9 / 204 (4.41%)
    6 / 212 (2.83%)
    4 / 214 (1.87%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    2 / 204 (0.98%)
    1 / 212 (0.47%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    2 / 204 (0.98%)
    0 / 212 (0.00%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 212 (0.47%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Vascular stenosis
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 212 (0.00%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 212 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 212 (0.00%)
    2 / 214 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 212 (0.00%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 212 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 212 (0.47%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Somatic symptom disorder
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 212 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 212 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 212 (0.47%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Skeletal dysplasia
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 212 (0.47%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    2 / 204 (0.98%)
    0 / 212 (0.00%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Rheumatic heart disease
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 212 (0.47%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Visual impairment
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 212 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 212 (0.47%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    0 / 212 (0.00%)
    1 / 214 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    1 / 204 (0.49%)
    1 / 212 (0.47%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hypertrophic scar
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 212 (0.00%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 212 (0.00%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Influenza
    Additional description: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 212 (0.47%)
    0 / 214 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Solcera Placebo Solaraze
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 204 (42.16%)
    47 / 212 (22.17%)
    58 / 214 (27.10%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 204 (0.49%)
    1 / 212 (0.47%)
    1 / 214 (0.47%)
         occurrences all number
    1
    1
    1
    Seborrhoeic keratosis
         subjects affected / exposed
    4 / 204 (1.96%)
    2 / 212 (0.94%)
    5 / 214 (2.34%)
         occurrences all number
    4
    2
    5
    Injury, poisoning and procedural complications
    not appicable
         subjects affected / exposed
    3 / 204 (1.47%)
    4 / 212 (1.89%)
    6 / 214 (2.80%)
         occurrences all number
    3
    4
    6
    Vascular disorders
    not applicable
         subjects affected / exposed
    5 / 204 (2.45%)
    4 / 212 (1.89%)
    2 / 214 (0.93%)
         occurrences all number
    5
    4
    2
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    53 / 204 (25.98%)
    10 / 212 (4.72%)
    29 / 214 (13.55%)
         occurrences all number
    65
    10
    29
    Application site pain
         subjects affected / exposed
    45 / 204 (22.06%)
    8 / 212 (3.77%)
    7 / 214 (3.27%)
         occurrences all number
    66
    8
    7
    Application site scab
         subjects affected / exposed
    29 / 204 (14.22%)
    3 / 212 (1.42%)
    21 / 214 (9.81%)
         occurrences all number
    39
    3
    22
    Application site pruritus
         subjects affected / exposed
    5 / 204 (2.45%)
    5 / 212 (2.36%)
    18 / 214 (8.41%)
         occurrences all number
    5
    5
    18
    Application site exfoliation
         subjects affected / exposed
    10 / 204 (4.90%)
    3 / 212 (1.42%)
    14 / 214 (6.54%)
         occurrences all number
    13
    3
    14
    Application site erosion
         subjects affected / exposed
    5 / 204 (2.45%)
    0 / 212 (0.00%)
    2 / 214 (0.93%)
         occurrences all number
    6
    0
    2
    Eye disorders
    not applicable
         subjects affected / exposed
    1 / 204 (0.49%)
    5 / 212 (2.36%)
    2 / 214 (0.93%)
         occurrences all number
    1
    5
    3
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    4 / 204 (1.96%)
    2 / 212 (0.94%)
    1 / 214 (0.47%)
         occurrences all number
    4
    2
    1
    Musculoskeletal and connective tissue disorders
    not applicable
         subjects affected / exposed
    8 / 204 (3.92%)
    3 / 212 (1.42%)
    1 / 214 (0.47%)
         occurrences all number
    8
    3
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 204 (1.96%)
    10 / 212 (4.72%)
    2 / 214 (0.93%)
         occurrences all number
    4
    10
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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