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    Clinical Trial Results:
    A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa.

    Summary
    EudraCT number
    2021-000214-42
    Trial protocol
    DE   FR   AT   GR   IT   ES  
    Global end of trial date
    19 Apr 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Apr 2024
    First version publication date
    13 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    755-201-EB
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04908215
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    InMed Pharmaceuticals Inc.
    Sponsor organisation address
    Suite 310 - 815 West Hastings Street, Vancouver, Canada, V6C 1B4
    Public contact
    Clinical Research Executive, InMed Pharmaceuticals Inc., 1 604-669-7207, clinical@inmedpharma.com
    Scientific contact
    Clinical Research Executive, InMed Pharmaceuticals Inc., 1 604-669-7207, clinical@inmedpharma.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
    19 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To evaluate the safety of INM-755 cream in patients with EB. - To obtain preliminary evidence of efficacy of INM-755 cream on wound and non-wound affected skin areas in patients with EB.
    Protection of trial subjects
    No special measures were required for this Phase 2 study of a topical cream product. If an important adverse reaction to the cream were to occur, it would simply be washed off and/or not re-applied in accordance with normal investigator oversight and patient preference.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Dec 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    France: 5
    Worldwide total number of subjects
    19
    EEA total number of subjects
    17
    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)
    3
    Adults (18-64 years)
    15
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment of patients for this very rare disease was undertaken in 6 EU countries (Austria, France, Germany, Greece, Italy, and Spain) and Israel. No patients were enrolled in Austria or Spain. The first patient was screened on 15Dec2021 in Israel and enrolled (first treatment) on 28Dec2021. The last patient was enrolled 10Mar2023.

    Pre-assignment
    Screening details
    Overall 27 subjects were screened: 4 subjects were screen failures immediately, 4 were SFs at the end of baseline observation week. A total of 19 patients were enrolled and received INM-755 cream and Vehicle cream. This study used a within-patient randomisation of pairs of matched index areas (1 area to INM-755 therapy and 1 area to Vehicle cream).

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Each patient could have a matched pair of non-wound index areas, wound index areas, or both. Each index area in a matched pair was randomised to INM-755 cream or Vehicle cream in a 1:1 ratio in a blinded manner. Study creams were identical in appearance and labelled in a blinded way. No study site personnel, patient, Sponsor personnel, or Sponsor designee who was involved in study conduct decisions was unblinded to treatment assignment throughout the duration of the study.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Non-Wound INM-755
    Arm description
    Non-wound index area within a matched pair assigned to INM-755 treatment
    Arm type
    Experimental

    Investigational medicinal product name
    INM-755 (cannabinol) Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use, Topical
    Dosage and administration details
    For non-wound index areas, the application of the study drug (either INM-755 cream or Vehicle cream) was done once daily, applied by the patient or caregiver directly on the index area skin in a typical thin layer (approximately 2 mg cream per cm2 of skin) and gently rubbed into the skin. Patients were given practical instructions on how to measure a suitable amount of cream using Fingertip Units calculated for the size of the area being treated. No dressing was required, but it was optional per the patient's preference. Treatment was to be given for a maximum of 28 days (Days 1 to 28).

    Arm title
    Non-Wound Vehicle
    Arm description
    Non-wound index area within a matched pair assigned to Vehicle control treatment
    Arm type
    vehicle control

    Investigational medicinal product name
    Vehicle Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use, Topical
    Dosage and administration details
    For non-wound index areas, the application of the study drug (either INM-755 cream or Vehicle cream) was done once daily, applied by the patient or caregiver directly on the index area skin in a typical thin layer (approximately 2 mg cream per cm2 of skin) and gently rubbed into the skin. Patients were given practical instructions on how to measure a suitable amount of cream using Fingertip Units calculated for the size of the area being treated. No dressing was required, but it was optional per the patient's preference. Treatment was to be given for a maximum of 28 days (Days 1 to 28).

    Number of subjects in period 1
    Non-Wound INM-755 Non-Wound Vehicle
    Started
    18
    18
    Week 1
    18
    18
    Week 2
    18
    18
    Week 3
    18
    18
    Week 4
    17
    17
    Completed
    17
    17
    Not completed
    1
    1
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    19 patients were enrolled and treated. Each patient had at least one pair of matched index areas treated with INM-755 and Vehicle in a randomized blinded manner. 17 patients had 1 pair of matched non-wound (NW) Index areas. 1 patient had 1 pair of matched wound (W) Index areas. 1 patient had both 1 pair of NW index areas and 1 pair of W index areas. N=18 patients for NW index areas, N=2 for W index areas.

    Reporting group values
    Treatment Period Total
    Number of subjects
    19 19
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    3 3
        Adults (18-64 years)
    15 15
        From 65-84 years
    1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    35.3 ± 15.39 -
    Gender categorical
    Units: Subjects
        Female
    11 11
        Male
    8 8
    Race
    Units: Subjects
        White
    19 19
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 0
        Not Hispanic or Latino
    16 16
        Unknown/Not Reported
    3 3
    Fitzpatrick Skin Type
    Skin Type scale based on skin colour and sensitivity to sun
    Units: Subjects
        Fitzpatrick Skin Type I
    2 2
        Fitzpatrick Skin Type II
    6 6
        Fitzpatrick Skin Type III
    10 10
        Fitzpatrick Skin Type IV
    1 1
        Fitzpatrick Skin Type V
    0 0
        Fitzpatrick Skin Type VI
    0 0
    Epidermolysis bullosa (EB) Type
    Genetic subtype of epidermolysis bullosa
    Units: Subjects
        EB Simplex
    4 4
        EB Junctional
    2 2
        EB Dominant Dystrophic
    2 2
        EB Recessive Dystrophic
    9 9
        EB Kindler
    2 2
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The SAF consisted of all index areas (non-wound or wound) that received INM-755 cream or matching Vehicle cream. The SAF was used for safety summaries and analysis of local effects. All patients who received the study drug were assessed for systemic effects. A total of 19 patients were enrolled and treated; 18 patients had non-wound index pairs and 2 patients had wound index pairs. One of the 19 patients had both non-wound and wound index pairs. Within each index pair, one skin area was randomized to INM-755 and one was randomized to Vehicle, in a blinded manner.

    Subject analysis set title
    Pharmacokinetic Analysis Set (PKS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The PKS included all patients who received at least one dose of the study drug and had at least one PK concentration measured. Provision of a single blood sample at the end of treatment for measurement of plasma cannabinol concentration was optional and 14 patients consented for that procedure.

    Subject analysis set title
    Non-wound Itch Evaluable Analysis Set (ESA)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All non-wound index areas meeting the eligibility criterion of non-wound itch ≥40 mm on Visual Analogue Scale (VAS, 0-100 mm) during the Baseline Observation Period (1 week before randomization and treatment initiation). *If a randomisation error was detected after database lock (once unblinding had occurred) then the SAF analysis set was to be used, in order to consider the effect of the actual treatment. This is what was done. It was an analysis "as treated".

    Subject analysis sets values
    Safety Analysis Set (SAF) Pharmacokinetic Analysis Set (PKS) Non-wound Itch Evaluable Analysis Set (ESA)
    Number of subjects
    19
    14
    14
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    3
    0
    2
        Adults (18-64 years)
    15
    13
    11
        From 65-84 years
    1
    1
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    11
    6
    9
        Male
    8
    8
    5
    Race
    Units: Subjects
        White
    19
    14
    14
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
    0
    0
        Not Hispanic or Latino
    16
    11
    13
        Unknown/Not Reported
    3
    3
    1
    Fitzpatrick Skin Type
    Skin Type scale based on skin colour and sensitivity to sun
    Units: Subjects
        Fitzpatrick Skin Type I
    2
    1
    2
        Fitzpatrick Skin Type II
    6
    5
    3
        Fitzpatrick Skin Type III
    10
    7
    8
        Fitzpatrick Skin Type IV
    1
    1
    1
        Fitzpatrick Skin Type V
    0
    0
    0
        Fitzpatrick Skin Type VI
    0
    0
    0
    Epidermolysis bullosa (EB) Type
    Genetic subtype of epidermolysis bullosa
    Units: Subjects
        EB Simplex
    4
    2
    3
        EB Junctional
    2
    2
    0
        EB Dominant Dystrophic
    2
    2
    2
        EB Recessive Dystrophic
    9
    6
    7
        EB Kindler
    2
    2
    2

    End points

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    End points reporting groups
    Reporting group title
    Non-Wound INM-755
    Reporting group description
    Non-wound index area within a matched pair assigned to INM-755 treatment

    Reporting group title
    Non-Wound Vehicle
    Reporting group description
    Non-wound index area within a matched pair assigned to Vehicle control treatment

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The SAF consisted of all index areas (non-wound or wound) that received INM-755 cream or matching Vehicle cream. The SAF was used for safety summaries and analysis of local effects. All patients who received the study drug were assessed for systemic effects. A total of 19 patients were enrolled and treated; 18 patients had non-wound index pairs and 2 patients had wound index pairs. One of the 19 patients had both non-wound and wound index pairs. Within each index pair, one skin area was randomized to INM-755 and one was randomized to Vehicle, in a blinded manner.

    Subject analysis set title
    Pharmacokinetic Analysis Set (PKS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The PKS included all patients who received at least one dose of the study drug and had at least one PK concentration measured. Provision of a single blood sample at the end of treatment for measurement of plasma cannabinol concentration was optional and 14 patients consented for that procedure.

    Subject analysis set title
    Non-wound Itch Evaluable Analysis Set (ESA)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All non-wound index areas meeting the eligibility criterion of non-wound itch ≥40 mm on Visual Analogue Scale (VAS, 0-100 mm) during the Baseline Observation Period (1 week before randomization and treatment initiation). *If a randomisation error was detected after database lock (once unblinding had occurred) then the SAF analysis set was to be used, in order to consider the effect of the actual treatment. This is what was done. It was an analysis "as treated".

    Primary: NW Itch: Within-patient difference in CFB (INM-755 - Vehicle)

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    End point title
    NW Itch: Within-patient difference in CFB (INM-755 - Vehicle)
    End point description
    Patients scored itch once daily for each non-wound (NW) index area within a matched pair (one area received INM-755, the other received Vehicle, as randomized and blinded). Itch was scored on the Visual Analogue Scale (0-100 mm), with 0 score meaning no itch and 100 score meaning the worst imaginable itch. Average weekly Itch scores were calculated for each index area and within-patient comparisons of INM-755 and Vehicle were tested using paired t-tests of the Change from Baseline (CFB). Note for interpretation: A negative value for within-patient difference in CFB (INM-755 - Vehicle) would favour INM-755.
    End point type
    Primary
    End point timeframe
    Weekly for 4 weeks
    End point values
    Non-Wound INM-755 Non-Wound Vehicle Non-wound Itch Evaluable Analysis Set (ESA)
    Number of subjects analysed
    14 [1]
    14 [2]
    14 [3]
    Units: mm
    arithmetic mean (standard deviation)
        Week 1
    -19.224 ± 27.2640
    -17.786 ± 18.9561
    -1.439 ± 15.8467
        Week 2
    -19.306 ± 27.3566
    -20.194 ± 24.9994
    0.888 ± 7.6389
        Week 3
    -23.19 ± 23.9680
    -23.614 ± 24.8766
    0.424 ± 15.6356
        Week 4
    -32.021 ± 26.6676
    -29.867 ± 26.8017
    -2.155 ± 14.3983
    Notes
    [1] - NW index areas excluded from ESA for 4 pts; 1 patient missing Week 4
    [2] - NW index areas excluded from ESA for 4 pts; 1 patient missing Week 4
    [3] - The within-patient difference in CFB for matched index areas (INM-755 - Vehicle). 1 missing Wk 4.
    Statistical analysis title
    NW Itch: Within-patient Paired t-test, Week 4
    Statistical analysis description
    Average weekly Itch scores were calculated for each index area and within-patient comparisons of INM-755 and Vehicle were tested using paired t-tests of the Change from Baseline (CFB). A negative value for within-patient difference in CFB (INM-755 - Vehicle) favours INM-755.
    Comparison groups
    Non-Wound INM-755 v Non-Wound Vehicle
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5994 [4]
    Method
    paired t-test
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.155
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.8554
         upper limit
    6.5462
    Variability estimate
    Standard deviation
    Dispersion value
    14.3983
    Notes
    [4] - p-values at earlier timepoints: Week 1 = 0.7395 Week 2 = 0.6708 Week 3 = 0.9206

    Secondary: PIC-I: Within-patient difference in CFB (INM-755 - Vehicle)

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    End point title
    PIC-I: Within-patient difference in CFB (INM-755 - Vehicle)
    End point description
    PIC-I = Patient's Impression of Change for Non-wound Itch. This was reported by the patient after 2 and 4 weeks of treatment for each of the matched index areas (one treated with INM-755, one with Vehicle). They scored their impression of change from baseline, using the Dynamic Pruritus Scale (+50 mm for maximal improvement (almost no itch remaining) to -50 mm (maximal worsening of itch), with 0 mm for no change. Note for interpretation: A positive result for within patient difference (PIC-I INM-755 minus PIC-I Vehicle) would indicate a better outcome on itch for INM-755 compared with Vehicle on the basis of PIC-I.
    End point type
    Secondary
    End point timeframe
    Week 2 and Week 4
    End point values
    Non-Wound INM-755 Non-Wound Vehicle Non-wound Itch Evaluable Analysis Set (ESA)
    Number of subjects analysed
    14 [5]
    14 [6]
    14 [7]
    Units: mm
    arithmetic mean (standard deviation)
        Week 2
    9.7 ± 24.85
    12.6 ± 29.22
    -2.9 ± 12.64
        Week 4
    10.0 ± 28.00
    7.5 ± 31.68
    2.5 ± 14.07
    Notes
    [5] - 4 pts excluded from ESA. Missing data for 1 pt at Week 2 (n=13). At Week 4 n=14.
    [6] - 4 pts excluded from ESA. Missing data for 1 pt at Week 2 (n=13). At Week 4 n=14.
    [7] - Missing data for 1 pt at Week 2 (n=13). At Week 4 n=14.
    Statistical analysis title
    PIC-I CFB: Within-patient Paired t-test, Week 4
    Comparison groups
    Non-Wound INM-755 v Non-Wound Vehicle
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5178 [8]
    Method
    paired t-test
    Parameter type
    Mean difference (final values)
    Point estimate
    2.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.62
         upper limit
    10.62
    Variability estimate
    Standard deviation
    Dispersion value
    14.07
    Notes
    [8] - p-value at Week 2 = 0.4206

    Other pre-specified: Plasma Cannabinol Concentration, End of Study

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    End point title
    Plasma Cannabinol Concentration, End of Study
    End point description
    It was optional for patients to provide a single blood sample for analysis at the end of treatment. 14 patients consented to this. Most samples were drawn within 0-2 days after last dose. For 3 patients, the samples were at 5, 7, and 19 days after last dose. Limit of quantitation was 1.0 pg/mL.
    End point type
    Other pre-specified
    End point timeframe
    Week 4 (End of Study)
    End point values
    Pharmacokinetic Analysis Set (PKS)
    Number of subjects analysed
    14
    Units: pg/mL
        median (full range (min-max))
    4.850 (0.00 to 176.00)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire treatment period: From first dose of study treatment until completion of therapy (max 4 weeks), and 1 week additional safety follow-up.
    Adverse event reporting additional description
    AEs were collected at weekly visits and recorded as local or systemic. Local AEs in index areas: treatment-emergent (TE) local AEs were summarised by treatment, severity, association with treatment or dressings. Other Local AEs (in untreated areas). Systemic AEs: TE systemic AEs were summarised by severity, association with treatment
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    INM-755 Treated Non-wound Index Areas, Local AEs
    Reporting group description
    This is the group of NW Index Areas treated with INM-755. Each patient with matched pairs of NW Index Areas received both treatments, one area treated with INM-755, the other with Vehicle (randomised, blinded).

    Reporting group title
    INM-755 Treated Wound Index Areas, Local AEs
    Reporting group description
    This is the group of Wound Index Areas treated with INM-755. Each patient with matched pairs of Wound Index Areas received both treatments, one area treated with INM-755, the other with Vehicle (randomised, blinded).

    Reporting group title
    Vehicle Treated Non-wound Index Areas, Local AEs
    Reporting group description
    This is the group of NW Index Areas treated with Vehicle. Each patient with matched pairs of NW Index Areas received both treatments, one area treated with INM-755, the other with Vehicle (randomised, blinded).

    Reporting group title
    Vehicle Treated Wound Index Areas, Local AEs
    Reporting group description
    This is the group of Wound Index Areas treated with Vehicle. Each patient with matched pairs of Wound Index Areas received both treatments, one area treated with INM-755, the other with Vehicle (randomised, blinded).

    Reporting group title
    Untreated Areas, Local AEs
    Reporting group description
    AEs were categorized as local or systemic. These local areas were not treated. The underlying disease (epidermolysis bullosa) is characterized by many skin lesions.

    Reporting group title
    All Treated Patients, Systemic AEs
    Reporting group description
    All patients received both INM-755 and Vehicle as topical treatments on matched index area pairs. These are the systemic AEs reported, not the AEs that occurred locally at the treated index areas or in other local untreated areas.

    Serious adverse events
    INM-755 Treated Non-wound Index Areas, Local AEs INM-755 Treated Wound Index Areas, Local AEs Vehicle Treated Non-wound Index Areas, Local AEs Vehicle Treated Wound Index Areas, Local AEs Untreated Areas, Local AEs All Treated Patients, Systemic AEs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Endocarditis
    Additional description: Endocarditis after 3 weeks of treatment, assessed as not related to masked study treatment. In the opinion of the Investigator, the event was due to the underlying medical condition of cardiomyopathy. Hospitalised, study treatment interrupted.
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    INM-755 Treated Non-wound Index Areas, Local AEs INM-755 Treated Wound Index Areas, Local AEs Vehicle Treated Non-wound Index Areas, Local AEs Vehicle Treated Wound Index Areas, Local AEs Untreated Areas, Local AEs All Treated Patients, Systemic AEs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 2 (0.00%)
    2 / 18 (11.11%)
    0 / 2 (0.00%)
    3 / 19 (15.79%)
    7 / 19 (36.84%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Eczema asteatotic
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Erythema
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Pseudofolliculitis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Skin ulcer
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Endocarditis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 2 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    0
    0
    1

    More information

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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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