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    Clinical Trial Results:
    Clinical Trial Exit Interview Study in Cutaneous T-cell Lymphoma (CTCL) to Capture Meaningful Treatment Benefit from a Patient’s Perspective

    Summary
    EudraCT number
    		 2020-001992-34
    Trial protocol
    		 DE  
    Global end of trial date
    16 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Nov 2022
    First version publication date
    01 Nov 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EVM-22656
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma R&D SNC
    Sponsor organisation address
    Les Templiers, 2400 route des Colles, Biot, France, 06410
    Public contact
    CTA Coordinator, Galderma R&D SNC, +33 493-95-70-85, cta.coordinator@galderma.com
    Scientific contact
    CTA Coordinator, Galderma R&D SNC, +33 493-95-70-85, cta.coordinator@galderma.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
    31 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to characterize subjects experienced treatment benefit of CD11301 gel: a. Provide a subject-focused assessment of disease burden. b. Capture subjects experience of the study treatment (what are the perceived benefits and risks of treatment, changes in subjects daily life since baseline, unexpected treatment effects, subjects treatment expectations, satisfaction and comparison to previous treatments). c. Explore subjects perceptions of meaningful change from baseline (i.e., what constitutes a meaningful treatment effect, which aspects are most relevant and most meaningful to subjects).
    Protection of trial subjects
    This study was performed in compliance with Good Clinical Practice (GCP) including the archiving of essential study documents. All data provided either to the Investigator (and study staff) or collected during the study and/or reported herein should be regarded as confidential and proprietary in nature and should not be disclosed to any third party without the written consent of Galderma.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2019
    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: 5
    Country: Number of subjects enrolled
    United States: 14
    Worldwide total number of subjects
    19
    EEA total number of subjects
    5
    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)
    14
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 3 clinical sites (one in Germany and two in United States) from 30 April 2019 to 16 April 2021.

    Pre-assignment
    Screening details
    		 A total of 19 subjects who met predefined inclusion/exclusion criteria, expressed an interest in participating in the interview study, and provided consent were enrolled.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]
    Blinding implementation details
    Interviewers i.e., clinicians who met eligibility criteria were blinded to the treatment assignment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CTCL Stage IA
    Arm description
    		 Subjects who had early stage disease (CTCL stage IA) were treated with placebo and resiquimod gel (0.03 percent (%) or 0.06%) for eight weeks during cycle 1 followed by resiquimod gel (0.03% or 0.06%) for eight weeks during cycle 2. Subjects who treated with placebo in cycle 1 received resiquimod gel 0.03% during Cycle 2. The two treatment cycles were having duration of 12 weeks of each (eight weeks of treatment plus four weeks of treatment-free) were followed by a 12 weeks treatment-free follow-up period. Those eligible trial subjects were interviewed after completion of either of the treatment cycle for 3 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Subjects were applied placebo gel topically in cycle 1.

    Investigational medicinal product name
    Resiquimod gel (CD11301 gel) 0.03 percent (%) or 0.06%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Subjects were treated with resiquimod gel (CD11301 gel) 0.03 percent (%) or 0.06% topically between 2 treatment cycles.

    Arm title
    		 CTCL Stage IB
    Arm description
    		 Subjects who had early CTCL stage disease (CTCL stage IB) were treated with placebo and resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 1 followed by resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 2. Subjects who treated with placebo in Cycle 1 received resiquimod gel 0.03% during Cycle 2. The two treatment cycles were having duration of 12 weeks of each (eight weeks of treatment plus four weeks of treatment-free) were followed by a 12 week treatment-free follow-up period. Those eligible trial participants were interviewed after completion of either of the treatment cycle for 3 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Resiquimod (0.03% or 0.06% gel)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Subjects were treated topically with resiquimod gel (CD11301 gel) 0.03 percent (%) or 0.06% topically between 2 treatment cycles.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Subjects were treated with placebo gel topically in cycle 1.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Eligible Interviewers i.e., clinical investigators who conducted interviews of the subjects were blinded to the treatment assignment.
    Number of subjects in period 1
    		CTCL Stage IA CTCL Stage IB
    Started
    11
    8
    Completed
    10
    7
    Not completed
    1
    1
         Early discontinuer
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CTCL Stage IA
    Reporting group description
    		 Subjects who had early stage disease (CTCL stage IA) were treated with placebo and resiquimod gel (0.03 percent (%) or 0.06%) for eight weeks during cycle 1 followed by resiquimod gel (0.03% or 0.06%) for eight weeks during cycle 2. Subjects who treated with placebo in cycle 1 received resiquimod gel 0.03% during Cycle 2. The two treatment cycles were having duration of 12 weeks of each (eight weeks of treatment plus four weeks of treatment-free) were followed by a 12 weeks treatment-free follow-up period. Those eligible trial subjects were interviewed after completion of either of the treatment cycle for 3 weeks.

    Reporting group title
    CTCL Stage IB
    Reporting group description
    		 Subjects who had early CTCL stage disease (CTCL stage IB) were treated with placebo and resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 1 followed by resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 2. Subjects who treated with placebo in Cycle 1 received resiquimod gel 0.03% during Cycle 2. The two treatment cycles were having duration of 12 weeks of each (eight weeks of treatment plus four weeks of treatment-free) were followed by a 12 week treatment-free follow-up period. Those eligible trial participants were interviewed after completion of either of the treatment cycle for 3 weeks.

    Reporting group values
    		 CTCL Stage IA CTCL Stage IB Total
    Number of subjects
    		 11 8 19
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.4 ± 12 55.1 ± 18.1 -
    Gender categorical
    Units: Subjects
        Female
    		 0 3 3
        Male
    		 11 5 16
    Race
    Units: Subjects
        White
    		 9 6 15
        Black
    		 0 2 2
        Asian
    		 1 0 1
        Other
    		 1 0 1
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 9 8 17
        Hispanic or Latino
    		 2 0 2
    CountryUS
    Units: Subjects
        US
    		 9 5 14
        Germany
    		 2 3 5

    End points

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    End points reporting groups
    Reporting group title
    CTCL Stage IA
    Reporting group description
    		 Subjects who had early stage disease (CTCL stage IA) were treated with placebo and resiquimod gel (0.03 percent (%) or 0.06%) for eight weeks during cycle 1 followed by resiquimod gel (0.03% or 0.06%) for eight weeks during cycle 2. Subjects who treated with placebo in cycle 1 received resiquimod gel 0.03% during Cycle 2. The two treatment cycles were having duration of 12 weeks of each (eight weeks of treatment plus four weeks of treatment-free) were followed by a 12 weeks treatment-free follow-up period. Those eligible trial subjects were interviewed after completion of either of the treatment cycle for 3 weeks.

    Reporting group title
    CTCL Stage IB
    Reporting group description
    		 Subjects who had early CTCL stage disease (CTCL stage IB) were treated with placebo and resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 1 followed by resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 2. Subjects who treated with placebo in Cycle 1 received resiquimod gel 0.03% during Cycle 2. The two treatment cycles were having duration of 12 weeks of each (eight weeks of treatment plus four weeks of treatment-free) were followed by a 12 week treatment-free follow-up period. Those eligible trial participants were interviewed after completion of either of the treatment cycle for 3 weeks.

    Subject analysis set title
    Total Number Of Subjects in Exit Interview Sample Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Total Number Of Subjects in Exit Interview Sample Study

    Primary: Number of Subjects Who Described Their CTCL Diagnosis Experience of Early CTCL Stage

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    End point title
    		 Number of Subjects Who Described Their CTCL Diagnosis Experience of Early CTCL Stage [1]
    End point description
    The subject interview guide was used to explore their CTCL diagnosis experience (burned or itchy lesions, enquired doctor about their skin condition, misdiagnosed or treated for other diseases) of early CTCL stage. Subjects who described their CTCL diagnosis experience of early CTCL stage before entering in the qualitative interview study were reported in this endpoint.
    End point type
    Primary
    End point timeframe
    At Baseline
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
        Burned or Itchy Lesions
    5
        Enquired Doctor About Their Skin Condition
    4
        Misdiagnosed or treated for other diseases
    15
    No statistical analyses for this end point

    Primary: Number of Subjects Who Reported Treatment Experience Prior to Clinical Trial

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    End point title
    		 Number of Subjects Who Reported Treatment Experience Prior to Clinical Trial [2]
    End point description
    The subjects who reported treatment experience prior to clinical trial were evaluated with the use of subject interview guide. Subjects who received treatments (corticosteroids, chemotherapy, retinoid, over-the-counter medication, moisturizers/cream/shampoo, light therapy, oral medication, radiation, other investigational treatments, injection, holistic, antibiotic) before entering in the qualitative interview study were reported for this endpoint.
    End point type
    Primary
    End point timeframe
    At Baseline
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    Units: subjects
        Corticosteroids
    12
        Chemotherapy
    4
        Retinoid
    2
        Over-the-counter Moisturizers/Cream/Shampoo
    4
        Light Therapy
    10
        Oral Medication
    5
        Radiation
    4
        Other Investigational Treatments
    2
        Injection
    1
        Holistic
    1
        Antibiotic
    1
    No statistical analyses for this end point

    Primary: Number of Subjects Experienced Symptoms of Early CTCL Stage

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    End point title
    		 Number of Subjects Experienced Symptoms of Early CTCL Stage [3]
    End point description
    The subjects experience of early CTCL stage symptoms were evaluated with the use of subject interview guide. The number of subjects who described the CTCL-related symptoms (redness, dryness, itch, skin patches, blotchiness, skin sensitivity, discomfort or pain, skin plaques, bleeding, burning, skin lesions, lack of energy or fatigue, hair loss or change in hair growth) they have experienced before entering in the qualitative interview study were reported in this endpoint.
    End point type
    Primary
    End point timeframe
    At Baseline
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
        Redness
    17
        Dryness
    16
        Itch
    14
        Skin patches
    14
        Blotchiness
    11
        Skin sensitivity
    11
        Discomfort or pain
    10
        Skin plaques
    9
        Bleeding
    8
        Burning
    8
        Skin lesions
    8
        Lack of energy or fatigue
    6
        Hair loss or change in hair growth
    4
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced The Daily Routine Impact of Early CTCL Stage

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    End point title
    		 Number of Subjects Who Experienced The Daily Routine Impact of Early CTCL Stage [4]
    End point description
    The subjects experience of prior treatment were evaluated with the use of subject interview guide. The number of subjects who experienced the daily routine impact (altered clothing choices, work, social/leisure activities, chores/housework, avoiding sun/sun protection, exercise, wearing gauze/ bandage) before entering in the qualitative interview study were reported in this endpoint.
    End point type
    Primary
    End point timeframe
    At Baseline
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
        Altered Clothing Choices
    7
        Work
    6
        Social/Leisure Activities
    5
        Chores/Housework
    4
        Avoiding sun/sun protection
    3
        Exercise
    2
        Wearing gauze/ bandage
    1
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Emotional Impact of Early CTCL Stage

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    End point title
    		 Number of Subjects Who Experienced Emotional Impact of Early CTCL Stage [5]
    End point description
    The subjects experience of CTCL emotional impact were evaluated with the use of subject interview guide. The number of subjects who experienced of emotional impact (embarrassment/uncomfortable, worry/anxiety/nervousness, stress and frustration, depression, self-identity) before entering in the qualitative interview study were reported in this endpoint.
    End point type
    Primary
    End point timeframe
    At Baseline
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
        Embarrassment/Uncomfortable
    9
        Worry/Anxiety/Nervousness
    5
        Stress and Frustration
    3
        Depression
    2
        Self-identity
    2
    No statistical analyses for this end point

    Primary: Number of Subjects With Sleep Disruption, Financial Burden, Relationship Impact Experience of Early CTCL Stage

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    End point title
    		 Number of Subjects With Sleep Disruption, Financial Burden, Relationship Impact Experience of Early CTCL Stage [6]
    End point description
    The subjects who experienced CTCL related impacts (sleep Disruption, financial burden, relationship) were reported with the use of subject interview guide. The number of subjects who experienced sleep Disruption, financial burden, relationship impacts before entering in the qualitative interview study were reported in this endpoint.
    End point type
    Primary
    End point timeframe
    At Baseline
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
        Sleep disruption
    8
        Financial burden
    7
        Relationship
    6
    No statistical analyses for this end point

    Primary: Number of Subjects With Reasons to Enroll in the Clinical Trial

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    End point title
    		 Number of Subjects With Reasons to Enroll in the Clinical Trial [7]
    End point description
    The subjects decision to enroll in the clinical trial were reported with the use of subject interview guide. Subjects who shared their reasons (hope for the effective treatment, doctor's recommendations, desire to contribute in clinical research, family members encouragement, limited treatment options available, worry to loose eligibility for participation) to enroll in the qualitative interview study were reported in this endpoint.
    End point type
    Primary
    End point timeframe
    At Baseline
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
        Hope for the effective treatment
    10
        Doctor's recommendations
    5
        Desire to contribute in clinical research
    4
        Family members encouragement
    3
        Limited treatment options available
    2
        Worry to loose eligibility for participation
    1
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced New Symptoms After Clinical Trial Entry

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    End point title
    		 Number of Subjects Who Experienced New Symptoms After Clinical Trial Entry [8]
    End point description
    Subject interview guide was used to report any new symptoms they have experienced after clinical trial entry. The number of subjects who recalled any new symptoms that were not previously experienced (skin lesions, redness, burning, bleeding, itch, discomfort or pain, lack of energy, oozing, nausea, fever or chills, flu like symptoms, inflammation, headache) before the entering in the qualitative interview study were reported in this endpoint.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
        Skin Lesions
    3
        Redness
    1
        Burning
    3
        Bleeding
    2
        Itch
    1
        Discomfort or Pain
    1
        Lack of Energy
    1
        Oozing
    1
        Nausea
    2
        Fever or Chills
    2
        Flu Like Symptoms
    2
        Inflammation
    1
        Headache
    1
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced New Impacts After Clinical Trial Entry

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    End point title
    		 Number of Subjects Who Experienced New Impacts After Clinical Trial Entry [9]
    End point description
    Subject interview guide was used to report any new impacts they have experienced after clinical trial entry. The number of subjects who recalled any new impacts (work, exercise, relationships, wear gauze or bandage) that were not previously experienced before the entering in the qualitative interview study were reported in this endpoint.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
        Work
    1
        Exercise
    1
        Relationships
    1
        Wear Gauze or Bandage
    1
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Change in Symptoms During Clinical Trial at Week 24

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    End point title
    		 Number of Subjects Who Experienced Change in Symptoms During Clinical Trial at Week 24 [10]
    End point description
    The subject interview guide was used to grade their experience of change in symptoms (redness, dryness, itch, skin patches, blotchiness, skin sensitivity, discomfort or pain) into 'improvement, no change and worsening' during trial. The subjects who described their experience of change in symptoms were reported in this endpoint. Here, the number of subjects analysed signifies subjects who were evaluable for this endpoint. Here, n = number of subjects analysed for the specific categories.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 CTCL Stage IA CTCL Stage IB
    Number of subjects analysed
    10
    8
    Units: subjects
        Redness: Improvement (n=10,8)
    7
    6
        Redness: No Change (n=10,8)
    2
    1
        Redness: Worsening (n=10,8)
    1
    1
        Dryness: Improvement (n=9,7)
    2
    4
        Dryness: No change (n=9,7)
    6
    1
        Dryness: Worsening (n=9,7)
    1
    2
        Itch: Improvement (n=8,7)
    5
    6
        Itch: No Change (n=8,7)
    1
    0
        Itch: Worsening (n=8,7)
    2
    1
        Skin Patches: Improvement (n=8,6)
    5
    6
        Skin Patches: No Change (n=8,6)
    3
    0
        Skin Patches: Worsening (n=8,6)
    0
    0
        Blotchiness: Improvement (n=6,5)
    4
    3
        Blotchiness: No Change (n=6,5)
    2
    1
        Blotchiness: Worsening (n=6,5)
    0
    0
        Skin Sensitivity: Improvement (n=5,6)
    2
    3
        Skin Sensitivity: No Change (n=5,6)
    3
    0
        Skin Sensitivity: Worsening (n=5,6)
    0
    2
        Discomfort or Pain; Improvement(n=5,6)
    2
    4
        Discomfort or Pain; No Change (n=5,6)
    2
    0
        Discomfort or Pain; Worsening (n=5,6)
    1
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Change in Impacts During Clinical Trial at Week 24

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    End point title
    		 Number of Subjects Who Experienced Change in Impacts During Clinical Trial at Week 24 [11]
    End point description
    The subject interview guide was used to grade their experience of change in impacts (Embarrassment/Uncomfortable, Sleep Disruption, Altered Clothing Choices, Financial Burden) in to 'improvement, no change and worsening' during trial. The subjects who described their experience of change in impacts were reported in this endpoint. Here, the number of subjects analysed signifies subjects who were evaluable for this endpoint. Here, n = number of subjects analysed for the specific categories. Change in impacts during trial were not reported for two participants who did not complete up to week 24.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 CTCL Stage IA CTCL Stage IB
    Number of subjects analysed
    4
    7
    Units: subjects
        Embarrassment or Uncomfortable; Improvement (n=2,7
    1
    3
        Embarrassment or Uncomfortable; No Change (n=2,7)
    0
    3
        Embarrassment or Uncomfortable; Worsening (n=2,7)
    0
    0
        Sleep Disruption; Improvement (n=4,4)
    0
    2
        Sleep Disruption; No Change (n=4,4)
    3
    1
        Sleep Disruption; Worsening (n=4,4)
    1
    0
        Altered Clothing Choices; Improvement (n=2,5)
    0
    3
        Altered Clothing Choices; No Change (n=2,5)
    1
    0
        Altered Clothing Choices; Worsening (n=2,5)
    0
    2
        Financial Burden; Improvement (n=3,4)
    0
    1
        Financial Burden; No Change (n=3,4)
    2
    2
        Financial Burden; Worsening (n=3,4)
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Change in Symptom Rating (Redness) During Clinical Trial

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    End point title
    		 Number of Subjects Who Experienced Change in Symptom Rating (Redness) During Clinical Trial [12]
    End point description
    The subject interview guide was used to explore their experience of change in redness symptom into 'improvement, no change and worsening' during trial. The subjects rated the improvement into 'better', 'a little better' and 'much better' and the subjects rated the worsening into 'a little worse', 'worse' and 'much worse'. The subjects who described their experience of change in redness symptom rating and meaningful change from baseline were reported in this endpoint. Here, the number of subjects analysed signifies subjects who were evaluable for this endpoint. Here, n = number of subjects analysed for the specific categories. One subject did not provide the improvement change rating for redness symptom.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    18
    Units: subjects
        Improvement (A little better) (n=13)
    3
        Improvement (Better) (n=13)
    6
        Improvement (Much better) (n=13)
    3
        Improvement (Meaningful change) (n=13)
    13
        Worsening (A little worse) (n=2)
    2
        Worsening (Worse) (n=2)
    0
        Worsening (Much worse) (n=2)
    0
        Worsening (Meaningful change) (n=2)
    1
        No change
    3
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Change in Symptom Rating (Dryness) During Clinical Trial

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    End point title
    		 Number of Subjects Who Experienced Change in Symptom Rating (Dryness) During Clinical Trial [13]
    End point description
    The subject interview guide was used to explore their experience of change in dryness symptom into 'improvement, no change and worsening' during trial. The subjects rated the improvement into 'better', 'a little better' and 'much better' and the subjects rated the worsening into 'a little worse', 'worse' and 'much worse'. The subjects who described their experience of change in dryness symptom rating and meaningful change from baseline were reported in this endpoint. The number of subjects analysed signifies subjects who were evaluable for this endpoint. Here, n = number of subjects analysed for the specific categories.
    End point type
    Primary
    End point timeframe
    At week 24
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    16
    Units: subjects
        Improvement (A little better) (n=6)
    1
        Improvement (Better) (n=6)
    3
        Improvement (Much better) (n=6)
    2
        Improvement (Meaningful change) (n=6)
    6
        Worsening (A little worse) (n=3)
    0
        Worsening (Worse) (n=3)
    3
        Worsening (Much worse) (n=3)
    0
        Worsening- Meaningful change (n=3)
    3
        No change
    7
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Change in Symptom Rating (Itch) During Clinical Trial

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    End point title
    		 Number of Subjects Who Experienced Change in Symptom Rating (Itch) During Clinical Trial [14]
    End point description
    The subject interview guide was used to explore their experience of change in itch symptom into 'improvement, no change and worsening' during trial. The subjects rated the improvement into 'better', 'a little better' and 'much better' and the subjects rated the worsening into 'a little worse', 'worse' and 'much worse'. The subjects who described their experience of change in itch symptom rating and meaningful change from baseline were reported in this endpoint. Number of subjects analysed signifies subjects who were evaluable for this endpoint. Here, n = number of subjects analysed for the specific categories. One subject did not provide the itch symptom improvement and itch meaningful change rating .
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    11
    Units: subjects
        Improvement (A little better) (n=11)
    0
        Improvement (Better) (n=11)
    5
        Improvement (Much better) (n=11)
    6
        Improvement (Meaningful change) (n=11)
    10
        Worsening (A little worse) (n=3)
    2
        Worsening (Worse) (n=3)
    0
        Worsening (Much worse) (n=3)
    1
        Worsening- Meaningful change (n=3)
    2
        No change
    1
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Change in Symptom Rating (Skin patches) During Clinical Trial

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    End point title
    		 Number of Subjects Who Experienced Change in Symptom Rating (Skin patches) During Clinical Trial [15]
    End point description
    The subject interview guide was used to explore their experience of change in skin patches symptom into 'improvement, no change and worsening' during trial. The subjects rated the improvement into 'better', 'a little better' and 'much better' and the subjects rated the worsening into 'a little worse', 'worse' and 'much worse'. The subjects who described their experience of change in skin patches symptom rating and meaningful change from baseline were reported in this endpoint. Number of subjects analysed signifies subjects who were evaluable for this endpoint. Here, n = number of subjects analysed for the specific categories.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    14
    Units: subjects
        Improvement (A little better) (n=11)
    3
        Improvement (Better) (n=11)
    5
        Improvement (Much better) (n=11)
    3
        Improvement (Meaningful change) (n=11)
    10
        Worsening (A little worse) (n=0)
    0
        Worsening (Worse) (n=0)
    0
        Worsening (Much worse) (n=0)
    0
        Worsening (Meaningful change) (n=0)
    0
        No change
    3
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Change in Symptoms Rating (Blotchiness) During Clinical Trial

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    End point title
    		 Number of Subjects Who Experienced Change in Symptoms Rating (Blotchiness) During Clinical Trial [16]
    End point description
    The subject interview guide was used to explore their experience of change in blotchiness symptom into 'improvement, no change and worsening' during trial. The subjects rated the improvement into 'better', 'a little better' and 'much better' and the subjects rated the worsening into 'a little worse', 'worse' and 'much worse'. The subjects who described their experience of change in blotchiness symptom rating and meaningful change from baseline were reported. Number of subjects analysed signifies subjects who were evaluable for this endpoint. Here, n = number of subjects analysed for the specific categories. Blotchiness improvement change rating was not reported for one subject and two subjects did not provided improvement meaningful change rating.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    11
    Units: subjects
        Improvement (A little better) (n=7)
    2
        Improvement (Better) (n=7)
    1
        Improvement (Much better) (n=7)
    3
        Improvement ( Meaningful change) (n=7)
    5
        Worsening (A little worse) (n=0)
    0
        Worsening (Worse) (n=0)
    0
        Worsening (Much worse) (n=0)
    0
        Worsening- Meaningful change (n=0)
    0
        No change
    3
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Change in Symptom Rating (Discomfort or Pain) During Clinical Trial

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    End point title
    		 Number of Subjects Who Experienced Change in Symptom Rating (Discomfort or Pain) During Clinical Trial [17]
    End point description
    The subject interview guide was used to explore their experience of change in discomfort or pain symptom into 'improvement, no change and worsening' during trial. The subjects rated the improvement into 'better', 'a little better' and 'much better' and the subjects rated the worsening into 'a little worse', 'worse' and 'much worse'. The subjects who described their experience of change in discomfort or pain symptom rating and meaningful change from baseline were reported. Number of subjects analysed signifies subjects who were evaluable for this endpoint. Here, n = number of subjects analysed for the specific categories. One subject did not provide improvement meaningful change rating.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    11
    Units: subjects
        Improvement (A little better) (n=6)
    0
        Improvement (Better) (n=6)
    2
        Improvement (Much better) (n=6)
    4
        Improvement (Meaningful change) (n=6)
    5
        Worsening (A little worse) (n=1)
    0
        Worsening (Worse) (n=1)
    1
        Worsening (Much Worse) (n=1)
    0
        Worsening (Meaningful change) (n=1)
    1
        No change
    2
    No statistical analyses for this end point

    Primary: Number of Subjects Who Reported Treatment Expectations

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    End point title
    		 Number of Subjects Who Reported Treatment Expectations [18]
    End point description
    The subjects responded that their treatment expectations were 'met or not met' based on the changes observed in the appearance of their skin, worsening of symptoms or lack of long-lasting therapy. The number of subjects who described their treatment expectations were reported in this endpoint. Here, the number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    17
    Units: subjects
        Expectations met
    12
        Expectations not met
    5
    No statistical analyses for this end point

    Primary: Mean Treatment Satisfaction of Subjects

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    End point title
    		 Mean Treatment Satisfaction of Subjects [19]
    End point description
    The subject interview guide were used explore subjects experience of their level of satisfaction. Subjects rated their level of treatment satisfaction on a scale from zero to 10 where zero indicated "not satisfied at all" and 10 indicated "extremely satisfied". The number of subjects who rated their level of satisfaction were reported in this endpoint. Here, the number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: Score on scale
        arithmetic mean (standard deviation)
    6.4 ± 3.1
    No statistical analyses for this end point

    Primary: Number of Subjects With Positive and Negative Clinical Trial Experience

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    End point title
    		 Number of Subjects With Positive and Negative Clinical Trial Experience [20]
    End point description
    The subject interview guide was used to explore subjects experience after entering in to the trial. Positive and negative trial experience questioner examples included professionalism, attentiveness, responsiveness, and friendliness of the trial staff, well-organized trial, comfortable interaction with the trial staff, clear guidance and instructions, ease of application of the gel, getting to the appointments. The subjects who reported positive and negative trial experience were reported in this endpoint. Here, the number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
        Positive Experience
    18
        Negative Experience
    5
    No statistical analyses for this end point

    Primary: Number of Subjects Who Recommended Changes in Clinical Trial

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    End point title
    		 Number of Subjects Who Recommended Changes in Clinical Trial [21]
    End point description
    The subject interview guide was used to explore their experience of the trial. Subjects reported their suggestions for changes they would recommend to the trial procedures such as improved laboratory procedures, better coordination with laboratory and medical staff on trial visits, quicker release of lab work, and more education from staff on trial procedures and extension to the trial. The number of subjects who recommended trial changes were reported in this endpoint. Here, the number of subjects analysed signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    19
    Units: subjects
    8
    No statistical analyses for this end point

    Primary: Number of Subjects Who Experienced Change in Symptom Rating (Skin Sensitivity) During Clinical Trial

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    End point title
    		 Number of Subjects Who Experienced Change in Symptom Rating (Skin Sensitivity) During Clinical Trial [22]
    End point description
    The subject interview guide was used to explore their experience of change in skin sensitivity symptom into 'improvement, no change and worsening' during trial. The subjects rated the improvement into 'better', 'a little better' and 'much better' and the subjects rated the worsening into 'a little worse', 'worse' and 'much worse'. The subjects who described their experience of change in skin sensitivity symptom rating and meaningful change from baseline were reported. Number of subjects analysed signifies subjects who were evaluable for this endpoint. Here, n = number of subjects analysed for the specific categories.
    End point type
    Primary
    End point timeframe
    At Week 24
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only Descriptive data was planned to be analyzed.
    End point values
    		 Total Number Of Subjects in Exit Interview Sample Study
    Number of subjects analysed
    11
    Units: subjects
        Improvement (A little better) (n=5)
    0
        Improvement (Better) (n=5)
    3
        Improvement (Much better) (n=5)
    2
        Improvement (Meaningful change) (n=5)
    5
        Worsening (A little worse) (n=2)
    1
        Worsening (Worse) (n=2)
    1
        Worsening (Much Worse) (n=2)
    0
        Worsening (Meaningful change) (n=2)
    1
        No change
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to Week 24
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    CTCL Stage IA
    Reporting group description
    		 Subjects who had early CTCL stage disease (CTCL stage IA) were treated with placebo and resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 1 followed by resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 2. Subjects who treated with placebo in Cycle 1 received resiquimod gel 0.03% during Cycle 2. The two treatment cycles were having duration of 12 weeks of each (eight weeks of treatment plus four weeks of treatment-free) were followed by a 12 week treatment-free follow-up period. Those eligible trial subjects were interviewed after completion of either of the treatment cycle for 3 weeks.

    Reporting group title
    CTCL Stage IB
    Reporting group description
    		 Subjects who had early CTCL stage disease (CTCL stage IB) were treated with placebo and resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 1 followed by resiquimod gel (0.03% or 0.06%) for eight weeks during Cycle 2. Subjects who treated with placebo in Cycle 1 received resiquimod gel 0.03% during Cycle 2. The two treatment cycles were having duration of 12 weeks of each (eight weeks of treatment plus four weeks of treatment-free) were followed by a 12 weeks treatment-free follow-up period. Those eligible trial participants were interviewed after completion of either of the treatment cycle for 3 weeks.

    Serious adverse events
    		 CTCL Stage IA CTCL Stage IB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 CTCL Stage IA CTCL Stage IB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    8 / 8 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Mycosis fungoides
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 8 (12.50%)
         occurrences all number
    3
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    Phlebitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site dermatitis
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 8 (25.00%)
         occurrences all number
    7
    9
    Application site erosion
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 8 (12.50%)
         occurrences all number
    3
    1
    Application site erythema
         subjects affected / exposed
    4 / 11 (36.36%)
    1 / 8 (12.50%)
         occurrences all number
    12
    1
    Application site pain
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    Application site papules
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Application site pruritus
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 8 (25.00%)
         occurrences all number
    5
    5
    Application site ulcer
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Application site rash
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Application site vesicles
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Laceration
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Proctalgia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Investigations
    Bacterial test positive
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Glucose urine present
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Eye infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood albumin increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Gamma-Glutamyl transferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Tri-iodothyronine decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Application site erosion
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Application site ulcer
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood urine present
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Application site ulcer
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Bundle branch block left
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    6
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Keratitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    Pruritis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Skin erosion
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Papule
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Maematuria
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 8 (12.50%)
         occurrences all number
    1
    2
    Aneurysmal bone cyst
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 8 (25.00%)
         occurrences all number
    1
    2

    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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    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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