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This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers.
The objectives of this clinical trial are to compare the efficacy of twice-daily topical LEO 124249 30 mg/g ointment with LEO 124249 ointment vehicle for 12 weeks in the treatment of hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to evaluate hair regrowth, to determine subject quality of life, and to explore disease mechanism and its biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 124249 | Experimental | LEO 124249 ointment 30 mg/g twice daily |
|
| Vehicle | Placebo Comparator | LEO 124249 ointment vehicle twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 124249 | Drug |
|
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Severity of Alopecia Areata Tool (SALT) Score | The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. | From baseline (Day 1) to Week 12 (Day 84) |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Absolute SALT Score | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. Summary of observed values of the absolute SALT score. | At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emma Guttman, MD, PhD | The Icahn School of Medicine, Mount Sinai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Evanston | Illinois | 60208 | United States | ||
| The Icahn School of Medicine, Mount Sinai Hospital |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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A total of 40 participants were screened, 9 participants were screening failures, and the remaining 31 participants were randomized as follows: 20 participants to LEO 124249 ointment 30 mg/g group and 11 participants to LEO 124249 ointment vehicle group.
Date of First Subject First Visit: 02-Feb-2016 Date of Last Subject Last Visit: 06-Dec-2016
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 124249 | LEO 124249 ointment 30 mg/g twice daily |
| FG001 | LEO 124249 Vehicle | LEO 124249 ointment vehicle twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 124249 | LEO 124249 ointment 30 mg/g twice daily |
| BG001 | LEO 124249 Vehicle | LEO 124249 ointment vehicle twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Severity of Alopecia Areata Tool (SALT) Score | The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants completing Week 12 have been included in the calculation of the change from baseline in the SALT score. | Posted | Mean | Standard Deviation | units on a scale | From baseline (Day 1) to Week 12 (Day 84) |
|
From screening (within 28 days prior to Day 1) to end of trial (Week 14)
Treatment emergent adverse events are reported from baseline (Day 1) to end of trial (Week 14). No adverse events was reported prior to Day 1.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LEO 124249 | LEO 124249 ointment 30 mg/g twice daily | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Folliculitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 4494 5888 | disclosure@leo-pharma.com |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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| Other |
|
|
| Summary of Change in SALT Score |
The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. |
| From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) |
| Summary of Relative Change in SALT Score | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) |
| Percentage of Patients Who Achieve 50% Improvement in the SALT Score | The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1) | At Week 12 (Day 84) |
| Hair Length | Hair length measured in millimeters. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
| Hair Growth Rate | Change in hair length measured in millimeters per day. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
| Relative Hair Thickness | Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
| Hair Type | Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
| Hair Color | Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
| Global Assessment of Overall Hair Regrowth Compared to Baseline | Based on standardized photographs | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
| Participant's Global Assessment of Hair Regrowth | The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth. | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
| Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | The scale includes 21 questions measuring the degree to which the patient was affected by the AA in the last month, scored from 1 (not affected at all) to 4 (highly affected). The AA-QLI transformed scores for each of the subcategories 'subjective symptoms', 'relationship' and 'objective signs' ranging from (min-max) 9-36, 9-36, and 3-12. Total score ranges from 0-84. Low score indicating that the participant was least affected by AA. | At baseline (Day 1) and at Week 12 (Day 84) |
| Treatment Satisfaction Questionnaire for Medication Score | The Treatment Satisfaction Questionnaire for Medication (TSQM II) is a validated, general measure of treatment satisfaction for medication - accounting for effectiveness, side effects, convenience, and global satisfaction - that is comparable across medication types and patient conditions. The individual derived score for each of the 4 dimensions (effectiveness, side effects, convenience, and global satisfaction) of the TSQM II questionnaire ranged from 0-100, with a higher score indicating greater satisfaction to treatment. | At Week 12 (Day 84) |
| New York |
| New York |
| 10029 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | LEO 124249 Vehicle | LEO 124249 ointment vehicle twice daily application |
|
|
|
| Secondary | Summary of Absolute SALT Score | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. Summary of observed values of the absolute SALT score. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
|
|
|
| Secondary | Summary of Change in SALT Score | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) |
|
|
|
| Secondary | Summary of Relative Change in SALT Score | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Mean | Standard Deviation | percentage change | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) |
|
|
|
| Secondary | Percentage of Patients Who Achieve 50% Improvement in the SALT Score | The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11). Only the participants completing Week 12 have been included in the analysis. | Posted | Count of Participants | Participants | At Week 12 (Day 84) |
|
|
|
| Secondary | Hair Length | Hair length measured in millimeters. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Mean | Standard Deviation | mm | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
|
|
|
| Secondary | Hair Growth Rate | Change in hair length measured in millimeters per day. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Mean | Standard Deviation | mm/day | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
|
|
|
| Secondary | Relative Hair Thickness | Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Count of Participants | Participants | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
|
|
|
| Secondary | Hair Type | Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Count of Participants | Participants | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
|
|
|
| Secondary | Hair Color | Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Count of Participants | Participants | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
|
|
|
| Secondary | Global Assessment of Overall Hair Regrowth Compared to Baseline | Based on standardized photographs | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Count of Participants | Participants | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
|
|
|
| Secondary | Participant's Global Assessment of Hair Regrowth | The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Count of Participants | Participants | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) |
|
|
|
| Secondary | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | The scale includes 21 questions measuring the degree to which the patient was affected by the AA in the last month, scored from 1 (not affected at all) to 4 (highly affected). The AA-QLI transformed scores for each of the subcategories 'subjective symptoms', 'relationship' and 'objective signs' ranging from (min-max) 9-36, 9-36, and 3-12. Total score ranges from 0-84. Low score indicating that the participant was least affected by AA. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | At baseline (Day 1) and at Week 12 (Day 84) |
|
|
|
| Secondary | Treatment Satisfaction Questionnaire for Medication Score | The Treatment Satisfaction Questionnaire for Medication (TSQM II) is a validated, general measure of treatment satisfaction for medication - accounting for effectiveness, side effects, convenience, and global satisfaction - that is comparable across medication types and patient conditions. The individual derived score for each of the 4 dimensions (effectiveness, side effects, convenience, and global satisfaction) of the TSQM II questionnaire ranged from 0-100, with a higher score indicating greater satisfaction to treatment. | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | At Week 12 (Day 84) |
|
|
|
| 20 |
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | LEO 124249 Vehicle | LEO 124249 ointment vehicle twice daily | 0 | 11 | 0 | 11 | 2 | 11 |
| Conjunctivitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Week 4 (Day 28) |
|
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| Week 8 (Day 56) |
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| Week 12 (Day 84) |
|
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| Baseline (Day 1) to Week 8 (Day 56) |
|
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| Baseline (Day 1) to Week 12 (Day 84) |
|
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| Baseline (Day 1) to Week 8 (Day 56) |
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| Baseline (Day 1) to Week 12 (Day 84) |
|
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| Week 8 (Day 56) |
|
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| Week 12 (Day 84) |
|
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| Week 8 (Day 56) |
|
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| Week 12 (Day 84) |
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| Slightly thinner |
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| Same thickness |
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| Week 8 (Day 56) |
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| Week 12 (Day 84) |
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| Velus hair |
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| Week 8 (Day 56) |
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| Week 12 (Day 84) |
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| Blond |
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| Brown |
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| Gray |
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| Red |
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| White |
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| Week 8 (Day 56) |
|
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| Week 12 (Day 84) |
|
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| Moderately worse |
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| Slightly worse |
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| Unchanged |
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| Slightly improved |
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| Moderately improved |
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| Much improved |
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| Week 8 (Day 56) |
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| Week 12 (Day 84) |
|
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| <25% of regrowth |
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| 25%-49% of regrowth |
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| 50%-74% of regrowth |
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| 75%-99% of regrowth |
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| 100% of regrowth |
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| Week 8 (Day 56) |
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| Week 12 (Day 84) |
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| Relationship |
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| Objective signs |
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| Total score |
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| Side effects |
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| Convenience |
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| Global satisfaction |
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