Alopecia Areata
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGLEO 124249
OTHERVehicle
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have signed and dated informed consent after receiving verbal and written information about the clinical trial. * Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia areata (patch type, totalis, universalis), as determined by the (sub) investigator, affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1, baseline). * Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time limit. * Subject must accept to not cut hair in the treated scalp areas during the trial.
Exclusion criteria
* Females who are pregnant or are breast feeding. * Current signs of spontaneous hair regrowth. * Diffuse type alopecia areata. * Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and Ludwig stage II and III) * Subjects with changed or expected changes in medication for thyroid disease within 6 month before Visit 1 (screening) or during the trial. * Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Alopecia Areata Tool (SALT) Score | From baseline (Day 1) to Week 12 (Day 84) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Change in SALT Score | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | 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. |
| Summary of Relative Change in SALT Score | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | 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. |
| Percentage of Patients Who Achieve 50% Improvement in the SALT Score | At Week 12 (Day 84) | The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1) |
| Hair Length | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Hair length measured in millimeters. |
| Hair Growth Rate | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Change in hair length measured in millimeters per day. |
| Relative Hair Thickness | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis. |
| Summary of Absolute SALT Score | At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 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. |
| Hair Color | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis. |
| Global Assessment of Overall Hair Regrowth Compared to Baseline | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Based on standardized photographs |
| Participant's Global Assessment of Hair Regrowth | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth. |
| Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | At baseline (Day 1) and at Week 12 (Day 84) | 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. |
| Treatment Satisfaction Questionnaire for Medication Score | At Week 12 (Day 84) | 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. |
| Hair Type | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis. |
Countries
United States
Participant flow
Recruitment details
Date of First Subject First Visit: 02-Feb-2016 Date of Last Subject Last Visit: 06-Dec-2016
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| LEO 124249 LEO 124249 ointment 30 mg/g twice daily | 20 |
| LEO 124249 Vehicle LEO 124249 ointment vehicle twice daily | 11 |
| Total | 31 |
Baseline characteristics
| Characteristic | LEO 124249 Vehicle | LEO 124249 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 20 Participants | 31 Participants |
| Age, Continuous | 32.1 years STANDARD_DEVIATION 8.2 | 36.4 years STANDARD_DEVIATION 14 | 34.9 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 11 Participants | 20 Participants | 31 Participants |
| Sex: Female, Male Female | 5 Participants | 14 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 11 |
| other Total, other adverse events | 5 / 20 | 2 / 11 |
| serious Total, serious adverse events | 0 / 20 | 0 / 11 |
Outcome results
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.
Time frame: From baseline (Day 1) to Week 12 (Day 84)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 124249 | Change in Severity of Alopecia Areata Tool (SALT) Score | -3.8 units on a scale | Standard Deviation 9.3 |
| LEO 124249 Vehicle | Change in Severity of Alopecia Areata Tool (SALT) Score | -3.4 units on a scale | Standard Deviation 17 |
p-value: 0.9795% CI: [-12.05, 11.65]t-test, 2 sided
Secondary
Global Assessment of Overall Hair Regrowth Compared to Baseline
Based on standardized photographs
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Much worse | 0 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Moderately worse | 1 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Slightly worse | 1 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Unchanged | 15 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Slightly improved | 2 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Moderately improved | 0 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Much improved | 0 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Much worse | 0 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Moderately worse | 0 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Slightly worse | 2 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Unchanged | 14 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Slightly improved | 2 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Moderately improved | 0 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Much improved | 0 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Much worse | 0 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Moderately worse | 0 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Slightly worse | 2 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Unchanged | 9 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Slightly improved | 5 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Moderately improved | 1 Participants |
| LEO 124249 | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Much improved | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Unchanged | 5 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Much worse | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Slightly improved | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Moderately worse | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Slightly improved | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Slightly worse | 1 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Slightly worse | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Unchanged | 8 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Moderately improved | 1 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Slightly improved | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Much improved | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Moderately improved | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Much improved | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 4 (Day 28) | Much improved | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Unchanged | 4 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Much worse | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Much worse | 1 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Moderately worse | 1 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Moderately improved | 1 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 8 (Day 56) | Slightly worse | 0 Participants |
| LEO 124249 Vehicle | Global Assessment of Overall Hair Regrowth Compared to Baseline | Week 12 (Day 84) | Moderately worse | 0 Participants |
Secondary
Hair Color
Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis.
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 124249 | Hair Color | Week 12 (Day 84) | Black | 4 Participants |
| LEO 124249 | Hair Color | Week 12 (Day 84) | Blond | 1 Participants |
| LEO 124249 | Hair Color | Week 4 (Day 28) | Black | 4 Participants |
| LEO 124249 | Hair Color | Week 4 (Day 28) | Blond | 2 Participants |
| LEO 124249 | Hair Color | Week 4 (Day 28) | Brown | 3 Participants |
| LEO 124249 | Hair Color | Week 4 (Day 28) | Gray | 0 Participants |
| LEO 124249 | Hair Color | Week 4 (Day 28) | Red | 0 Participants |
| LEO 124249 | Hair Color | Week 4 (Day 28) | White | 5 Participants |
| LEO 124249 | Hair Color | Week 8 (Day 56) | Black | 4 Participants |
| LEO 124249 | Hair Color | Week 8 (Day 56) | Blond | 1 Participants |
| LEO 124249 | Hair Color | Week 8 (Day 56) | Brown | 4 Participants |
| LEO 124249 | Hair Color | Week 8 (Day 56) | Gray | 0 Participants |
| LEO 124249 | Hair Color | Week 8 (Day 56) | Red | 0 Participants |
| LEO 124249 | Hair Color | Week 8 (Day 56) | White | 5 Participants |
| LEO 124249 | Hair Color | Week 12 (Day 84) | Brown | 2 Participants |
| LEO 124249 | Hair Color | Week 12 (Day 84) | Gray | 0 Participants |
| LEO 124249 | Hair Color | Week 12 (Day 84) | Red | 1 Participants |
| LEO 124249 | Hair Color | Week 12 (Day 84) | White | 4 Participants |
| LEO 124249 Vehicle | Hair Color | Week 8 (Day 56) | White | 1 Participants |
| LEO 124249 Vehicle | Hair Color | Week 12 (Day 84) | Black | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 8 (Day 56) | Blond | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 12 (Day 84) | Blond | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 12 (Day 84) | White | 3 Participants |
| LEO 124249 Vehicle | Hair Color | Week 4 (Day 28) | Black | 1 Participants |
| LEO 124249 Vehicle | Hair Color | Week 8 (Day 56) | Brown | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 4 (Day 28) | Blond | 1 Participants |
| LEO 124249 Vehicle | Hair Color | Week 12 (Day 84) | Brown | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 4 (Day 28) | Brown | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 8 (Day 56) | Gray | 1 Participants |
| LEO 124249 Vehicle | Hair Color | Week 4 (Day 28) | Gray | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 12 (Day 84) | Red | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 4 (Day 28) | Red | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 8 (Day 56) | Red | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 4 (Day 28) | White | 1 Participants |
| LEO 124249 Vehicle | Hair Color | Week 12 (Day 84) | Gray | 0 Participants |
| LEO 124249 Vehicle | Hair Color | Week 8 (Day 56) | Black | 1 Participants |
Secondary
Hair Growth Rate
Change in hair length measured in millimeters per day.
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 124249 | Hair Growth Rate | Week 4 (Day 28) | 0.4 mm/day | Standard Deviation 0.7 |
| LEO 124249 | Hair Growth Rate | Week 8 (Day 56) | 0.2 mm/day | Standard Deviation 0.3 |
| LEO 124249 | Hair Growth Rate | Week 12 (Day 84) | 0.3 mm/day | Standard Deviation 0.8 |
| LEO 124249 Vehicle | Hair Growth Rate | Week 4 (Day 28) | 0.1 mm/day | Standard Deviation 0.2 |
| LEO 124249 Vehicle | Hair Growth Rate | Week 8 (Day 56) | 0.1 mm/day | Standard Deviation 0.5 |
| LEO 124249 Vehicle | Hair Growth Rate | Week 12 (Day 84) | 0.1 mm/day | Standard Deviation 0.5 |
Secondary
Hair Length
Hair length measured in millimeters.
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 124249 | Hair Length | Week 4 (Day 28) | 12.7 mm | Standard Deviation 17 |
| LEO 124249 | Hair Length | Week 8 (Day 56) | 18.2 mm | Standard Deviation 21.7 |
| LEO 124249 | Hair Length | Week 12 (Day 84) | 25.1 mm | Standard Deviation 31.8 |
| LEO 124249 Vehicle | Hair Length | Week 4 (Day 28) | 5.6 mm | Standard Deviation 8.4 |
| LEO 124249 Vehicle | Hair Length | Week 8 (Day 56) | 10.3 mm | Standard Deviation 16.9 |
| LEO 124249 Vehicle | Hair Length | Week 12 (Day 84) | 16.3 mm | Standard Deviation 23.5 |
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.
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 124249 | Hair Type | Week 4 (Day 28) | Terminal hair | 4 Participants |
| LEO 124249 | Hair Type | Week 4 (Day 28) | Velus hair | 9 Participants |
| LEO 124249 | Hair Type | Week 8 (Day 56) | Terminal hair | 4 Participants |
| LEO 124249 | Hair Type | Week 8 (Day 56) | Velus hair | 9 Participants |
| LEO 124249 | Hair Type | Week 12 (Day 84) | Terminal hair | 6 Participants |
| LEO 124249 | Hair Type | Week 12 (Day 84) | Velus hair | 6 Participants |
| LEO 124249 Vehicle | Hair Type | Week 12 (Day 84) | Terminal hair | 1 Participants |
| LEO 124249 Vehicle | Hair Type | Week 4 (Day 28) | Terminal hair | 1 Participants |
| LEO 124249 Vehicle | Hair Type | Week 8 (Day 56) | Velus hair | 1 Participants |
| LEO 124249 Vehicle | Hair Type | Week 4 (Day 28) | Velus hair | 2 Participants |
| LEO 124249 Vehicle | Hair Type | Week 12 (Day 84) | Velus hair | 2 Participants |
| LEO 124249 Vehicle | Hair Type | Week 8 (Day 56) | Terminal hair | 2 Participants |
Secondary
Participant's Global Assessment of Hair Regrowth
The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth.
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | No regrowth | 8 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | <25% of regrowth | 8 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | 25%-49% of regrowth | 2 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | 50%-74% of regrowth | 0 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | 75%-99% of regrowth | 0 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | 100% of regrowth | 0 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | No regrowth | 8 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | <25% of regrowth | 8 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | 25%-49% of regrowth | 0 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | 50%-74% of regrowth | 2 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | 75%-99% of regrowth | 0 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | 100% of regrowth | 0 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | No regrowth | 6 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | <25% of regrowth | 8 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | 25%-49% of regrowth | 1 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | 50%-74% of regrowth | 2 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | 75%-99% of regrowth | 0 Participants |
| LEO 124249 | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | 100% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | <25% of regrowth | 1 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | No regrowth | 6 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | 50%-74% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | <25% of regrowth | 3 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | 100% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | 25%-49% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | 75%-99% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | 50%-74% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | 25%-49% of regrowth | 1 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | 75%-99% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | 100% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 4 (Day 28) | 100% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | 75%-99% of regrowth | 0 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | No regrowth | 5 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | No regrowth | 3 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | <25% of regrowth | 1 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 12 (Day 84) | 50%-74% of regrowth | 1 Participants |
| LEO 124249 Vehicle | Participant's Global Assessment of Hair Regrowth | Week 8 (Day 56) | 25%-49% of regrowth | 1 Participants |
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)
Time frame: At Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 124249 | Percentage of Patients Who Achieve 50% Improvement in the SALT Score | Yes | 2 Participants |
| LEO 124249 | Percentage of Patients Who Achieve 50% Improvement in the SALT Score | No | 15 Participants |
| LEO 124249 Vehicle | Percentage of Patients Who Achieve 50% Improvement in the SALT Score | Yes | 1 Participants |
| LEO 124249 Vehicle | Percentage of Patients Who Achieve 50% Improvement in the SALT Score | No | 5 Participants |
Secondary
Relative Hair Thickness
Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis.
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LEO 124249 | Relative Hair Thickness | Week 4 (Day 28) | Slightly thinner | 1 Participants |
| LEO 124249 | Relative Hair Thickness | Week 8 (Day 56) | Same thickness | 1 Participants |
| LEO 124249 | Relative Hair Thickness | Week 8 (Day 56) | Much thinner | 6 Participants |
| LEO 124249 | Relative Hair Thickness | Week 12 (Day 84) | Much thinner | 4 Participants |
| LEO 124249 | Relative Hair Thickness | Week 4 (Day 28) | Same thickness | 0 Participants |
| LEO 124249 | Relative Hair Thickness | Week 12 (Day 84) | Slightly thinner | 1 Participants |
| LEO 124249 | Relative Hair Thickness | Week 8 (Day 56) | Slightly thinner | 1 Participants |
| LEO 124249 | Relative Hair Thickness | Week 12 (Day 84) | Same thickness | 1 Participants |
| LEO 124249 | Relative Hair Thickness | Week 4 (Day 28) | Much thinner | 10 Participants |
| LEO 124249 Vehicle | Relative Hair Thickness | Week 12 (Day 84) | Same thickness | 0 Participants |
| LEO 124249 Vehicle | Relative Hair Thickness | Week 4 (Day 28) | Much thinner | 1 Participants |
| LEO 124249 Vehicle | Relative Hair Thickness | Week 4 (Day 28) | Slightly thinner | 0 Participants |
| LEO 124249 Vehicle | Relative Hair Thickness | Week 4 (Day 28) | Same thickness | 0 Participants |
| LEO 124249 Vehicle | Relative Hair Thickness | Week 8 (Day 56) | Much thinner | 1 Participants |
| LEO 124249 Vehicle | Relative Hair Thickness | Week 8 (Day 56) | Slightly thinner | 1 Participants |
| LEO 124249 Vehicle | Relative Hair Thickness | Week 8 (Day 56) | Same thickness | 0 Participants |
| LEO 124249 Vehicle | Relative Hair Thickness | Week 12 (Day 84) | Much thinner | 1 Participants |
| LEO 124249 Vehicle | Relative Hair Thickness | Week 12 (Day 84) | Slightly thinner | 1 Participants |
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.
Time frame: At baseline (Day 1) and at Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 124249 | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Subjective symptoms | 25.9 units on a scale | Standard Deviation 4.9 |
| LEO 124249 | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Relationship | 18.7 units on a scale | Standard Deviation 6.8 |
| LEO 124249 | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Objective signs | 7.8 units on a scale | Standard Deviation 2.4 |
| LEO 124249 | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Total score | 52.3 units on a scale | Standard Deviation 12.1 |
| LEO 124249 Vehicle | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Relationship | 17.5 units on a scale | Standard Deviation 6.7 |
| LEO 124249 Vehicle | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Objective signs | 8.4 units on a scale | Standard Deviation 2.2 |
| LEO 124249 Vehicle | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Total score | 50.2 units on a scale | Standard Deviation 11.1 |
| LEO 124249 Vehicle | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Subjective symptoms | 24.3 units on a scale | Standard Deviation 5.5 |
| Week 12: LEO 124249 | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Objective signs | 6.9 units on a scale | Standard Deviation 2.3 |
| Week 12: LEO 124249 | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Relationship | 18.7 units on a scale | Standard Deviation 7.2 |
| Week 12: LEO 124249 | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Total score | 51.1 units on a scale | Standard Deviation 12.5 |
| Week 12: LEO 124249 | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Subjective symptoms | 25.5 units on a scale | Standard Deviation 4.4 |
| Week 12: LEO 124249 Vehicle | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Total score | 48.2 units on a scale | Standard Deviation 15.2 |
| Week 12: LEO 124249 Vehicle | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Relationship | 16.8 units on a scale | Standard Deviation 7.5 |
| Week 12: LEO 124249 Vehicle | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Subjective symptoms | 23.7 units on a scale | Standard Deviation 7.3 |
| Week 12: LEO 124249 Vehicle | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | Objective signs | 7.7 units on a scale | Standard Deviation 2.7 |
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.
Time frame: At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 124249 | Summary of Absolute SALT Score | Baseline (Day 1) | 67.2 units on a scale | Standard Deviation 25.1 |
| LEO 124249 | Summary of Absolute SALT Score | Week 4 (Day 28) | 63.1 units on a scale | Standard Deviation 26.7 |
| LEO 124249 | Summary of Absolute SALT Score | Week 8 (Day 56) | 62.7 units on a scale | Standard Deviation 27.5 |
| LEO 124249 | Summary of Absolute SALT Score | Week 12 (Day 84) | 61.2 units on a scale | Standard Deviation 28.9 |
| LEO 124249 Vehicle | Summary of Absolute SALT Score | Week 12 (Day 84) | 66.4 units on a scale | Standard Deviation 38 |
| LEO 124249 Vehicle | Summary of Absolute SALT Score | Baseline (Day 1) | 74.4 units on a scale | Standard Deviation 24.3 |
| LEO 124249 Vehicle | Summary of Absolute SALT Score | Week 8 (Day 56) | 68.6 units on a scale | Standard Deviation 31.2 |
| LEO 124249 Vehicle | Summary of Absolute SALT Score | Week 4 (Day 28) | 71.0 units on a scale | Standard Deviation 25.9 |
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.
Time frame: From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 124249 | Summary of Change in SALT Score | Baseline (Day 1) to Week 4 (Day 28) | -2.2 units on a scale | Standard Deviation 4.4 |
| LEO 124249 | Summary of Change in SALT Score | Baseline (Day 1) to Week 8 (Day 56) | -2.5 units on a scale | Standard Deviation 7.3 |
| LEO 124249 | Summary of Change in SALT Score | Baseline (Day 1) to Week 12 (Day 84) | -3.8 units on a scale | Standard Deviation 9.3 |
| LEO 124249 Vehicle | Summary of Change in SALT Score | Baseline (Day 1) to Week 4 (Day 28) | 0.0 units on a scale | Standard Deviation 1.3 |
| LEO 124249 Vehicle | Summary of Change in SALT Score | Baseline (Day 1) to Week 8 (Day 56) | -1.5 units on a scale | Standard Deviation 9.6 |
| LEO 124249 Vehicle | Summary of Change in SALT Score | Baseline (Day 1) to Week 12 (Day 84) | -3.4 units on a scale | Standard Deviation 17 |
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.
Time frame: From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 124249 | Summary of Relative Change in SALT Score | Baseline (Day 1) to Week 4 (Day 28) | -4.6 percentage change | Standard Deviation 9 |
| LEO 124249 | Summary of Relative Change in SALT Score | Baseline (Day 1) to Week 8 (Day 56) | -5.6 percentage change | Standard Deviation 17.8 |
| LEO 124249 | Summary of Relative Change in SALT Score | Baseline (Day 1) to Week 12 (Day 84) | -7.7 percentage change | Standard Deviation 22.3 |
| LEO 124249 Vehicle | Summary of Relative Change in SALT Score | Baseline (Day 1) to Week 4 (Day 28) | -0.3 percentage change | Standard Deviation 2.3 |
| LEO 124249 Vehicle | Summary of Relative Change in SALT Score | Baseline (Day 1) to Week 8 (Day 56) | -5.3 percentage change | Standard Deviation 16.9 |
| LEO 124249 Vehicle | Summary of Relative Change in SALT Score | Baseline (Day 1) to Week 12 (Day 84) | -9.1 percentage change | Standard Deviation 32.5 |
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.
Time frame: At Week 12 (Day 84)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEO 124249 | Treatment Satisfaction Questionnaire for Medication Score | Convenience | 52.3 units on a scale | Standard Deviation 17.7 |
| LEO 124249 | Treatment Satisfaction Questionnaire for Medication Score | Effectiveness | 28.9 units on a scale | Standard Deviation 23.2 |
| LEO 124249 | Treatment Satisfaction Questionnaire for Medication Score | Global satisfaction | 40.7 units on a scale | Standard Deviation 22.6 |
| LEO 124249 | Treatment Satisfaction Questionnaire for Medication Score | Side effects | 94.5 units on a scale | Standard Deviation 15.1 |
| LEO 124249 Vehicle | Treatment Satisfaction Questionnaire for Medication Score | Global satisfaction | 47.2 units on a scale | Standard Deviation 22.8 |
| LEO 124249 Vehicle | Treatment Satisfaction Questionnaire for Medication Score | Effectiveness | 41.7 units on a scale | Standard Deviation 12.9 |
| LEO 124249 Vehicle | Treatment Satisfaction Questionnaire for Medication Score | Convenience | 54.6 units on a scale | Standard Deviation 21.8 |
| LEO 124249 Vehicle | Treatment Satisfaction Questionnaire for Medication Score | Side effects | 100.0 units on a scale | Standard Deviation 0 |