Trial Outcomes & Findings for LEO 124249 Ointment in the Treatment of Alopecia Areata (NCT NCT02561585)
NCT ID: NCT02561585
Last Updated: 2025-03-06
Results Overview
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.
COMPLETED
PHASE2
40 participants
From baseline (Day 1) to Week 12 (Day 84)
2025-03-06
Participant Flow
Date of First Subject First Visit: 02-Feb-2016 Date of Last Subject Last Visit: 06-Dec-2016
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.
Participant milestones
| Measure |
LEO 124249
LEO 124249 ointment 30 mg/g twice daily
|
LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
11
|
|
Overall Study
COMPLETED
|
17
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LEO 124249 Ointment in the Treatment of Alopecia Areata
Baseline characteristics by cohort
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
LEO 124249
n=17 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=6 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Change in Severity of Alopecia Areata Tool (SALT) Score
|
-3.8 units on a scale
Standard Deviation 9.3
|
-3.4 units on a scale
Standard Deviation 17.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Summary of Absolute SALT Score
Baseline (Day 1)
|
67.2 units on a scale
Standard Deviation 25.1
|
74.4 units on a scale
Standard Deviation 24.3
|
—
|
—
|
|
Summary of Absolute SALT Score
Week 4 (Day 28)
|
63.1 units on a scale
Standard Deviation 26.7
|
71.0 units on a scale
Standard Deviation 25.9
|
—
|
—
|
|
Summary of Absolute SALT Score
Week 8 (Day 56)
|
62.7 units on a scale
Standard Deviation 27.5
|
68.6 units on a scale
Standard Deviation 31.2
|
—
|
—
|
|
Summary of Absolute SALT Score
Week 12 (Day 84)
|
61.2 units on a scale
Standard Deviation 28.9
|
66.4 units on a scale
Standard Deviation 38.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Summary of Change in SALT Score
Baseline (Day 1) to Week 4 (Day 28)
|
-2.2 units on a scale
Standard Deviation 4.4
|
0.0 units on a scale
Standard Deviation 1.3
|
—
|
—
|
|
Summary of Change in SALT Score
Baseline (Day 1) to Week 8 (Day 56)
|
-2.5 units on a scale
Standard Deviation 7.3
|
-1.5 units on a scale
Standard Deviation 9.6
|
—
|
—
|
|
Summary of Change in SALT Score
Baseline (Day 1) to Week 12 (Day 84)
|
-3.8 units on a scale
Standard Deviation 9.3
|
-3.4 units on a scale
Standard Deviation 17.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Summary of Relative Change in SALT Score
Baseline (Day 1) to Week 4 (Day 28)
|
-4.6 percentage change
Standard Deviation 9.0
|
-0.3 percentage change
Standard Deviation 2.3
|
—
|
—
|
|
Summary of Relative Change in SALT Score
Baseline (Day 1) to Week 8 (Day 56)
|
-5.6 percentage change
Standard Deviation 17.8
|
-5.3 percentage change
Standard Deviation 16.9
|
—
|
—
|
|
Summary of Relative Change in SALT Score
Baseline (Day 1) to Week 12 (Day 84)
|
-7.7 percentage change
Standard Deviation 22.3
|
-9.1 percentage change
Standard Deviation 32.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1)
Outcome measures
| Measure |
LEO 124249
n=17 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=6 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Percentage of Patients Who Achieve 50% Improvement in the SALT Score
Yes
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Percentage of Patients Who Achieve 50% Improvement in the SALT Score
No
|
15 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Hair length measured in millimeters.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Hair Length
Week 4 (Day 28)
|
12.7 mm
Standard Deviation 17.0
|
5.6 mm
Standard Deviation 8.4
|
—
|
—
|
|
Hair Length
Week 8 (Day 56)
|
18.2 mm
Standard Deviation 21.7
|
10.3 mm
Standard Deviation 16.9
|
—
|
—
|
|
Hair Length
Week 12 (Day 84)
|
25.1 mm
Standard Deviation 31.8
|
16.3 mm
Standard Deviation 23.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Change in hair length measured in millimeters per day.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Hair Growth Rate
Week 4 (Day 28)
|
0.4 mm/day
Standard Deviation 0.7
|
0.1 mm/day
Standard Deviation 0.2
|
—
|
—
|
|
Hair Growth Rate
Week 8 (Day 56)
|
0.2 mm/day
Standard Deviation 0.3
|
0.1 mm/day
Standard Deviation 0.5
|
—
|
—
|
|
Hair Growth Rate
Week 12 (Day 84)
|
0.3 mm/day
Standard Deviation 0.8
|
0.1 mm/day
Standard Deviation 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Relative Hair Thickness
Week 4 (Day 28) · Much thinner
|
10 Participants
|
1 Participants
|
—
|
—
|
|
Relative Hair Thickness
Week 4 (Day 28) · Slightly thinner
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Relative Hair Thickness
Week 4 (Day 28) · Same thickness
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Relative Hair Thickness
Week 8 (Day 56) · Much thinner
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Relative Hair Thickness
Week 8 (Day 56) · Slightly thinner
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Relative Hair Thickness
Week 8 (Day 56) · Same thickness
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Relative Hair Thickness
Week 12 (Day 84) · Much thinner
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Relative Hair Thickness
Week 12 (Day 84) · Slightly thinner
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Relative Hair Thickness
Week 12 (Day 84) · Same thickness
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Hair Type
Week 4 (Day 28) · Terminal hair
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Hair Type
Week 4 (Day 28) · Velus hair
|
9 Participants
|
2 Participants
|
—
|
—
|
|
Hair Type
Week 8 (Day 56) · Terminal hair
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Hair Type
Week 8 (Day 56) · Velus hair
|
9 Participants
|
1 Participants
|
—
|
—
|
|
Hair Type
Week 12 (Day 84) · Terminal hair
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Hair Type
Week 12 (Day 84) · Velus hair
|
6 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Hair Color
Week 4 (Day 28) · Black
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Hair Color
Week 4 (Day 28) · Blond
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Hair Color
Week 4 (Day 28) · Brown
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 4 (Day 28) · Gray
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 4 (Day 28) · Red
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 4 (Day 28) · White
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Hair Color
Week 8 (Day 56) · Black
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Hair Color
Week 8 (Day 56) · Blond
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 8 (Day 56) · Brown
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 8 (Day 56) · Gray
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Hair Color
Week 8 (Day 56) · Red
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 8 (Day 56) · White
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Hair Color
Week 12 (Day 84) · Black
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 12 (Day 84) · Blond
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 12 (Day 84) · Brown
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 12 (Day 84) · Gray
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 12 (Day 84) · Red
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Hair Color
Week 12 (Day 84) · White
|
4 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Based on standardized photographs
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 12 (Day 84) · Much worse
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 4 (Day 28) · Much worse
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 4 (Day 28) · Moderately worse
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 4 (Day 28) · Slightly worse
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 4 (Day 28) · Unchanged
|
15 Participants
|
8 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 4 (Day 28) · Slightly improved
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 4 (Day 28) · Moderately improved
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 4 (Day 28) · Much improved
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 8 (Day 56) · Much worse
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 8 (Day 56) · Moderately worse
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 8 (Day 56) · Slightly worse
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 8 (Day 56) · Unchanged
|
14 Participants
|
5 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 8 (Day 56) · Slightly improved
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 8 (Day 56) · Moderately improved
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 8 (Day 56) · Much improved
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 12 (Day 84) · Moderately worse
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 12 (Day 84) · Slightly worse
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 12 (Day 84) · Unchanged
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 12 (Day 84) · Slightly improved
|
5 Participants
|
0 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 12 (Day 84) · Moderately improved
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Week 12 (Day 84) · Much improved
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Participant's Global Assessment of Hair Regrowth
Week 8 (Day 56) · 100% of regrowth
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 4 (Day 28) · No regrowth
|
8 Participants
|
6 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 4 (Day 28) · <25% of regrowth
|
8 Participants
|
3 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 4 (Day 28) · 25%-49% of regrowth
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 4 (Day 28) · 50%-74% of regrowth
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 4 (Day 28) · 75%-99% of regrowth
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 4 (Day 28) · 100% of regrowth
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 8 (Day 56) · No regrowth
|
8 Participants
|
5 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 8 (Day 56) · <25% of regrowth
|
8 Participants
|
1 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 8 (Day 56) · 25%-49% of regrowth
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 8 (Day 56) · 50%-74% of regrowth
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 8 (Day 56) · 75%-99% of regrowth
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 12 (Day 84) · No regrowth
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 12 (Day 84) · <25% of regrowth
|
8 Participants
|
1 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 12 (Day 84) · 25%-49% of regrowth
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 12 (Day 84) · 50%-74% of regrowth
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 12 (Day 84) · 75%-99% of regrowth
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Participant's Global Assessment of Hair Regrowth
Week 12 (Day 84) · 100% of regrowth
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
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
|
24.3 units on a scale
Standard Deviation 5.5
|
25.5 units on a scale
Standard Deviation 4.4
|
23.7 units on a scale
Standard Deviation 7.3
|
|
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
|
17.5 units on a scale
Standard Deviation 6.7
|
18.7 units on a scale
Standard Deviation 7.2
|
16.8 units on a scale
Standard Deviation 7.5
|
|
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
|
8.4 units on a scale
Standard Deviation 2.2
|
6.9 units on a scale
Standard Deviation 2.3
|
7.7 units on a scale
Standard Deviation 2.7
|
|
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
|
50.2 units on a scale
Standard Deviation 11.1
|
51.1 units on a scale
Standard Deviation 12.5
|
48.2 units on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
LEO 124249
n=20 Participants
LEO 124249 ointment 30 mg/g twice daily application
|
LEO 124249 Vehicle
n=11 Participants
LEO 124249 ointment vehicle twice daily application
|
Week 12: LEO 124249
LEO 124249 ointment 30 mg/g twice daily application
|
Week 12: LEO 124249 Vehicle
LEO 124249 ointment vehicle twice daily application
|
|---|---|---|---|---|
|
Treatment Satisfaction Questionnaire for Medication Score
Effectiveness
|
28.9 units on a scale
Standard Deviation 23.2
|
41.7 units on a scale
Standard Deviation 12.9
|
—
|
—
|
|
Treatment Satisfaction Questionnaire for Medication Score
Side effects
|
94.5 units on a scale
Standard Deviation 15.1
|
100.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
|
Treatment Satisfaction Questionnaire for Medication Score
Convenience
|
52.3 units on a scale
Standard Deviation 17.7
|
54.6 units on a scale
Standard Deviation 21.8
|
—
|
—
|
|
Treatment Satisfaction Questionnaire for Medication Score
Global satisfaction
|
40.7 units on a scale
Standard Deviation 22.6
|
47.2 units on a scale
Standard Deviation 22.8
|
—
|
—
|
Adverse Events
LEO 124249
LEO 124249 Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LEO 124249
n=20 participants at risk
LEO 124249 ointment 30 mg/g twice daily
|
LEO 124249 Vehicle
n=11 participants at risk
LEO 124249 ointment vehicle twice daily
|
|---|---|---|
|
Infections and infestations
Folliculitis
|
10.0%
2/20 • Number of events 2 • 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.
|
0.00%
0/11 • 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.
|
|
Infections and infestations
Conjunctivitis
|
5.0%
1/20 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.0%
1/20 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place