Trial Outcomes & Findings for Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301) (NCT NCT03002571)
NCT ID: NCT03002571
Last Updated: 2023-05-08
Results Overview
Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.
COMPLETED
PHASE3
338 participants
Baseline to Week 6
2023-05-08
Participant Flow
Participant milestones
| Measure |
IDP-124 Lotion
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
IDP-124 Vehicle Lotion, twice-daily application
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
113
|
|
Overall Study
COMPLETED
|
202
|
99
|
|
Overall Study
NOT COMPLETED
|
22
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)
Baseline characteristics by cohort
| Measure |
IDP-124 Lotion
n=224 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=113 Participants
IDP-124 Vehicle Lotion, twice-daily application
|
Total
n=337 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 20.16 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 19.92 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 20.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
89 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.
Outcome measures
| Measure |
IDP-124 Lotion
n=224 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=113 Participants
IDP-124 Vehicle Lotion, twice-daily application
|
|---|---|---|
|
Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to "Clear" or "Almost Clear"
|
42.95 percentage of participants
|
27.96 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 10Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores.
Outcome measures
| Measure |
IDP-124 Lotion
n=224 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=113 Participants
IDP-124 Vehicle Lotion, twice-daily application
|
|---|---|---|
|
Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to "Clear" or "Almost Clear"
Week 10
|
35.71 percentage of participants
|
24.96 percentage of participants
|
|
Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to "Clear" or "Almost Clear"
Week 2
|
9.82 percentage of participants
|
5.31 percentage of participants
|
|
Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to "Clear" or "Almost Clear"
Week 4
|
26.25 percentage of participants
|
16.46 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 10EASI 75 is defined as at least a 75% reduction in the Eczema Area Severity Index (EASI) score from Baseline. EASI is composite score based on the evaluated severity of 4 key signs of AD (i.e., erythema, infiltration/papulation, excoriation and lichenification), and the extent of disease in each of the 4 body regions (i.e., head/neck, trunk, upper limbs, and lower limbs). The area of involvement (affected by inflammation, not including dry skin) of each of the 4 body regions is determined and represented by a numeric coded value based on a scale from 0 to 6. The 4 body regions are assessed separately for each sign/symptom, and the average degree of severity of each sign in each of the 4 body parts is assigned a score of 0 (none) to 3 (severe) on a scale that allows half-unit increments. The EASI score ranges from 0 to 72, with higher scores being worse.
Outcome measures
| Measure |
IDP-124 Lotion
n=224 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=113 Participants
IDP-124 Vehicle Lotion, twice-daily application
|
|---|---|---|
|
Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
Week 4
|
31.79 percentage of participants
|
26.55 percentage of participants
|
|
Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
Week 6
|
46.61 percentage of participants
|
37.35 percentage of participants
|
|
Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
Week 10
|
42.68 percentage of participants
|
33.10 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 2Pruritis was assessed on a 4-point scale with 0 (none) to 3 (severe) and higher scores being worse.
Outcome measures
| Measure |
IDP-124 Lotion
n=224 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=113 Participants
IDP-124 Vehicle Lotion, twice-daily application
|
|---|---|---|
|
Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to "None" or "Mild"
Week 1
|
41.20 percentage of participants
|
34.31 percentage of participants
|
|
Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to "None" or "Mild"
Week 2
|
51.34 percentage of participants
|
43.30 percentage of participants
|
Adverse Events
IDP-124 Lotion
IDP-124 Vehicle Lotion
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IDP-124 Lotion
n=224 participants at risk
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=113 participants at risk
IDP-124 Vehicle Lotion, twice-daily application
|
|---|---|---|
|
General disorders
Application site dermatitis
|
3.6%
8/224 • 10 weeks
|
5.3%
6/113 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor for details.
- Publication restrictions are in place
Restriction type: OTHER