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 (NCT NCT03058783)
NCT ID: NCT03058783
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
328 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
|
216
|
110
|
|
Overall Study
COMPLETED
|
180
|
80
|
|
Overall Study
NOT COMPLETED
|
36
|
30
|
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
Baseline characteristics by cohort
| Measure |
IDP-124 Lotion
n=216 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=110 Participants
IDP-124 Vehicle Lotion, twice-daily application
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 20.21 • n=99 Participants
|
33.1 years
STANDARD_DEVIATION 20.46 • n=107 Participants
|
31.8 years
STANDARD_DEVIATION 20.28 • n=206 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
176 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
69 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
110 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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=216 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=110 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"
|
42.04 percentage of participants
|
32.73 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=216 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=110 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
|
31.67 percentage of participants
|
29.64 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
|
18.89 percentage of participants
|
8.73 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
|
28.70 percentage of participants
|
24.91 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=216 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=110 Participants
IDP-124 Vehicle Lotion, twice-daily application
|
|---|---|---|
|
Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
Week 4
|
33.61 percentage of participants
|
26.18 percentage of participants
|
|
Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
Week 6
|
46.11 percentage of participants
|
37.45 percentage of participants
|
|
Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
Week 10
|
43.24 percentage of participants
|
34.00 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=216 Participants
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=110 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
|
46.19 percentage of participants
|
37.41 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
|
52.76 percentage of participants
|
39.81 percentage of participants
|
Adverse Events
IDP-124 Lotion
IDP-124 Vehicle Lotion
Serious adverse events
| Measure |
IDP-124 Lotion
n=216 participants at risk
IDP-124 Lotion, twice-daily application
|
IDP-124 Vehicle Lotion
n=110 participants at risk
IDP-124 Vehicle Lotion, twice-daily application
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.46%
1/216 • 10 weeks
|
0.00%
0/110 • 10 weeks
|
|
Infections and infestations
Sepsis
|
0.46%
1/216 • 10 weeks
|
0.00%
0/110 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.46%
1/216 • 10 weeks
|
0.00%
0/110 • 10 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor for details.
- Publication restrictions are in place
Restriction type: OTHER