Trial Outcomes & Findings for Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED) (NCT NCT04845620)
NCT ID: NCT04845620
Last Updated: 2025-12-23
Results Overview
The percentage of participants with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
COMPLETED
PHASE3
652 participants
Week 4
2025-12-23
Participant Flow
This study was conducted at 109 centers in the United States, Canada, and Poland.
Participant milestones
| Measure |
Roflumilast Cream 0.05%
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
437
|
215
|
|
Overall Study
COMPLETED
|
410
|
192
|
|
Overall Study
NOT COMPLETED
|
27
|
23
|
Reasons for withdrawal
| Measure |
Roflumilast Cream 0.05%
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
10
|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Lack of Efficacy
|
4
|
4
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
Baseline characteristics by cohort
| Measure |
Roflumilast Cream 0.05%
n=437 Participants
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=215 Participants
Participants applied vehicle cream qd for 4 weeks.
|
Total
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.3 years
STANDARD_DEVIATION 1.09 • n=68 Participants
|
3.2 years
STANDARD_DEVIATION 1.10 • n=4 Participants
|
3.3 years
STANDARD_DEVIATION 1.09 • n=219 Participants
|
|
Sex: Female, Male
Female
|
211 Participants
n=68 Participants
|
99 Participants
n=4 Participants
|
310 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
226 Participants
n=68 Participants
|
116 Participants
n=4 Participants
|
342 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
82 Participants
n=68 Participants
|
31 Participants
n=4 Participants
|
113 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
352 Participants
n=68 Participants
|
184 Participants
n=4 Participants
|
536 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=219 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Asian
|
37 Participants
n=68 Participants
|
17 Participants
n=4 Participants
|
54 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Black or African American
|
68 Participants
n=68 Participants
|
32 Participants
n=4 Participants
|
100 Participants
n=219 Participants
|
|
Race (NIH/OMB)
White
|
295 Participants
n=68 Participants
|
156 Participants
n=4 Participants
|
451 Participants
n=219 Participants
|
|
Race (NIH/OMB)
More than one race
|
28 Participants
n=68 Participants
|
4 Participants
n=4 Participants
|
32 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=68 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis.
The percentage of participants with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
Outcome measures
| Measure |
Roflumilast Cream 0.05%
n=436 Participants
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=215 Participants
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4
|
25.4 percentage of participants
Interval 20.95 to 30.34
|
10.7 percentage of participants
Interval 6.77 to 16.45
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants with a baseline vIGA score of 'moderate' are included.
The percentage of participants with vIGA-AD success at Week 4 who had 'moderate' vIGA-AD score (vIGA score of 3) at baseline is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline in participants with moderate vIGA-AD baseline.
Outcome measures
| Measure |
Roflumilast Cream 0.05%
n=333 Participants
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=171 Participants
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD
|
27.7 percentage of participants
Interval 22.55 to 33.62
|
11.0 percentage of participants
Interval 6.67 to 17.73
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants are included, with the exception of 1 participant in the Roflumilast Cream 0.05% arm who was inadvertently treated prior to randomization and thus excluded from analysis.
The percentage of participants with a moderate baseline vIGA-AD score who achieved EASI-75 is presented. EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head {10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Outcome measures
| Measure |
Roflumilast Cream 0.05%
n=436 Participants
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=215 Participants
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA
|
39.4 percentage of participants
Interval 34.21 to 44.81
|
20.6 percentage of participants
Interval 15.06 to 27.55
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis.
The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 4 is presented. The vIGA is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Roflumilast Cream 0.05%
n=436 Participants
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=215 Participants
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear'
|
35.4 percentage of participants
Interval 30.39 to 40.66
|
14.6 percentage of participants
Interval 9.94 to 20.86
|
SECONDARY outcome
Timeframe: Week 2Population: All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis.
The percentage of participants with vIGA-AD success at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
Outcome measures
| Measure |
Roflumilast Cream 0.05%
n=436 Participants
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=215 Participants
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Achievement of vIGA-AD Success at Week 2
|
21.2 percentage of participants
Interval 17.13 to 25.98
|
6.8 percentage of participants
Interval 3.85 to 11.88
|
SECONDARY outcome
Timeframe: Week 1Population: All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis.
The percentage of participants with vIGA-AD success at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA-AD success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
Outcome measures
| Measure |
Roflumilast Cream 0.05%
n=436 Participants
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=215 Participants
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Achievement of vIGA-AD Success at Week 1
|
9.4 percentage of participants
Interval 6.72 to 13.02
|
0.9 percentage of participants
Interval 0.22 to 3.88
|
SECONDARY outcome
Timeframe: Week 2Population: All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis.
The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 2 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Roflumilast Cream 0.05%
n=436 Participants
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=215 Participants
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 2
|
30.4 percentage of participants
Interval 25.67 to 35.58
|
10.6 percentage of participants
Interval 6.74 to 16.42
|
SECONDARY outcome
Timeframe: Week 1Population: All randomized participants are included, 1 participant in the Roflumilast Cream 0.05% arm was inadvertently treated prior to randomization and thus excluded from analysis.
The percentage of participants with vIGA-AD score of 'clear' or 'almost clear' at Week 1 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Roflumilast Cream 0.05%
n=436 Participants
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=215 Participants
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 1
|
17.00 percentage of participants
Interval 13.32 to 21.37
|
3.7 percentage of participants
Interval 1.73 to 7.83
|
Adverse Events
Roflumilast Cream 0.05%
Vehicle Cream
Serious adverse events
| Measure |
Roflumilast Cream 0.05%
n=437 participants at risk
Participants applied roflumilast cream 0.05% qd for 4 weeks.
|
Vehicle Cream
n=215 participants at risk
Participants applied vehicle cream qd for 4 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.23%
1/437 • Up to ~6 weeks
|
0.00%
0/215 • Up to ~6 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Arcutis Medical Information
Arcutis Biotherapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
- Publication restrictions are in place
Restriction type: OTHER