Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04773600 | Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II) | PHASE3 | COMPLETED | 683 | — | — | Feb 24, 2021 | Sep 29, 2022 | Oct 4, 2024 | 53 | United States, Canada |
The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity.
| Arm | Type | Description |
|---|---|---|
| Roflumilast Cream 0.15% | EXPERIMENTAL | Participants apply roflumilast cream 0.15% once daily (qd) for 4 weeks. |
| Vehicle Cream | PLACEBO_COMPARATOR | Participants apply vehicle cream qd for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Roflumilast Cream | DRUG | Roflumilast cream 0.15% for topical application |
| Vehicle cream | DRUG | Vehicle cream for topical application |
Inclusion Criteria: 1. Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws. 2. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites loc...