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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01826461 | An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis | PHASE2 | COMPLETED | 151 | — | — | Mar 1, 2013 | Dec 1, 2013 | May 29, 2014 | 9 | United States |
Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe.
| Arm | Type | Description |
|---|---|---|
| PDI-192 Foam, 0.1% | EXPERIMENTAL | topical foam, 0.1% concentration, twice daily |
| PDI-192 Foam, 0.15% | EXPERIMENTAL | topical foam, 0.15% concentration, twice daily |
| Vehicle Foam | PLACEBO_COMPARATOR | topical foam, 0% concentration, twice daily |
| Name | Type | Description |
|---|---|---|
| PDI-192 | DRUG | - |
| Vehicle | DRUG | - |
Inclusion Criteria: * Subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis. * Subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to stu...