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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01182636 | Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris | PHASE1 | COMPLETED | 601 | — | — | Jul 1, 2007 | Apr 1, 2008 | Nov 24, 2010 | 22 | United States, Belize |
Per Protocol Population (PPP) was assessed for the mean percent reduction compared to baseline in non-nodular lesion count (papules and pustules) at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
Per Protocol Population (PPP) was assessed for the mean percent reduction in non-inflamed lesion count (open and closed comedones) compared with baseline at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
All 601 patients randomized and dispensed study drug were included in the safety analysis. The frequency, severity, and relationship to the study drug for adverse events in each treatment group were used to compare the safety of the study medications.
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Adapalene Topical Gel, 0.1% |
| Reference Listed Drug | ACTIVE_COMPARATOR | Differin® (adapalene 0.1%) Topical Gel |
| Placebo | PLACEBO_COMPARATOR | Gel base only |
| Name | Type | Description |
|---|---|---|
| Adapalene | DRUG | 0.1% Topical Gel |
| Differin® | DRUG | 0.1% Topical Gel |
| Placebo | DRUG | Gel Base |
Inclusion Criteria: * Male or non-pregnant, non-lactating female, 12-40 years of age inclusive. * Signed informed consent form, which meets all the criteria of the current FDA regulations. For patients under the age of majority in the state they are enrolled, the patient's parent or legal guardian ...