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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01915758 | W0265-104: A Single-Center, Evaluator-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial Evaluating the Photoallergic Potential of Topically Applied Clindamycin Phosphate 1.0% and Tretinoin 0.025% (CT Gel) in Healthy Volunteers | PHASE1 | COMPLETED | 64 | — | — | Nov 21, 2008 | Feb 20, 2009 | Jul 18, 2017 | - | — |
In cases where the patch area is larger than the irradiated area, only the irradiated areas will be scored unless reactions outside the irradiated area exhibit unusual responses. Scores represent the presence of clinically significant effects on at least 25% of the test site. Questionable, barely perceptible, or minimal reactions involving less than 25% of the test site will not be considered significant.
| Arm | Type | Description |
|---|---|---|
| occlusive patch 200 uL of clindamycin1%/tretinoin0.025% Gel | EXPERIMENTAL | occlusive patch 200 uL of clindamycin1%/tretinoin0.025% Gel |
| occlusive patch 200uL of vehicle gel | PLACEBO_COMPARATOR | occlusive patch 200uL of vehicle gel |
| Name | Type | Description |
|---|---|---|
| clindamycin1%/tretinoin 0.025% gel | DRUG | clindamycin1%/tretinoin 0.025% gel |
| vehicle gel | DRUG | vehicle gel |
Inclusion Criteria: * The capability of understanding and providing signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed. * Male or female subjects aged from 18 to 65 years, inclusive, at ti...