W0265-103: A Single-Center, Evaluator-Blinded, Randomized, Placebo Controlled, Phase 1 Clinical Trial Evaluating The Phototoxic Potential Of Topically Applied Clindamycin 1.0% - Tretinoin 0.025% Gel (Ct Gel) In Healthy Volunteers

Summary

Clindamycin 1.0% - tretinoin 0.025% gel (CT Gel) is a reformulation of VELAC Gel that contains the same active ingredients (clindamycin 1.0% and tretinoin 0.025%) in a modified vehicle. This was a single-center, evaluator-blinded, randomized, placebo (vehicle)-controlled phase 1 study to evaluate the phototoxic potential of CT Gel using 24 hour single applications of 3 sets of 3 study patches. The study expected to enroll approximately 40 healthy adult volunteers. Each set of study patches consisted of a CT Gel patch, a vehicle gel patch, and a blank patch (did not contain CT Gel or vehicle gel). After concurrent 24-hour single applications of all 9 patches, 1 set of patches (set A) was removed, and those sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) and 0.75 minimal erythema dose (MED) with UVA/ultraviolet B light (UVB). The second set of patches (set B) was removed, and those sites were irradiated with 16 joules/cm2 of UVA, 0.75 MED with UVB/UVA, followed by 15 joules/cm2 of visible light (VIS). The third set of patches (set C) was then removed, and those sites served as a non irradiated control. Inflammatory responses and other cutaneous effects were scored 1 hour after patch removal and during follow-up visits at 24, 48, and 72 hours after patch removal.

Timeline

Start

2008-12-08

Primary completion

2008-12-19

Completion

2008-12-19

Drugs

Indications