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
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): CT Gel (clindamycin 1% and tretinoin 0.025%); Vehicle gel patch; Blank patch
Intervention type(s): Drug; Other; Other
Intervention description(s): Three CT Gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures.; Three vehicle gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 2. Vehicle gel contained the identical ingredients and packaging as CT Gel but without the active ingredients. All vehicle gel used during the study was from batch ZLU C.; Three blank patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 3. Occlusive patches consisted of a non-woven cotton pad (Webril [approximately 2 cm x 2 cm]) covered and secured on all sides by an occlusive hypoallergenic tape (approximately 4 cm x 4 cm).
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other