A Study to Evaluate the Potential of Tazarotene Foam to Cause a Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a
      phototoxic reaction when exposed to UV and VIS light on skin of healthy volunteers.
    

Detailed description: 
      This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to
      evaluate the potential of Tazarotene Foam 0.1% to induce a phototoxic reaction in healthy
      adult volunteers. Approximately 40 healthy, male and female, volunteer subjects aged 18 to 65
      years will be enrolled.

      Each subject will be exposed to three (3) sets of three (3) patches containing Tazarotene
      Foam, Vehicle Foam and a Blank Patch (no study product). Each patch set will be applied to
      randomized sites on the subject's back. Patch sets will be removed and evaluated after 24
      hours of exposure. The exposed patch sites will then be irradiated (exposed to light) and
      evaluated at 1 hour post irradiation and at 24, 48, and 72 hours.
    

Intervention name(s): Tazarotene Foam without irradiation; Tazarotene Foam with UVA and UVB irradiation; Tazarotene Foam with UVA, UVB, and visible light; Vehicle Foam without irradiation; Vehicle Foam with UVA and UVB irradiation; Vehicle Foam with UVA and UVB and visible light irradiation; No Treatment without irradiation; No Treatment with UVA and UVB irradiation; No Treatment with UVA and UVB and visible light irradiation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period.
This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.; Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.; Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.; Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.; Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.; Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.; Each subject will be exposed to a blank patch during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.; Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.; Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy volunteer study; phototoxicity