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Tazarotene Foam without irradiation · 1 trial · 1 indication
Evaluation of patch sites for inflammatory skin responses and superficial effects following 24 hours of exposure and following irradiation on Day 2
| Arm | Type | Description |
|---|---|---|
| Tazarotene Foam without irradiation | EXPERIMENTAL | Subjects will be exposed to Tazarotene Foam Patch without irradiation |
| Tazarotene Foam with UVA and UVB irradiation | EXPERIMENTAL | Subjects will be exposed to Tazarotene Foam Patch with UVA and UVB irradiation |
| Tazarotene Foam with UVA , UVB, and visible light irradiation | EXPERIMENTAL | Subjects will be exposed to Tazarotene Foam with UVA and UVB and visible light irradiation |
| Vehicle Foam without irradiation | PLACEBO_COMPARATOR | Subjects will be exposed to Vehicle Foam Patch without irradiation |
| Vehicle Foam with UVA and UVB irradiation | PLACEBO_COMPARATOR | Subjects will be exposed to Vehicle Foam Patch with UVA and UVB irradiation |
| Vehicle Foam with UVA and UVB and visible light irradiation | PLACEBO_COMPARATOR | Subjects will be exposed to Vehicle Foam Patch with UVA and UVB and visible light irradiation |
| No Treatment without irradiation | SHAM_COMPARATOR | Subjects will be exposed to a Blank Patch without irradiation |
| No Treatment with UVA and UVB irradiation | SHAM_COMPARATOR | Subjects will be exposed to a Blank Patch with UVA and UVB irradiation |
| No Treatment with UVA and UVB and visible light irradiation | SHAM_COMPARATOR | Subjects will be exposed to a Blank Patch with UVA and UVB and visible light irradiation |
| Name | Type | Description |
|---|---|---|
| Tazarotene Foam without irradiation | DRUG | 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. |
| Tazarotene Foam with UVA and UVB irradiation | DRUG | 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. |
| Tazarotene Foam with UVA, UVB, and visible light | DRUG | 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. |
| Vehicle Foam without irradiation | DRUG | 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. |
| Vehicle Foam with UVA and UVB irradiation | DRUG | 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. |
| Vehicle Foam with UVA and UVB and visible light irradiation | DRUG | 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. |
| No Treatment without irradiation | DRUG | 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. |
| No Treatment with UVA and UVB irradiation | DRUG | 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. |
| No Treatment with UVA and UVB and visible light irradiation | DRUG | 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. |
Inclusion Criteria: * Capable of understanding and willing to provide signed and dated written voluntary informed consent and Health Information Portability and Accountability Act (HIPAA) authorization before any protocol-specific procedures are performed. * Male or female aged 18 to 65 years, incl...
Tazarotene Foam without irradiation is an investigational small molecule formulation being developed by GSK plc for acne vulgaris. It is a topical foam product studied in a Phase 1 trial. The name distinguishes this formulation from versions of tazarotene foam evaluated in combination with light exposure.
Tazarotene Foam without irradiation is being studied for the treatment of acne vulgaris, a common inflammatory skin condition. The development program focuses on dermatology. It is investigational and has not been approved for commercial use based on the available development information.
GSK plc, which trades under the ticker GSK, is the developer of Tazarotene Foam without irradiation. The company is advancing the asset for acne vulgaris within its dermatology portfolio.
Tazarotene Foam without irradiation is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA.
Tazarotene Foam without irradiation has been evaluated in one completed Phase 1 trial, NCT01115322. That study assessed the potential of tazarotene foam to cause a skin reaction when applied and exposed to light in 38 healthy volunteers in the United States. It was randomized and placebo-controlled.