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Tazarotene · 2 trials · 1 indication
Patch site evaluations for signs of inflammatory skin responses and superficial effect
| 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 & UVA/UVB/visible light | EXPERIMENTAL | Subjects will be exposed to Tazarotene Foam Patch 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 & UVB visible light irradiation | PLACEBO_COMPARATOR | Subjects will be exposed to Vehicle Foam Patch with UVA and UVB and visible light irradiation |
| Blank patch without irradiation | SHAM_COMPARATOR | Subjects will be exposed to blank patch without irradiation, |
| Blank patch with UVA and UVB irradiation | SHAM_COMPARATOR | Subjects will be exposed to blank patch with UVA and UVB irradiation |
| Blank Patch with UVA & UVB visible light irradiation | SHAM_COMPARATOR | Subjects will be exposed to Blank Patch with UVA and UVB and visible light irradiation |
| 1 | EXPERIMENTAL | Tazarotene foam 0.1% |
| 2 | ACTIVE_COMPARATOR | Tazaroc Gel 0.1% |
| Name | Type | Description |
|---|---|---|
| Tazarotene (Patch application in Challenge Phase) | DRUG | There are 2 phases in this study. The induction phase will include 6 days of patch application to the subject's back. Patches will be removed daily and irradiated. Patch applications will be placed on the same sites, unless a strong reaction is observed. The induction phase will be followed by a rest period followed by the Challenge Phase which consists of a 24-hr application of 3 sets of 3 patches (Set C, Set D, and Set E) applied to naïve sites on the subject's back. Each set of patches will consist of a tazarotene foam patch, a vehicle foam patch, and a blank patch. After 24 hrs, Set D patch sites will be evaluated and irradiated with UVA/UVB light. Set C patch sites will be evaluated and irradiated with UVA, UVB light and visible light. Set E patch sites will be evaluated \& will serve as nonirradiated controls. Patch sites will be evaluated 1 hr after patch removal and during follow up visits at 24 hrs, 48 hrs, and 72 hrs after removal of the final patch in Set E. |
| Tazarotene | DRUG | Topical Tazarotene foam applied daily for 22 days. |
| Tazaroc Gel | DRUG | Topical tazarotene gel applied daily for 22 days. |
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 is an investigational small molecule being studied for the treatment of Acne Vulgaris. It is developed by GSK plc (GSK) and is currently in Phase 1 clinical development. The drug is being evaluated as a topical foam formulation for patients with acne.
Tazarotene is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and bioavailability in patients with Acne Vulgaris.
Tazarotene is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 89 participants enrolled. The drug is investigational and has not been approved by regulatory authorities.
Tazarotene has been studied in two completed Phase 1 trials. NCT01019603 evaluated the bioavailability of Tazarotene Foam, 0.1%, compared to Tazorac Gel, 0.1%, in 30 subjects with Acne Vulgaris. NCT01119651 assessed the allergic reaction potential of the foam in 59 healthy volunteers.
Tazarotene is a small molecule developed for topical use in Acne Vulgaris. The clinical trials focus on its bioavailability and skin tolerability, including potential allergic reactions when exposed to light. The specific molecular target has not been disclosed in the trial information.
Tazarotene is being studied as a foam formulation, and one clinical trial compares it directly to Tazorac Gel, 0.1%. The trial evaluates the bioavailability of Tazarotene Foam, 0.1%, against Tazorac Gel, 0.1%, in subjects with Acne Vulgaris.