Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01119651 | A Study to Evaluate the Potential of Tazarotene Foam to Cause an Allergic Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers. | PHASE1 | COMPLETED | 59 | — | — | Jun 14, 2010 | Jun 26, 2010 | Jun 14, 2017 | 1 | United States |
| NCT01019603 | A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris | PHASE1 | COMPLETED | 30 | — | — | Oct 12, 2009 | Dec 20, 2009 | Jun 23, 2017 | 1 | United States |
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...