Study: NCT01119651

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: Tazarotene (Patch application in Challenge Phase)
Description: 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.

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: Tazarotene (Patch application in Challenge Phase)
Description: 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.

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: Tazarotene (Patch application in Challenge Phase)
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tazarotene (Patch application in Challenge Phase)
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tazarotene (Patch application in Challenge Phase)
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tazarotene (Patch application in Challenge Phase)
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Tazarotene (Patch application in Challenge Phase)
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Tazarotene (Patch application in Challenge Phase)
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Tazarotene (Patch application in Challenge Phase)
Description: 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.