NCT01112787

A Study to Evaluate the Irritation Potential of Tazarotene Foam on Skin in Healthy Volunteers

A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled, Study To Evaluate The Cumulative Irritation Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the irritation level of tazarotene foam after 21 days of exposure on the 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 to induce cutaneous irritation using a 21 day cumulative irritation assay in healthy adult volunteers. Approximately 40 healthy male and female volunteer subjects aged 18 to 65 years will be enrolled. All subjects will be exposed to patches containing tazarotene foam, vehicle foam, sodium lauryl sulfate 0.5% (positive control), and distilled water (negative control). Each set of patches will be applied to the same randomized sites once daily for 21 days; patches will be removed after 24 ±1 hours and the patch sites will be evaluated for signs inflammatory skin responses (eg, erythema, edema, papules) and superficial effects.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tazarotene Foam	Tazarotene Foam
DRUG	Vehicle Foam	Vehicle Foam
DRUG	Sodium Laural Sulfate	Sodium Laural Sulfate
DRUG	Distilled Water	Distilled Water

Timeline

• Start date: 2010-03-26
• Primary completion: 2010-04-26
• Completion: 2010-04-26
• First posted: 2010-04-28
• Last updated: 2017-06-20

Locations

1 site across 1 country: United States