A Study To Evaluate The Contact Sensitization Potential Of Tazarotene Foam On Skin In Healthy Volunteers

Acne Vulgaris Clinical Trial

Official title: A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled, Study To Evaluate The Contact Sensitization Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers

Status Completed

Clinical Trial Summary

This study will assess the potential of tazarotene foam to cause sensitization during a 48 hour challenge following 21 days of exposure on the skin of healthy volunteers.

Clinical Trial Description

This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to evaluate the potential of tazarotene foam 0.1% to induce contact sensitization following repeated exposure under maximal stress conditions in healthy adult volunteers. Approximately 240 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.

All subjects will be exposed to patches containing tazarotene foam and vehicle foam. Inflammatory skin responses (eg, erythema, edema, papules) or superficial effects at patch sites will be visually assessed and scored according to the corresponding grading scales.

The study duration will be 6 weeks or 9 weeks and will consist of the following phases: 3 week Induction, 2 week Rest, and 1 week Challenge, and if indicated, a second 2 week Rest and 1 week Repeat Challenge. ;

Related Conditions & MeSH terms

• Acne Vulgaris

• NCT number: NCT01114841
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2010
• Completion date: June 26, 2010