NCT01114841

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tazarotene Foam	Patches containing Tazarotene Foam 0.1% will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours. There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge). These patches will then be evaluated at 24, 48, and 72 hours. There may be a second rest period and a second 48-hour patch application and evaluation, if required.
DRUG	Vehicle Foam	Patches containing Vehicle Foam will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours. There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge). These patches will then be evaluated at 24, 48, and 72 hours. There may be a second rest period and a second 48-hour patch application and evaluation, if required.

Timeline

• Start date: 2010-03-31
• Primary completion: 2010-06-26
• Completion: 2010-06-26
• First posted: 2010-05-03
• Last updated: 2017-06-14

Locations

1 site across 1 country: United States