NCT00890968

Safety and Efficacy Study of Triamcinolone Acetonide DuraPeel to Treat Hand Dermatitis

A Multi-Center Randomized, Double-Blind, Placebo Controlled, Parallel Group Comparison Study of Once Daily Triamcinolone Acetonide 0.5% DuraPeel™ Versus Placebo DuraPeel in the Treatment of Hand Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: ZARS Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is safe and effective in the treatment of hand dermatitis.

Detailed description

Triamcinolone acetonide is a commonly used, safe, and effective topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. However, the effectiveness of topical agents such as creams or ointments is limited by patients' routine activities using bare hands that may remove the topical agent from the hands. The use of a topical corticosteroid in a vehicle that allows the product to remain in contact with the skin and is not susceptible to inadvertent removal would be beneficial. The DuraPeel membrane is expected to optimize exposure to the steroid by remaining on the treatment area for a prolonged period of time. This study is designed to evaluate the efficacy and safety of Triamcinolone Acetonide 0.5% DuraPeel. Eligible subjects will receive Triamcinolone Acetonide 0.5% DuraPeel or Placebo DuraPeel. The study duration will be approximately 4 weeks.

Conditions

• Hand Dermatoses

Interventions

Type	Name	Description
DRUG	Triamcinolone Acetonide (TAC) DuraPeel	topical gel; once daily (nightly); total duration: 4 weeks
DRUG	Placebo DuraPeel	topical gel; once daily (nightly); total duration: 4 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2009-04-30
• Last updated: 2012-03-16

Locations

3 sites across 1 country: United States