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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


Sponsor: ZARS Pharma Inc.

Current Primary Outcome: Response as assessed by Investigator Global Assessment (IGA) [ Time Frame: Baseline, Week 1, Week 2, Week 4 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subject's Global Impression of Change (SGIC) [ Time Frame: Week 4 (end-of-treatment) ]
  • Individual Primary Parameters of Hand Dermatitis [ Time Frame: Baseline, Week 1, Week 2, Week 4 ]
  • Signs or symptoms of hand dermatitis [ Time Frame: Baseline, Week 1, Week 2, Week 4 ]
  • Subject's self-assessment of overall hand disease [ Time Frame: Baseline, Week 4 ]
  • Study medication assessment [ Time Frame: Week 1, Week 2, Week 4 ]


Original Secondary Outcome: Same as current

Information By: ZARS Pharma Inc.

Dates:
Date Received: April 28, 2009
Date Started: April 2009
Date Completion:
Last Updated: March 14, 2012
Last Verified: March 2012