Safety and Efficacy Study of Triamcinolone Acetonide DuraPeel to Treat Hand Dermatitis
Summary
The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is safe and effective in the treatment of hand dermatitis.
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Hand Dermatoses
Intervention
Triamcinolone Acetonide (TAC) DuraPeel, Placebo DuraPeel
Location
Therapeutics Clinical Research
San Diego
California
United States
92123
Status
Completed
Source
ZARS Pharma Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00890968
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Triamcinolone Acetonide
An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.
Hand Deformities, Acquired
Deformities of the hand, or a part of the hand, acquired after birth as the result of injury or disease.
Hand Deformities
Alterations or deviations from normal shape or size which result in a disfigurement of the hand.
Wrestling
A sport consisting of hand-to-hand combat between two unarmed contestants seeking to pin or press each other's shoulders to the ground.
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