The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is safe and effective in the treatment of hand dermatitis.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
topical gel; once daily (nightly); total duration: 4 weeks
topical gel; once daily (nightly); total duration: 4 weeks
Therapeutics Clinical Research
San Diego, California, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
DermResearch Inc.
Austin, Texas, United States
Response as assessed by Investigator Global Assessment (IGA)
Time frame: Baseline, Week 1, Week 2, Week 4
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.