Hand Dermatoses
Conditions
Keywords
hand dermatitis, hand eczema, triamcinolone acetonide
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 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.
Interventions
DRUGTriamcinolone Acetonide (TAC) DuraPeel
topical gel; once daily (nightly); total duration: 4 weeks
DRUGPlacebo DuraPeel
topical gel; once daily (nightly); total duration: 4 weeks
Sponsors
ZARS Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of stable chronic hand dermatitis (greater than 6 weeks duration) that is KOH-negative * Dermatitis of mild to moderate severity, as defined by an Investigator's Global Assessment (a score of 2 or 3 on the Target Hand) * Individual signs of hand dermatitis disease of at least mild scaling and mild erythema (a score of 2 or more on the Target Hand) * Written informed consent
Exclusion criteria
* Subject is female and is pregnant, lactating, or is planning to become pregnant during the study * Spontaneously improving or rapidly deteriorating hand dermatitis at the time of enrollment; subject may have history of waxing and waning disease in the past * History of hand dermatitis that has been shown to be unresponsive to super potent (Group 1) topical steroids * Concurrent flaring of inflammatory skin disease (e.g., atopic dermatitis or psoriasis) anywhere on the body outside the study areas * Bullous disorders or hand, foot, and mouth disease (HFMD); however, subjects with dyshidrotic hand dermatitis or pompholyx are allowed to participate provided they meet all other Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response as assessed by Investigator Global Assessment (IGA) | Baseline, Week 1, Week 2, Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Subject's Global Impression of Change (SGIC) | Week 4 (end-of-treatment) |
| Individual Primary Parameters of Hand Dermatitis | Baseline, Week 1, Week 2, Week 4 |
| Signs or symptoms of hand dermatitis | Baseline, Week 1, Week 2, Week 4 |
| Subject's self-assessment of overall hand disease | Baseline, Week 4 |
| Study medication assessment | Week 1, Week 2, Week 4 |
Countries
United States
Outcome results
None listed