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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone Acetonide (TAC) DuraPeel | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide (TAC) DuraPeel | Drug | topical gel; once daily (nightly); total duration: 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response as assessed by Investigator Global Assessment (IGA) | Baseline, Week 1, Week 2, Week 4 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Piacquadio, MD | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States | ||
| Michigan Center for Skin Care Research |
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| ID | Term |
|---|---|
| D006229 | Hand Dermatoses |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo DuraPeel | Drug | topical gel; once daily (nightly); total duration: 4 weeks |
|
| 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 |
| Clinton Township |
| Michigan |
| 48038 |
| United States |
| DermResearch Inc. | Austin | Texas | 78759 | United States |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |