Hydrogel Patch for the Treatment of Eczema
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|ClinicalTrials.gov Identifier: NCT00924508|
Recruitment Status : Terminated (Loss of Funding)
First Posted : June 19, 2009
Results First Posted : November 25, 2013
Last Update Posted : January 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Eczema||Device: hydrogel patch Drug: Triamcinolone (TAC) 0.1% cream||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Compare the Efficacy of Triamcinolone 0.1% Cream Occluded With Hydrogel Patch to Triamcinolone 0.1% Cream Without Occlusion in the Treatment of Eczema|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||July 2012|
Experimental: Patch + cream, patch alone, cream alone
This is a single arm study. Each subject will have 3 target lesions; one treated with TAC 0.1% cream and hydrogel patch (occlusion), the second treated with cream alone, and the third treated with occlusion alone.
Device: hydrogel patch
occlusion of eczema with a hydrogel patch composed of an adhesive, thin, flexible, hydrogel layer on an impermeable urethane surface.
Drug: Triamcinolone (TAC) 0.1% cream
Triamcinolone Acetonide (triamcinolone acetonide cream) is a topical corticosteroid used as anti-inflammatory and antipruritic agent. Each gram of TAC Cream USP, 0.1% contains 1 mg Triamcinolone Acetonide (triamcinolone acetonide cream) in a cream base consisting of cetyl alcohol, glyceryl monostearate, cetyl esters wax, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water.
- Change in Disease Severity: Percent Change in Mean EASI Score [ Time Frame: Baseline, 6 weeks ]Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.
- Number of Adverse Events Associated With Treatment [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924508
|United States, California|
|UCSF Psoriasis Skin and Treatment Center|
|San Francisco, California, United States, 94118|
|Principal Investigator:||John Koo, MD||University of California, San Francisco|