Hydorgel Patch for the Treatment of Eczema
The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) used to treat eczema with hydrogel patch improves its efficacy. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Percentage of Patients with significant improvement of eczema [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Percentage of Adverse Events Associated with treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||July 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: TAC ointment with hydrogel, hydrogel alone, no treatment
This is a single arm study. Each subject will have 3 target lesions; one treated with ointment and occlusion, the second treated wtih ointment alone, and the third treated wtih occlusion alone.
Device: hydrogel and 0.1 % triamcinolone ointment
occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, occlusion alone, and ointment alone
This will be a 6-week, open label, bilaterally-controlled single center study involving 30 subjects age 13 and older with eczema. The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) used to treat eczema with hydrogel patch improves its efficacy. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone. All subjects will have 3 target lesions of similar severity followed throughout the study. Patients will apply hydrogel patch alone to the first lesion, TAC 0.1% cream to the second lesion, and TAC 0.1% cream occluded by hydrogel patch to the third lesion. All treatments are twice a day for a maximum of 4 weeks or until lesions are cleared. The modified Eczema Area and Severity Index (EASI) score will be used to evaluate each lesion.
|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|