Clinical Trial: Hydrogel Patch for the Treatment of Eczema
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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
Brief Summary: The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) with hydrogel patch improves its efficacy in treating eczema. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone, without TAC.
Detailed Summary: 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.
Sponsor: University of California, San Francisco
Current Primary Outcome: Change in Disease Severity: Percent Change in Mean EASI Score [ Time Frame: Baseline, 6 weeks ]
Original Primary Outcome: Percentage of Patients with significant improvement of eczema [ Time Frame: 6 weeks ]
Current Secondary Outcome: Number of Adverse Events Associated With Treatment [ Time Frame: 6 weeks ]
Original Secondary Outcome: Percentage of Adverse Events Associated with treatment [ Time Frame: 6 weeks ]
Information By: University of California, San Francisco
Dates:
Date Received: June 17, 2009
Date Started: July 2008
Date Completion:
Last Updated: December 30, 2013
Last Verified: December 2013