Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis (Tachyphylaxis)
This study has been completed.
Patel, Rita Vikram, M.D.
First Posted: July 28, 2011
Last Update Posted: July 28, 2011
Information provided by:
Patel, Rita Vikram, M.D.
Tachyphylaxis occurs when a medication is applied multiple times and a decreased response takes place. Many dermatologists believe that tachyphylaxis to topical steroids commonly occur. Other believe that tachyphylaxis can be explain by patient non-compliance with topical medications. This study is looking to prove or disprove the phenomenon of tachyphylaxis by using topical steroids in the psoriasis patient population. The investigators are looking to enroll 10 patients with symmetric, bilateral, and small psoriasis plaques. The investigators will either apply a strong topical steroid or a vehicle ointment to the plaques, which is be occluded with a band aid for a one week period. Weekly, the investigators will inspect the plaques for tachyphylaxis. This regimen will be repeated during phase 2, to see if there is change in the time to tachyphylaxis. This regimen will be repeated during phase 3, however, both plaques will be treated with steroid in this phase, and time to tachyphylaxis will be measured.
|Psoriasis||Drug: Halobetasol 0.05% ointment Drug: Placebo Ointment||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Basic Science
|Official Title:||An Investigator-Initiated, Double-Blind, Vehicle-Controlled Study: Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Patel, Rita Vikram, M.D.:
Primary Outcome Measures:
- Time to Tachyphylaxis [ Time Frame: 4 Weeks ]Phase 1: %change in TLSS of target lesion versus comparator lesion Phase 2a, after an interim discontinuation period of 4-8 weeks: %change in TLSS of target lesion versus comparator lesion Phase 2b, after an interim discontinuation period of 4-8 weeks: Percent change in TLSS of the comparator lesion (now switched to open-label halobetasol 0.05% ointment) versus target lesion
|Study Start Date:||June 2011|
Active Comparator: Active Arm
1. Active arm/Target Lesion: Halobetasol 0.05% ointment applied under occlusion to be left in place for one week
|Drug: Halobetasol 0.05% ointment|
Placebo Comparator: Vehicle Arm
Vehicle arm/Comparator Lesion: Vehicle ointment applied under occlusion to be left in place for one week
|Drug: Placebo Ointment|
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