A multi-center randomized, double-blind, right/left controlled study to evaluate the efficacy and safety of tacrolimus ointment 0.1% in the treatment of patients with chronic allergic contact dermatitis
D. Belsito1, D. Wilson2, E. Warshaw3, J. Fowler4, F. Storrs5, A. Erlich6, B. Anderson7, B. Strober8, J Hartle9, E. Rutledge*10
1University of Kansas, Kansas City, MO, United States
2Education and Research Foundation, Lynchburg, VA, United States
3University of Minnesota, Minneapolis, MN, United States
4University of Louisville, Louisville, KY, United States
5Oregon Health Science University, Portland, OR, United States
6George Washington University, Washington, DC, United States
7Pennsylvania State University, Hershey, PA, United States
8New York University, New York, NY, United States
9Fujisawa Healthcare, Inc., Deerfield, IL, United States
10Astellas Pharma US, Inc., Atlanta, GA United states
Background
Allergic contact dermatitis (ACD) is one of the most common occupationally related illnesses in the United States. ACD accounts for approximately 7% of the total annual cost of occupational disability incurred as a result of lost productivity, medical care, and disability payments. Currently, topical steroids are the mainstay of treatment for ACD, but the risks of cutaneous atrophy, adrenal suppression, and the development of steroid dermatitis limit their use for chronic treatment. A topical product that could quickly clear the severe erythema and pruritus of ACD, while still offering safety and tolerability, would play a major role in the dermatologist's and occupational medicine specialist’s armamentarium. The purpose of this study is to assess the safety and efficacy of 0.1% tacrolimus ointment in a model of chronic allergic contact dermatitis.
Methods
This is a multi-center, randomized, double-blind, vehicle-controlled, right/left comparative study. The protocol is approved by the human subjects review board. Eight centers have enrolled approximately 100 subjects with a history of allergy to nickel. Subjects were randomized to receive 0.1% tacrolimus to either the right or left arm and its vehicle to the contralateral arm. Subjects applied a nickel patch 4 – 8 hours daily and the study drug to the treatment area twice daily for eight weeks. Subjects were evaluated at weekly intervals for 3 weeks, then bi-weekly for the remainder of the 8-week period.
Results
The primary outcome of this study is to evaluate the efficacy of the treatment using the Investigator’s Global Assessment. Secondary outcomes include evaluating the efficacy using the ACD signs and symptoms and safety based on subject-reported and investigator-observed adverse events and premature study discontinuations due to study drug-related adverse events.
Conclusions
The results of this study will provide data to further test the role of topical tacrolimus in the treatment of chronic allergic contact dermatitis occurring in patients where exposure to allergens can not be avoided, such as occupational settings.
Content last modified: 21 May 2005
