Tacrolimus ointment 0.1% in the treatment of nickel-induced allergic contact dermatitis.

Abstract

BACKGROUND:

Tacrolimus is a macrolactam that prevents the transcription of messenger RNA for various inflammatory cytokines in both helper T cells (types 1 and 2) (T(H)1 and T(H)2). It is currently approved for the treatment of moderate to severe atopic dermatitis, a Th2-mediated disease, in children and adults.

OBJECTIVE:

We sought to evaluate the safety and efficacy of tacrolimus ointment 0.1% in the treatment of nickel-induced allergic contact dermatitis, a T(H)1-mediated disease.

METHODS:

This was a double-blind, randomized, vehicle-controlled, bilateral paired comparison study to assess the safety and efficacy of topical tacrolimus (Protopic, Fujisawa Healthcare Inc, Deerfield, Ill) ointment 0.1% in the treatment of allergic contact dermatitis induced by nickel sulfate. Volunteers were individuals with known hypersensitivity to nickel. Reactivity to nickel was graded both as the investigator's global assessment and total signs and symptoms, which consisted of the cumulative grade from 0 to 4 for each of the following parameters: erythema, induration, vesiculation, and pruritus (range of scores: 0-16). Reactivity was assessed in the per-protocol group at 1 and 2 weeks after beginning treatment with study drug and control. Adverse events were assessed in the intent-to-treat population.

RESULTS:

Of the 19 volunteers who completed the study (per protocol), 18 had an improvement in total signs and symptoms with tacrolimus versus 10 patients with the vehicle. Of patients, 80% had an improvement in the investigator's global assessment score on the tacrolimus-treated site versus 30% of patients on the placebo-treated site. Overall, tacrolimus was more effective than placebo in ameliorating the nickel reaction. Although the tacrolimus treated site was clear or almost clear in a greater number of individuals at week 1, this difference did not become significant until the second week of the study. Other than application site burning in 25% of volunteers, no significant adverse events were noted in the intent-to-treat population.

CONCLUSION:

Topical tacrolimus (Protopic, Fujisawa Healthcare Inc) ointment 0.1% may be an option for the treatment of allergic contact dermatitis induced by nickel.

• Authors: Yamini V Saripalli, Joseph E Gadzia, Donald V Belsito
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 49 Issue 3 Pg. 477-82 (Sep 2003) ISSN: 0190-9622 [Print] United States
• PMID: 12963912 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Immunosuppressive Agents
• Ointments
• Nickel
• Tacrolimus

Topics

• Administration, Topical
• Adult
• Cross-Over Studies
• Dermatitis, Allergic Contact (drug therapy, etiology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Immunosuppressive Agents (administration & dosage)
• Male
• Middle Aged
• Nickel (adverse effects)
• Ointments
• Patch Tests
• Reference Values
• Risk Assessment
• Severity of Illness Index
• Tacrolimus (administration & dosage)
• Treatment Outcome