Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: results of a randomized, double-blind, vehicle-controlled study.

Abstract

BACKGROUND:

Vitiligo is an acquired, pigmentary skin disorder which is disfiguring and difficult to treat. In an earlier open label study in adult patients with vitiligo, pimecrolimus cream 1% was reported to have similar efficacy as clobetasol propionate 0.05%. We performed a double-blind, intrapatient comparison of pimecrolimus cream 1% with placebo cream.

PATIENTS AND METHODS:

Twenty adult Caucasians with symmetrical vitiligo (predominantly on extremities, none in the face) were treated b.i.d. for 6 months left/right with pimecrolimus/vehicle (N = 10) or vehicle/pimecrolimus (N = 10), respectively. Primary efficacy endpoint was the size of the target lesion at month 6 and secondary efficacy endpoint was re-pigmentation.

RESULTS:

Treatment with pimecrolimus cream 1% or vehicle resulted in no significant change in mean target lesion size. Modest repigmentation (1-25%) was noted with pimecrolimus at month 2 in 12 of 17 patients (vehicle: 9 of 17 patients). Afterwards, the number of patients who experienced an improvement of pigmentation steadily decreased (3 of 14 patients with pimecrolimus and 2 of 14 with placebo at month 6). Treatment was well tolerated. There were no treatment-related adverse events, no induction of skin atrophy nor any other application site side effects.

CONCLUSION:

In this group of adult patients with symmetrical vitiligo, treatment of body lesions (except face) with pimecrolimus cream 1% could not be shown to be effective.

• Authors: Markus Dawid, Marge Veensalu, Maximilian Grassberger, Klaus Wolff
• Journal: Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG (J Dtsch Dermatol Ges) Vol. 4 Issue 11 Pg. 942-6 (Nov 2006) ISSN: 1610-0387 [Electronic] Germany
• PMID: 17081269 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dermatologic Agents
• pimecrolimus
• Tacrolimus

Topics

• Administration, Topical
• Adolescent
• Adult
• Child
• Dermatologic Agents (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Placebo Effect
• Risk Assessment (methods)
• Risk Factors
• Tacrolimus (administration & dosage, adverse effects, analogs & derivatives)
• Treatment Outcome
• Vitiligo (diagnosis, drug therapy)