A randomized placebo-controlled double-blind study of levamisole in the treatment of limited and slowly spreading vitiligo.

BACKGROUND

A previous uncontrolled, open trial of levamisole in patients with limited and slowly spreading vitiligo had shown that new lesions did not develop in 94% of patients after 2-4 months of treatment with the drug.

OBJECTIVES

To assess the efficacy of levamisole in the treatment of slowly spreading, limited vitiligo.

METHODS

In a randomized double-blind trial at the Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India, 60 patients with vitiligo involving < 2% of the body surface area and with slowly spreading disease (defined as one to five new lesions in the previous month or six to 15 new lesions in the previous 3 months) were randomly allocated to receive oral levamisole 150 mg or placebo on two consecutive days in a week. Children received oral levamisole 100 mg. All patients applied mometasone furoate 0.1% cream on the depigmented macules once daily. Patients were evaluated monthly for 6 months. The main outcome measure was the occurrence of new lesions, counted at each monthly visit. The secondary outcome measures comprised: (i) a dermatology-specific instrument, the Dermatology Life Quality Index or Children's Dermatology Life Quality Index questionnaires, which were completed by the patients at baseline and at every visit, and (ii) a general health questionnaire, the World Health Organization Quality of Life Brief Questionnaire, which was completed at baseline and at the end of the study.

RESULTS

Forty-three patients completed 6 months of follow-up. The mean +/- SD number of new lesions that developed during the study period of 6 months was 1.9 +/- 2.0 (range 0-8) in the levamisole group and 1.8 +/- 2.0 (range 0-7) in the placebo group (P = 0.92). The proportion of patients who did not develop any further new lesions for the remainder of the study period was higher in the levamisole group at all the monthly evaluation points, although it was statistically significant (P = 0.05) only at the fourth month. Improvement in quality of life was similar in both groups.

CONCLUSIONS

The study indicates that levamisole is not as effective in arresting disease progression as was observed in a previous open study. A study with a larger sample size is necessary to determine if levamisole is truly superior to placebo in this respect.