Efficacy of sulfasalazine in the treatment of generalized lichen planus: randomized double-blinded clinical trial on 52 patients.

BACKGROUND: Oral sulfasalazine has been reported to be effective in patients with idiopathic cutaneous lichen planus (LP).

OBJECTIVES: Our purpose was to evaluate the efficacy of this drug in the treatment of generalized cutaneous lichen planus (GLP). In this study, we evaluated the effectiveness of the anti-inflammatory drug sulfasalazine for the treatment of GLP.

METHODS: A total of 52 patients with GLP presenting at the outpatient clinic were enrolled in this double-blind, randomized, placebo-controlled, prospective study. Of these patients, 44 completed the period of study. The patients were randomly divided into two groups. One group received placebo and the other was given sulfasalazine maximum 2.5 g/day. The patients were evaluated at the third and sixth weeks of treatment for improvement rate and occurrence of complications.

RESULTS: After 6 weeks of treatment, the rate of cutaneous lesions improvement was 9.6% (two patients) in the placebo group and 82.6% (19 patients) in the sulfasalazine group. The improvement rate of pruritus was 14.3% in the placebo group and 91.3% in the sulfasalazine group. Side-effects which were mild and tolerable were detected in 30.7% of patients, but three patients left the study because of side effects. Most of the reported side-effects included gastrointestinal upset and headache.

CONCLUSIONS: Statistically, sulfasalazine was more effective than placebo in reducing cutaneous lesions and improving pruritus after 6 weeks of treatment. According to our study, sulfasalazine is a relatively safe and effective treatment option and may be an alternative therapy for the treatment of generalized lichen planus.