RESUMEN
BACKGROUND: Levamisole is an agent without much potential use alone, but through immunomodulation, may synergistically improve the efficacy of other drugs like doxycycline in the treatment of acne vulgaris. OBJECTIVE: The goal of this study was to determine the efficacy of levamisole in addition to doxycycline in the treatment of patients suffering from severe nodulocystic acne. METHODS: A double-blind, randomized, placebo-controlled trial was conducted in the dermatology clinic of Rasoul-e-Akram Hospital in Tehran, Iran in 2006. Sixty patients were randomly assigned to 1 of 2 study groups. The case group was administered oral levamisole 2.5 mg/kg/wk (up to 150 mg/wk) plus doxycycline 100 mg daily and the control group was given 100 mg of oral doxycycline daily and a placebo. Patients were evaluated at baseline, and at 2-month, 4-month, and 6-month checkpoints. RESULTS: The responses to treatment were significantly higher in the case group according to the reduction in total lesions count, acne severity index; and papule/pustule and nodule/cyst count at the 2nd, 3rd, and 4th visits. CONCLUSION: Results indicated that adding oral levamisole to doxycycline is an effective treatment for severe nonresponsiveness to conventional treatments of acne vulgaris. In the patient group, levamisole was well tolerated with an acceptable safety profile. At the time of publication, this study is the first clinical trial that suggests levamisole as an effective new treatment for severe acne vulgaris.