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ABSTRACT: 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.

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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.
INTRODUCTION
Acne is one of the most common dermatological diseases encountered in the medical practice, affecting almost 80% to 85% of young adults. Recent research has improved our understanding of the complex immunepathophysiology of the disease; however, knowledge about the sequence of events leading to the onset of acne is still incomplete and a subject of controversy. (1-4) Nodulocystic acne may consist of comedones and inflammatory lesions, as well as deeper nodules and cysts. Nodulocystic acne requires frequent treatment with long-term systemic antibiotics or isotretinoin. Topical agents may be insufficient to treat inflammatory acne. (5) Oral isotretinoin is currently the most effective acne treatment available. However, it has a wide range of side effects including teratogenicity as the most notable one and mucocutaneous, ophthalmic, and musculoskeletal effects and effects on plasma lipids and liver function tests. Furthermore, long-term remission rates as high as 70% to 89% after discontinuation of isotretinoin and its side effects limits its usage. (6-14) Moreover, development of antibiotic resistance in Propionibacterium acnes necessitates the search for new alternative treatments for acne.
Various immune factors, including both innate and adaptive immune responses, have been implicated in the pathophysiology of inflammatory acne. (15), (16) Levamisole is an antihelminthic drug which also has immunomodulator properties. The latter action has been used in the treatment of the variety of systemic and dermatological disorders. (17-22) A double-blind, randomized, controlled trial was designed to evaluate the efficacy of levamisole in addition to doxycycline in the treatment of patients suffering from severe nodulocystic acne. The possible side effects of this drug are also discussed.
METHODS
This study is a double-blind, randomized, placebo-controlled trial conducted in Rasoul-e-Akram Hospital in Tehran, Iran. Using the convenience method, 60 patients of the dermatology clinic suffering from severe nodulocystic acne were enrolled in the study. Inclusion criteria were severe nodulocystic acne diagnosed by a dermatologist, with no history of levamisole or doxycycline treatment during the last month, and no history of allergy to these medications. No other topical acne treatments or systemic antibiotics were permitted during the month proceeding the trial period and during the course of the trial. Patients who were treated with isotretinoin must have discontinued treatment 6 months prior to the start of the study. Subjects were not permitted to use a hormonal method of contraception 6 months before starting or during the course of the study. Patients who had a background of drug sensitivity or had hepatic or kidney disease, malnutrition, pregnancy, or lactation were excluded from the study.
The proposal of the study and all stages of this trial were approved by the Ethic Committee of Iran University of Medical Sciences. Written informed consent was required from all subjects.
The 60 subjects were divided into the case and control groups randomly. The 30-patient case group was given oral levamisole 2.5 mg/kg/wk (up to 150 mg/wk) plus doxycycline 100 mg and the control group was given 100 mg oral doxycycline and a matching placebo. Subjects were evaluated for 6 months in intervals of 2 months. Every 2 weeks, complete blood count (CBC), plasma blood urea nitrogen (BUN), and creatinine levels were checked. Patients were directed to call the physician if any of the explained side effects were experienced. In the case of any severe side effects (ie, leucopenia or rashes) or the need to change the treatment or any condition disrupt the inclusion criteria, patients were discontinued from the study. Total lesion count (TLC), total number of papules, nodules, pustules, cysts, and severity of acne (graded according to the method of Burke and Cunliffe (23)) was considered to be 100% at the first visit for each patient. Any subsequent decrease in the number was calculated accordingly and regarded as the percent improvement. The difference between mean percents of improvement in the 2 groups were compared using t test, and the level of significance was considered 0.05. The authors used SPSS[R] (V13.0 SPSS Inc, Chicago, IL) software for statistical analysis.