1. Background
Acne vulgaris is the sebaceous glands multifactorial disease and Propionibacterium acnes is one of the etiologic factors of acne vulgaris (1-3). Malassezia furfur provides an appropriate environment for the growth of P. acnes. Miconazole is an antifungal drug that inhibits P. acnes growth by eradicating M. furfur. Therefore, it can be used in patients with mild to moderate acne as an adjuvant therapy. The efficacy of miconazole plus benzoyl peroxide in treatment of the acne vulgaris has been reported in the previous studies (4-9). Benzoyl peroxide is expensive and also a strong irritant in darker skin types. Dark skin types of our population make it more prone to be more susceptible to cutaneous irritation while treating with this formulation.
2. Objectives
Therefore, we evaluated the efficacy of erythromycin plus miconazole alcoholic solution in treatment of mild to moderate acne lesions. This formulation is cheap and available and its efficacy had not been studied previously.
3. Patients and Methods
In a single-blinded randomized clinical trial, 60 patients who were referred to dermatologic clinics of Isfahan University of Medical Sciences with mild and moderate acne were recruited by simple random sampling method. Pregnant or lactating mothers with any internal or endocrine disease, and those who used any medication for the treatment of acne in the preceding month were excluded. Informed consents were obtained from the participants. Patients were randomly allocated to two groups to receive treatment with 2% erythromycin alcoholic solution and 2% erythromycin plus 2% miconazole alcoholic solution. Patients were instructed to apply the solution on the acnes every night and to wash it next morning. The patients were assessed at the beginning and at the first, second, and the third month in follow-up visits. Reduction of acne lesions and relevant side effects were recorded in a questionnaire during monthly clinical visits. The efficacy of treatment was evaluated by absolute lesion count for each type of acne lesion and Acne Severity Index (ASI). ASI was calculated as follows:
ASI = (pustules × 2) + papules + (1.4 × comedones)
At the first visit, the total number of lesions was assumed to be 100% and any reduction in severity of lesions was calculated as above mentioned and was considered as percent improvement. The mean improvement percentage was calculated in both treatment groups. The effectiveness of treatment was graded as follow: the improvement < 20%, low; 20% to 60%, moderate; and > 60%, excellent. Student t-test was used to analyze the data using the SPSS (version 13, SPSS Inc., Chicago, IL, USA).
4. Results
Out of 60 patients, 56 patients (94%) were female and four patients (6%) were male. The mean age of patients was 17.63 years. Although at the first month of treatment, the improvement percentage was higher in the group treated with erythromycin solution than in the group treated with erythromycin plus miconazole solution (P < 0.05), erythromycin plus miconazole alcoholic solution showed an increased improvement in the second and the third months of treatment comparing to the other group (P < 0.05) (Table 1). Both treatment methods were highly effective in resolving inflammatory acne lesions (papules and pustules) and were least effective in reducing noninflammatory lesions (comedones). Although the efficacy of erythromycin plus miconazole solution in reducing ASI was graded as mild during the first month of treatment, it was graded as excellent in the second and the third months of therapy. The patients were relatively highly satisfied with both of the therapeutic methods. Erythema was the most common side effect in erythromycin plus miconazole group. It was more intensive early in the course of treatment and gradually relieved. The most common side effect in erythromycin plus miconazole solution group was moderate itching that decreased during the treatment and there was no need to stop .
Table 1. Mean Improvements of Acne Lesions in Two study Groups a
| Treatment Group | Acne Lesions at the Baseline Visit | Improvement at Follow-p | ||
|---|---|---|---|---|
| The First Visit | The Second Visit | The Third Visit | ||
| Erythromycin Plus Miconazole | 100 | 27.9 | 53.7 | 81.5 |
| Erythromycin | 100 | 29.12 | 42.6 | 70.95 |
| P Value | 0 | 0.002 | 0.001 | 0.001 |
aData are presented as %.
5. Discussion
Propionibacterium acnes is one of the most important causative agents of acne vulgaris. Malassezia furfur is one of the leading acne factors by providing an appropriate environment for growth of this bacterium. Some studies have recently shown the role of M. furfur in inducing acne lesions and miconazole as an effective topical drug in acne treatment. To the best of our knowledge, up to this date, no previous study on the efficacy of miconazole and the formulations used for treatment of various types of acne lesions has been published. In 1980, one study demonstrated that combination of miconazole and retinoic acid could mitigate superficial acne lesions (10). Several studies have reported the efficacy of miconazole plus benzoyl peroxide in acne treatment (4-9). More recently, Petit et al. showed that overnight application of a paste containing 15% zinc oxide and 0.025% miconazole nitrate reduces the inflammatory acne lesions. They recommended a single overnight premenstrual application of a paste containing miconazole nitrate to prevent premenstrual acne flare-ups (11). In addition to efficacy, the price and side effects are the other important factors that should be considered while choosing a drug (12). Erythromycin plus miconazole alcoholic solution is a cheap, available, and well-tolerated drug that has not been studied previously.
The results showed that erythromycin plus miconazole alcoholic solution were more effective than erythromycin solution in acne treatment, especially in treating inflammatory acne lesions. The efficacy of erythromycin plus miconazole alcoholic solution ASI reduction changed from mild in the first month of treatment to excellent in the third month of treatment. In conclusion, this study showed that erythromycin plus miconazole alcoholic solution is an effective therapeutic method for treatment of mild to moderate acne lesions.
