Efficacy of 10% azelaic acid gel with hydro-alcoholic or alcohol-free bases in mild to moderate acne vulgaris; the first clinical trial

Abstract

Azelaic Acid is a very effective topical medication for treating acne vulgaris. This study aims to compare the efficacy of 10% azelaic acid gel with hydro-alcoholic and alcohol-free bases in mild-to-moderate acne vulgaris. This randomized, double blind, clinical trial, 40 patients with mild-to-moderate acne vulgaris were recruited from Sina Hospital from November 2009 through March 2011. They randomized in two equal age and sex-matched groups, receiving 10% azelaic acid gel with either hydro-alcoholic base or alcohol-free base once at night on their face for eight consecutive weeks. All the patients were revisited on weeks 1, 2, 4, 6 and 8 after treatment and facial acne lesions were counted on each session. Possible complications, as well as the effect of skin type were investigated. Total, inflammatory and noninflammatory acne lesion counts decreased significantly in both groups by the end of study period. However, there was no significant difference between the two groups in this regard (p<0.05). There were minor, self-limited complications, including 3 cases of mild itching in both groups. For the count of inflammatory lesions, azelaic gel with alcoholic base was significantly more effective than azelaic gel with alcohol-free base in patients with oily facial skin (p = 0.02). All the patients (100%) were very satisfied with their treatments. In conclusion, both 10% azelaic gels with hydro-alcoholic and alcohol-free bases were comparably effective against mild-to-moderate acne vulgaris. In patients with oily skin, however, 10% azelaic acid with hydro-alcoholic base was superior to the medication with alcohol-free base in patients with oily skin.