Clinical Evaluation of Roxithromycin: A Double‐Blind, Placebo‐Controlled and Crossover Trial in Patients with Acne Vulgaris

Abstract

We clinically evaluated roxithromycin (ROM) in a double blind, placebo-controlled, and crossover trial in patients with inflammatory acne. Patients with inflammatory acne who were attending our outpatient clinic for treatment and who had not received topical or systemic treatment for the previous month were enrolled in this study. Patients were randomly separated into two groups. Group I consisted of 26 patients. The patients received 2x150 mg/day ROM orally in the first period and 2x1 placebo tablets/day in the second period. Group II consisted of 20 patients. These patients received 2x1 placebo tablets/day in the first period and 2x150 mg/day ROM orally in the second period. The first period was the first four weeks, and then there was a washout period of two weeks (5th and 6th). The second period was the next four weeks (7th to 10th weeks) after the washout period. Median acne scores had clearly decreased in both groups at the end of the study. Differences of median acne scores were statistically significant in both groups between at baseline and at the end of the study (p<0.001). The results showed that ROM is a safe and effective alternative in the treatment of inflammatory acne with few side effects and good compliance.

Systemic antibiotic therapy of acne vulgaris

“…Differences compared to tetracyclines have not been shown. In the past years trials have been published as to the efficacy of newer macrolides such as roxithromycin [26, 27] and azithromycin [28, 29]. No advantages in treating acne could be shown.…”

Japanese Dermatological Association Guidelines: Guidelines for the treatment of acne vulgaris 2017

“…It is approved for use for acne (inflammatory acne lesions). One RCT has shown its effectiveness in comparison with roxithromycin and placebo. Two RCT showed no significant difference in the reduction of inflammatory acne lesions when compared with minocycline and faropenem.…”

Efficacy of oral antibiotics on acne vulgaris and their effects on quality of life: A multicenter randomized controlled trial using minocycline, roxithromycin and faropenem

“…Minocycline (MINO) has been examined in the systematic review 3 based on many randomized controlled trials (RCT), and has been strongly recommended (recommendation level A) in the Guideline. Roxithromycin (RXM), the only oral macrolide indicated for acne in Japan, is recommended (recommendation level B) in the Guideline because a randomized placebo‐controlled trial 4 has been conducted. Faropenem (FRPM), an oral penem, has the indication for acne in Japan and has shown potent antibacterial activity against Propionibacterium acnes 5 ( P. acnes ) and clinical effectiveness for inflammatory acne in a case‐accumulation study 6,7 .…”