BACKGROUND:Azithromycin is an azalide analogous to erythromycin; it has an anti-inflammatory action that prevents the growth of Propionibacterium acnes, a major microorganism involved in the pathogenesis of inflammatory acne. METHODS: An open, multicentric, non-comparative study was performed with 57 patients to evaluate the efficacy, tolerability and safety of azithromycin in the treatment of grade 2 inflammatory vulgar acne, using a regimen of three monthly pulses of 500 mg for 3 consecutive days. The efficacy was evaluated using the Physician's Global Evaluation of Clinical Response Scale. The drug's safety was monitored by standard laboratory analyses and by the incidence of adverse events. RESULTS:Azithromycin showed a significant statistical reduction of the number of lesions in the different regions of the face between the basal and final visits (p<0.001). The laboratory changes associated with the treatment with azithromycin were not clinically significant. The majority of adverse events reported were related to the gastrointestinal and central nervous systems, and were classified as mild or moderate. Only two patients had to be withdrawn from the study due to adverse events. CONCLUSION: Three monthly pulses of azithromycin 500 mg for 3 consecutive days is safe, well tolerated, effective and promotes increased patient adhesion to the treatment.
RCT Entities:
BACKGROUND:Azithromycin is an azalide analogous to erythromycin; it has an anti-inflammatory action that prevents the growth of Propionibacterium acnes, a major microorganism involved in the pathogenesis of inflammatory acne. METHODS: An open, multicentric, non-comparative study was performed with 57 patients to evaluate the efficacy, tolerability and safety of azithromycin in the treatment of grade 2 inflammatory vulgar acne, using a regimen of three monthly pulses of 500 mg for 3 consecutive days. The efficacy was evaluated using the Physician's Global Evaluation of Clinical Response Scale. The drug's safety was monitored by standard laboratory analyses and by the incidence of adverse events. RESULTS:Azithromycin showed a significant statistical reduction of the number of lesions in the different regions of the face between the basal and final visits (p<0.001). The laboratory changes associated with the treatment with azithromycin were not clinically significant. The majority of adverse events reported were related to the gastrointestinal and central nervous systems, and were classified as mild or moderate. Only two patients had to be withdrawn from the study due to adverse events. CONCLUSION: Three monthly pulses of azithromycin 500 mg for 3 consecutive days is safe, well tolerated, effective and promotes increased patient adhesion to the treatment.