Sarecycline Safe, Effective for Treatment of Acne Vulgaris
Results showed significant reduction in inflammatory lesions across 12 weeks in patients receiving sarecycline 1.5 mg/kg and 3.0 mg/kg vs placebo.
According to the results of a multicenter, double-blind, placebo-controlled phase 2 study published in the Journal of Drugs in Dermatology, once-daily 1.5 mg/kg sarecycline may represent a new treatment option for patients suffering from moderate to severe acne; it was well-tolerated by study participants and reduced inflammatory lesions.
Doxycycline and minocycline, oral tetracycline antibiotics that are currently used to treat acne, have a broad spectrum of activity on various bacteria, leading to several adverse effects.
Sarecycline is a new tetracycline-class antibiotic that is narrower in its effects and therefore better targeted against Propionibacterium acne and other gram-positive bacteria causing acne.
Investigators recruited 285 patients with moderate to severe acne per physician assessment, all between ages 12 and 45 years. Each patient was randomly assigned (1:1:1:1) to 1 of 4 treatment groups: once-daily sarecycline 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg, or placebo. Inflammatory and noninflammatory lesions were assessed from baseline to week 12, with interim visits additionally scheduled at weeks 1, 2, 4, 5, 8, and 10. Safety data were collected on adverse events.
Results showed significant reduction in inflammatory lesions across 12 weeks in patients receiving sarecycline 1.5 mg/kg and 3.0 mg/kg vs placebo (52.7% and 51.8% [P =.02], and 38.3% [P =.03], respectively). Sarecycline 3.0 mg/kg was not more efficacious than 1.5 mg/kg. Noninflammatory lesions decreased for all groups at follow-up (34.9%, 37.5%, 32.3%, and 35.2%, respectively); however, none of these changes were significant compared with placebo (P =.96, P =.68, and P =.62, respectively).
Adverse events included vertigo and photosensitivity in patients receiving sarecycline; these patients comprised <1% of the sample. Adverse event rates were comparable across all groups, including placebo, and no serious adverse events occurred.
Although this study is limited by its small sample size, the evidence suggests that oral sarecycline 1.5 mg/kg administered once daily may be a viable treatment option for moderate to severe acne. The authors recommend further testing in a phase 3 clinical trial.
Disclosures: Funding for the study was provided by Allergan plc. All authors declare affiliations with Allergan, plc.
Leyden JJ, Sniukiene V, Berk DR, et al. Efficacy and safety of sarecycline, a novel, once-daily, narrow spectrum antibiotic for the treatment of moderate to severe facial acne vulgaris: results of a phase 2, dose-ranging study. J Drugs Dermatol. 2018:17(3):333-338.