PMID- 29537451 OWN - NLM STAT- MEDLINE DCOM- 20180905 LR - 20180905 IS - 1545-9616 (Print) IS - 1545-9616 (Linking) VI - 17 IP - 3 DP - 2018 Mar 1 TI - 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. PG - 333-338 AB - BACKGROUND: There is a need for new oral antibiotics for acne with improved safety profiles and targeted antibacterial spectra. Sarecycline is a novel, tetracycline-class antibiotic specifically designed for acne, offering a narrow spectrum of activity compared with currently available tetracyclines, including less activity against enteric Gram-negative bacteria. This phase 2 study evaluated the efficacy and safety of three doses of sarecycline for moderate to severe facial acne vulgaris. METHODS: In this multicenter, double-blind, placebo-controlled study, patients aged 12 to 45 years were randomized to once-daily sarecycline 0.75 mg/kg, 1.5 mg/kg, 3.0 mg/kg, or placebo. Efficacy analyses included change from baseline in inflammatory and noninflammatory lesion counts at week 12, with between-group comparisons using analysis of covariance. Safety assessments included adverse events (AEs), clinical laboratories, vital signs, electrocardiograms, and physical examinations. RESULTS: Overall, 285 randomized patients received at least one dose of study drug. At week 12, sarecycline 1.5 mg/kg and 3.0 mg/kg groups demonstrated significantly reduced inflammatory lesions from baseline (52.7% and 51.8%, respectively) versus placebo (38.3%; P=0.02 and P=0.03, respectively). Sarecycline was safe and well tolerated, with similar gastrointestinal AE rates in sarecycline and placebo groups. Vertigo and photosensitivity AEs occurred in less than 1% of patients when pooling sarecycline groups; no vulvovaginal candidiasis AEs occurred. Discontinuation rates due to AEs were low. No serious AEs occurred. CONCLUSION: Once-daily sarecycline 1.5 mg/kg significantly reduced inflammatory lesions versus placebo and was safe and well tolerated with low rates of AEs, including gastrointestinal AEs. Sarecycline 3.0 mg/kg did not result in additional efficacy versus 1.5 mg/kg. Sarecycline may represent a novel, once-daily treatment for patients with moderate to severe acne. It offers a narrow antibacterial spectrum relative to other tetracycline options, which may lead to less selective pressure on enteric Gram-negative bacteria, resulting in less disruption of commensal organisms and less potential for antibiotic resistance.

J Drugs Dermatol. 2018;17(3):333-338.

. FAU - Leyden, James J AU - Leyden JJ FAU - Sniukiene, Vilma AU - Sniukiene V FAU - Berk, David R AU - Berk DR FAU - Kaoukhov, Alexandre AU - Kaoukhov A LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - J Drugs Dermatol JT - Journal of drugs in dermatology : JDD JID - 101160020 RN - 0 (Anti-Bacterial Agents) RN - F8VB5M810T (Tetracycline) SB - IM MH - Acne Vulgaris/*diagnosis/*drug therapy MH - Administration, Oral MH - Adolescent MH - Adult MH - Anti-Bacterial Agents/*administration & dosage/chemistry MH - Double-Blind Method MH - Drug Administration Schedule MH - Face/*pathology MH - Female MH - Follow-Up Studies MH - Humans MH - Male MH - Tetracycline/*administration & dosage/chemistry MH - Treatment Outcome MH - Young Adult EDAT- 2018/03/15 06:00 MHDA- 2018/09/06 06:00 CRDT- 2018/03/15 06:00 PHST- 2018/03/15 06:00 [entrez] PHST- 2018/03/15 06:00 [pubmed] PHST- 2018/09/06 06:00 [medline] AID - S1545961618P0333X [pii] PST - ppublish SO - J Drugs Dermatol. 2018 Mar 1;17(3):333-338.