Efficacy of Sarecycline in the Treatment of Moderate-to-Severe Facial Acne Vulgaris (Av): Combined Results from Three Phase 3 Studies

Authors

• James Del Rosso
• Linda Stein Gold, Henry Ford HealthFollow
• Jianzhong Zhang
• He Li
• Valerie Callender
• Glenn Dale
• Lawrence Green
• Jonathan Weiss
• Ayoub Bentohami
• Judit C. Robles
• Paul Tomondy
• Jerry Tan

Recommended Citation

Del Rosso J, Stein Gold L, Zhang J, Li H, Callender V, Dale G, Green L, Weiss J, Bentohami A, Robles JC, Tomondy P, Tan J. Efficacy of Sarecycline in the Treatment of Moderate-to-Severe Facial Acne Vulgaris (Av): Combined Results from Three Phase 3 Studies. J Am Acad Dermatol 2026; 95(1):AB193.

Document Type

Conference Proceeding

Publication Date

7-1-2026

Publication Title

J Am Acad Dermatol

Keywords

Dermatology

Abstract

Sarecycline, a narrow-spectrum oral antibiotic approved for treatment of inflammatory lesions in moderate-to-severe acne vulgaris (AV), has been evaluated in three phase 3 trials that have been reported separately. This pooled analysis of results from these trials provided information from a cohort of patients with moderate-to-severe facial AV (Investigators’ Global Assessment [IGA] 3 or 4) treated with this agent. Each trial had a 12-week duration and followed a randomized (1:1 sarecycline vs placebo in two studies and 2:1 in one study) double-blind design in which patients received sarecycline (1.5 mg/day) or placebo. Endpoints assessed included IGA success (score of 0 [clear] or almost clear [1] and a reduction from baseline >/=2), percent reduction in inflammatory lesions, and absolute reduction in the number of non-inflammatory lesions. The trials enrolled 2,393 patients (9-45 years old, 57.4% female; 64.9% white, 12.6% black, 19.0% Asian, 2.2% multiracial, and 1.3% other). At Week 12, IGA success was achieved by 25.9% of patients treated with sarecycline vs 13.3% for placebo (P<0.0001). Percent reductions in inflammatory lesions were –58.5% vs –41.2% (P<0.0001), respectively; and those for non-inflammatory lesions were –40.4% vs –29.2% (P<0.01). Pooled results from the three studies indicated a rapid onset of action for sarecycline. At 3 weeks after treatment initiation (first post-baseline evaluation), percent reductions in inflammatory lesions were –30.5% for sarecycline and –22.4% for placebo (P=0.0001). This pooled analysis demonstrates that sarecycline improves IGA and inflammatory lesions in moderate-to-severe AV, with improvements evident as early as week 3 and sustained over time.

Volume

95

Issue

1

First Page

AB193