Sarecycline Monotherapy Delivers in Real-World Acne Study

A post hoc analysis of the PROSES study found that oral sarecycline monotherapy is as effective as combination therapy with topicals in treating moderate-to-severe acne vulgaris (AV), based on 12-week outcomes from a real-world U.S. cohort presented by Dr. Hilary Baldwin et al at the 2025 Fall Clinical Dermatology Conference.

The Patient Reported Outcomes for Sarecycline Effectiveness and Safety (PROSES) was a single-arm, prospective cohort study conducted across 30 dermatology practices. The study enrolled 300 patients aged ≥9 years with facial non-nodular moderate-to-severe AV who were prescribed oral sarecycline (60 mg, 100 mg, or 150 mg) as part of routine care.

Among the 245 evaluable patients, 121 received sarecycline alone, while 124 used it in combination with at least one topical treatment. At 12 weeks, 61.2% of patients on monotherapy and 57.2% on combination therapy achieved an Investigator’s Global Assessment (IGA) of “clear” or “almost clear” (P = .6033).

Subgroup results showed variable outcomes depending on the topical agent used:

• Sarecycline + tretinoin: 75.0%

• Sarecycline + any retinoid: 73.2%

• Sarecycline + adapalene/benzoyl peroxide: 57.1%

• Sarecycline + benzoyl peroxide: 54.5%

• Sarecycline + trifarotene: 53.8%

• Sarecycline + tazarotene: 47.1%

No formal comparisons between subgroups were performed, and small sample sizes limit interpretability. Adherence was monitored for sarecycline but not for adjunct therapies.

“The efficacy of sarecycline in patients with moderate-to-severe AV is comparable in those who were or were not receiving concomitant non-oral antibiotic therapy,” the authors concluded. “Results for individual agents combined with sarecycline should be viewed with caution due to small sample sizes”.