A Randomized, Controlled Trial of Trifarotene Plus Doxycycline for Severe Acne Vulgaris.

Objective: We evaluated the efficacy and safety of trifarotene plus oral doxycycline in acne. Methods: This was a randomized (2:1 ratio) 12-week, double-blind study of once-daily trifarotene cream 50µg/g plus enteric-coated doxycycline 120mg (T+D) versus trifarotene vehicle and doxycycline placebo (V+P). Patients were aged 12 years or older with severe facial acne (≥20 inflammatory lesions, 30 to 120 non-inflammatory lesions, and ≤4 nodules). Efficacy outcomes included change from baseline in lesion counts and success (score of 0/1 with ≥2 grade improvement) on investigator global assessment (IGA). Safety was assessed by adverse events and local tolerability. Results: =0.0107). The safety and tolerability profiles were comparable between the T+D and V+P arms. Conclusion: T+D was demonstrated to be safe and efficacious as a treatment option for patients with severe acne.