Del Rosso James Q, Johnson Sandra Marchese, Schlesinger Todd, Green Lawrence, Sanchez Nestor, Lain Edward, Draelos Zoe, York Jean-Philippe, Chavda Rajeev
Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada and Advanced Dermatology and Cosmetic Surgery Clinical Research in Maitland. Florida.
Dr. Johnson is with Johnson Dermatology in Fort Smith, Arkansas.
J Clin Aesthet Dermatol. 2022 Jul;15(7):E53-E59.
We evaluated the efficacy and safety of trifarotene plus oral doxycycline in acne.
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.
The study enrolled 133 subjects in the T+D group and 69 subjects in the V+P group. The population was balanced, with an approximately even ratio of adolescent (12-17 years) and adult (≥18 years) subjects. The absolute change in lesion counts from baseline were: -69.1 T+D versus -48.1 V+P for total lesions, -29.4 T+D versus -19.5 V+P for inflammatory lesions, and -39.5 T+D versus -28.2 for non-inflammatory lesions (<0.0001 for all). Success was achieved by 31.7 percent of subjects in the T+D group versus 15.8 percent in the V+P group (=0.0107). The safety and tolerability profiles were comparable between the T+D and V+P arms.
T+D was demonstrated to be safe and efficacious as a treatment option for patients with severe acne.
我们评估了三氟罗汀联合口服多西环素治疗痤疮的疗效和安全性。
这是一项随机（2:1比例）、为期12周的双盲研究，比较每日一次的50µg/g三氟罗汀乳膏加肠溶多西环素120mg（T+D）与三氟罗汀赋形剂加多西环素安慰剂（V+P）的疗效。患者年龄在12岁及以上，患有重度面部痤疮（≥20个炎性皮损、30至120个非炎性皮损且≤4个结节）。疗效指标包括皮损计数相对于基线的变化以及研究者整体评估（IGA）的成功情况（0/1分且改善≥2级）。通过不良事件和局部耐受性评估安全性。
该研究纳入了133名T+D组受试者和69名V+P组受试者。两组人群均衡，青少年（12 - 17岁）和成人（≥18岁）受试者比例大致相同。相对于基线，皮损计数的绝对变化为：总皮损T+D组为-69.1，V+P组为-48.1；炎性皮损T+D组为-29.4，V+P组为-19.5；非炎性皮损T+D组为-39.5，V+P组为-28.2（所有比较均P<0.0001）。T+D组31.7%的受试者取得成功，V+P组为15.8%（P = 0.0107）。T+D组和V+P组的安全性和耐受性概况具有可比性。
对于重度痤疮患者，T+D被证明是一种安全有效的治疗选择。
