Bhatia Neal D, Werschler Wm Philip, Baldwin Hilary, Sugarman Jeffrey, Green Lawrence J, Levy-Hacham Ofra, Nov Ori, Ram Vered, Stein Gold Linda
Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California.
Dr. Werschler is with the University of Washington and Premier Clinical Research in Spokane, Washington.
J Clin Aesthet Dermatol. 2023 Aug;16(8):34-40.
A new formulation of benzoyl peroxide (E-BPO cream, 5%) entraps benzoyl peroxide (BPO) in silica microcapsules. This study assesses the efficacy, safety, and tolerability of E-BPO cream, 5%, in rosacea in two Phase III clinical trials.
In two 12-week, randomized, double-blind, vehicle cream-controlled Phase III trials, 733 subjects at least 18 years old with moderate to severe rosacea were randomized (2:1) to once-daily E-BPO cream, 5%, or vehicle.
In Study 1, the proportion of subjects achieving IGA clear/almost clear at Week 12 was 43.5 percent for E-BPO cream, 5%, and 16.1 percent for vehicle. In Study 2, the respective values were 50.1 percent and 25.9 percent. In Study 1, the decrease in lesion count from baseline to Week 12 was -17.4 for E-BPO cream, 5%, versus -9.5 for vehicle. In Study 2, the respective values were -20.3 and -13.3 (all <0.001). The difference was also significant at Week 2. There were no treatment-related serious adverse events; 1.4 percent of subjects (1.8% E-BPO cream, 5%, 0.4% vehicle) discontinued due to adverse events. Assessed local tolerability was found to be similar among subjects in both E-BPO and vehicle.
E-BPO was not compared with unencapsulated BPO.
E-BPO is an effective and well tolerated treatment for rosacea. Clinicaltrials.gov Identifiers: NCT03564119, NCT03448939.
一种新的过氧化苯甲酰制剂（E - BPO乳膏，5%）将过氧化苯甲酰（BPO）包裹于二氧化硅微囊中。本研究在两项III期临床试验中评估5% E - BPO乳膏治疗酒渣鼻的疗效、安全性和耐受性。
在两项为期12周、随机、双盲、赋形剂乳膏对照的III期试验中，733名年龄至少18岁的中度至重度酒渣鼻患者被随机分组（2:1），分别每日一次使用5% E - BPO乳膏或赋形剂。
在研究1中，第12周时达到IGA清除/几乎清除的受试者比例，5% E - BPO乳膏组为43.5%，赋形剂组为16.1%。在研究2中，相应数值分别为50.1%和25.9%。在研究1中，从基线到第12周皮损计数的减少，5% E - BPO乳膏组为 - 17.4，赋形剂组为 - 9.5。在研究2中，相应数值分别为 - 20.3和 - 13.3（均P<0.001）。在第2周时差异也显著。未发生与治疗相关的严重不良事件；1.4%的受试者（5% E - BPO乳膏组为1.8%，赋形剂组为0.4%）因不良事件停药。评估发现E - BPO组和赋形剂组受试者的局部耐受性相似。
未将E - BPO与未包裹的BPO进行比较。
E - BPO是一种治疗酒渣鼻有效且耐受性良好的药物。Clinicaltrials.gov标识符：NCT03564119，NCT03448939。
