Tan Jerry, Stein Gold Linda, Schlessinger Joel, Brodell Robert, Jones Terry, Cruz Alma, Kerrouche Nabil, Jarratt Michael
Windsor Clinical Research Inc., Windsor, Ontario, Canada.
J Drugs Dermatol. 2012 Feb;11(2):174-80.
Few long-term treatment regimens for severe acne vulgaris have been investigated in clinical trials. Data were combined from two consecutive, randomized, double-blind, controlled studies to evaluate the efficacy, safety and subject satisfaction of four nine-month regimens in severe acne vulgaris treatment. Subjects were first randomized to receive doxycycline (DCN) and adapalene 0.1% - benzoyl peroxide 2.5% (A/BPO) or vehicle once daily for 12 weeks. Subjects who had at least 50% global improvement were subsequently randomized to receive A/BPO or its vehicle once daily for 24 weeks. Over nine months, there were four regimens: A/BPO and DCN followed by A/BPO, vehicle and DCN followed by A/BPO, A/BPO and DCN followed by vehicle, and vehicle and DCN followed by vehicle. Among the four regimens, A/BPO and DCN followed by A/BPO led to the highest percentage of subjects rated "clear" or "almost clear" (50.0% vs. 40.4%, 26.2% and 25.0%, respectively), biggest reduction in total lesion counts (76% vs. 70%, 51% and 47%, respectively) and greatest subject satisfaction (85.0% vs. 75.5%, 63.3% and 52.4%, respectively) at week 36. It provided a faster onset of action compared to groups started with vehicle and DCN (P<.05 at week 2). Subjects receiving A/BPO and DCN followed by vehicle experienced deterioration once the active treatment was discontinued. All regimens were safe and well-tolerated. In conclusion, efficacious initial therapy and long-term treatment are both important. An initial combination therapy with adapalene-BPO and DCN followed by longer-term adapalene-BPO treatment is an efficacious and satisfactory new regimen for severe acne subjects.
针对重度寻常痤疮的长期治疗方案在临床试验中鲜有研究。本研究合并了两项连续的随机双盲对照研究的数据，以评估四种为期九个月的治疗方案在重度寻常痤疮治疗中的疗效、安全性及受试者满意度。受试者首先被随机分为两组，一组每日接受一次强力霉素（DCN）和0.1%阿达帕林-2.5%过氧化苯甲酰（A/BPO），另一组接受赋形剂，为期12周。至少有50%整体改善的受试者随后被随机分为两组，一组每日接受一次A/BPO，另一组接受赋形剂，为期24周。九个月内有四种治疗方案：A/BPO和DCN后接A/BPO、赋形剂和DCN后接A/BPO、A/BPO和DCN后接赋形剂、赋形剂和DCN后接赋形剂。在这四种治疗方案中，A/BPO和DCN后接A/BPO方案在第36周时，被评为“清除”或“几乎清除”的受试者比例最高（分别为50.0%，而其他三组分别为40.4%、26.2%和25.0%），总皮损计数减少最多（分别为76%，而其他三组分别为70%、51%和47%），受试者满意度最高（分别为85.0%，而其他三组分别为75.5%、63.3%和52.4%）。与以赋形剂和DCN开始治疗的组相比，该方案起效更快（第2周时P<0.05）。接受A/BPO和DCN后接赋形剂治疗的受试者在停止活性治疗后病情恶化。所有治疗方案均安全且耐受性良好。总之，有效的初始治疗和长期治疗都很重要。阿达帕林-过氧化苯甲酰与强力霉素联合进行初始治疗，随后长期使用阿达帕林-过氧化苯甲酰治疗，是一种针对重度痤疮受试者有效且令人满意的新方案。
