Department of Dermato-Cancerology, CIC 1413, CRCINA Inserm 1232, CHU Nantes, Nantes, France.
Innovaderm Research, Montréal, Québec, Canada.
Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6.
Scarring is a frequent consequence of acne.
Our objective was to evaluate the effect of up to 48 weeks' treatment with adapalene 0.3%/benzoyl peroxide 2.5% (A0.3/BPO2.5) gel on atrophic scars in moderate or severe acne vulgaris.
In Part 1 of this two-part study, A0.3/BPO2.5 gel or vehicle was applied on each half-face for 24 weeks in a randomized, investigator-blinded, split-face design. Part 2 was a 24-week, open-label extension phase during which A0.3/BPO2.5 gel was applied on both sides of the face. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, local tolerability, and safety.
Of the 45 subjects entering Part 2, 41 completed the 48-week study. At baseline (Part 1), most subjects had moderate acne (93.3%) with mild scars (62.2%). The scar count decrease from baseline was 21.7% at week 24 and 26.9% at week 48 on the half-face treated for 48 weeks with A0.3/BPO2.5. For the half-face treated with vehicle followed by 24 weeks' A0.3/BPO2.5, scar count increased by 16.7% at week 24 (under vehicle) and decreased by 22.7% between weeks 24 and 48. The half-face that received 48 weeks' A0.3/BPO2.5 had a lower final atrophic scar count (mean 8.4 vs. 9.9 for the half-face with 24 weeks' vehicle then 24 weeks' A0.3/BPO2.5) and a higher percentage of SGA clear/almost clear. High reductions in acne lesions between baseline and week 48 were observed for both sides of the face. Long-term treatment with A0.3/BPO2.5 was safe and well-tolerated.
Reductions in atrophic acne scars and acne lesions observed after 24 weeks of treatment with A0.3/BPO2.5 gel were maintained with treatment up to 48 weeks. The additional improvement in atrophic scar count with 48 weeks' A0.3/BPO2.5 treatment, compared to delayed application at 24 weeks, highlights the importance of early initiation of effective acne treatment to prevent and reduce the formation of acne scars.
ClinicalTrials.gov identifier NCT02735421.
痤疮常导致瘢痕形成。
评估过氧苯甲酰 2.5%/阿达帕林 0.3%（A0.3/BPO2.5）凝胶治疗 48 周对中重度寻常性痤疮患者萎缩性瘢痕的疗效。
本研究为两部分、部分随机、研究者设盲、双侧面设计。第 1 部分中，A0.3/BPO2.5 凝胶或赋形剂分别用于每侧面部 24 周。第 2 部分为 24 周开放性扩展阶段，两侧面部均使用 A0.3/BPO2.5 凝胶。评估包括研究者评估的萎缩性痤疮瘢痕计数、瘢痕总体评估（SGA）、痤疮皮损计数、局部耐受性和安全性。
45 例进入第 2 部分的受试者中，41 例完成了 48 周研究。第 1 部分（基线）时，大多数患者痤疮为中重度（93.3%），瘢痕为轻度（62.2%）。第 24 周和第 48 周时，A0.3/BPO2.5 治疗 48 周的半侧面部的瘢痕计数分别减少了 21.7%和 26.9%。而第 24 周时，在使用 A0.3/BPO2.5 治疗前使用赋形剂的半侧面部的瘢痕计数增加了 16.7%，在第 24 周至第 48 周之间减少了 22.7%。接受 48 周 A0.3/BPO2.5 治疗的半侧面部最终的萎缩性瘢痕计数较低（接受 24 周赋形剂治疗后再接受 24 周 A0.3/BPO2.5 治疗的半侧面部为 8.4，而接受 48 周 A0.3/BPO2.5 治疗的半侧面部为 9.9），SGA 改善程度更高（几乎完全清除）。在治疗的第 48 周时，两侧面部的痤疮皮损均有显著减少。长期使用 A0.3/BPO2.5 治疗安全且耐受良好。
A0.3/BPO2.5 凝胶治疗 24 周后观察到的萎缩性痤疮瘢痕和痤疮皮损减少，在治疗 48 周时仍保持稳定。与 24 周时延迟使用相比，48 周 A0.3/BPO2.5 治疗时萎缩性瘢痕计数的额外改善，突出了早期开始有效痤疮治疗以预防和减少痤疮瘢痕形成的重要性。
ClinicalTrials.gov 标识符 NCT02735421。
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