背景:痤疮诱导的色素沉着过度(AIH)可能伴随所有皮肤光型的寻常痤疮(AV)炎症。Trifarotene已在体内显示出脱色特性。这项研究评估了trifarotene加护肤,因为人们越来越认识到整体AV管理应包括护肤和治疗。
方法:这是第四阶段双盲,平行组研究的患者(13-35岁)与中度AV和AIH治疗的三法罗汀(N=60)或载体(N=63)加护肤方案(保湿剂,洁面乳,和防晒霜)持续24周。评估包括AIH总体疾病严重程度(ODS)评分,后房室色素沉着过度指数(PAHPI),退出面试,摄影,和痤疮评估。包括标准安全性评估。
结果:Trifarotene50μg/g乳膏在ODS评分与媒介物(-1.6vs.-1.1,P=0.03),在第12周,但在第24周(主要终点),组间得分相当。Trifarotene在第24周的PAHPI评分降低更好(-18.9%vs.-11.3%车辆,P<0.01)。在第12周时,trifarotene的损伤计数减少高于溶媒(P<0.001)和第24周(P<0.05),在第12周(P<0.05)和第24周(P<0.05),IGA成功率与车辆的比较也是如此。患者一致认为护肤方案有助于减少刺激,使治疗依从性更容易。摄影显示所有皮肤类型的色素沉着和红斑的改善。与trifarotene相比,车辆组的AE更常见(30.2vs.16.7%,分别)。
结论:在所有皮肤照型中,在第12周和第24周,使用trifarotene的ODS和PAHPI评分分别有更快的改善.trifarotene和护肤的组合与高患者满意度和对治疗方案的依从性相关。
BACKGROUND: Acne-induced hyperpigmentation (AIH) may accompany acne vulgaris (AV) inflammation in all skin phototypes. Trifarotene has shown depigmenting properties in vivo. This
study evaluated trifarotene plus skincare because it is increasingly recognized that holistic AV management should include skincare and treatments.
METHODS: This is a phase IV double-blind, parallel-group
study of patients (13-35 years) with moderate AV and AIH treated with trifarotene (N = 60) or vehicle (N = 63) plus skincare regimen (moisturizer, cleanser, and sunscreen) for 24 weeks. Assessments included the AIH overall disease severity (ODS) score, post-AV hyperpigmentation index (PAHPI), exit interviews, photography, and acne assessments. Standard safety assessments were included.
RESULTS: Trifarotene 50 μg/g cream improved significantly from baseline in ODS score versus vehicle (-1.6 vs. -1.1, P = 0.03) at Week 12, but scores were comparable between groups at Week 24 (primary endpoint). Trifarotene had a better reduction in PAHPI score at Week 24 (-18.9% vs. -11.3% vehicle, P < 0.01). Lesion count reductions were higher with trifarotene at Week 12 versus vehicle (P < 0.001) and at Week 24 (P < 0.05), as were IGA success rates versus vehicle at Weeks 12 (P < 0.05) and 24 (P < 0.05). Patients agreed that the skincare regimen contributed to less irritation, making treatment adherence easier. Photography showed improvements in pigmentation and erythema across all skin types. AEs were more common in the vehicle group versus trifarotene (30.2 vs. 16.7%, respectively).
CONCLUSIONS: In all skin phototypes, there was more rapid improvement in the ODS and PAHPI scores with trifarotene by Weeks 12 and 24, respectively. The combination of trifarotene and skincare correlated with high patient satisfaction and adherence to the treatment protocol.