Federal University of São Paulo, São Paulo, Brazil.
Clinical Skin Research and Development Center, Pierre Fabre Dermo-Cosmétique, Toulouse, France.
J Eur Acad Dermatol Venereol. 2023 Mar;37 Suppl 2:26-30. doi: 10.1111/jdv.18795.
Acne is a very common condition. Currently, there are relatively few studies available to help guidance-based decisions for its long-term management, especially studies with cosmetic care products. We have developed a skin care product dedicated to adult female acne.
Evaluate the efficacy and tolerance of the test product containing Myrtus communis extract and azelaic acid compared with a light moisturizing cream (LCM) in adult females in the acne maintenance phase.
A clinical study was conducted as a Brazilian, multicentre, randomized, investigator-blinded trial in adult females with clear or almost clear facial acne after anti-acne treatment. The test group (26 subjects) applied the test product and the comparative product group (27 subjects) applied LCM. Both groups applied the products twice daily on the whole face. Subjects were evaluated every 4 weeks over 16 weeks. Efficacy was evaluated according to acne relapse; Investigator's Global Assessment (IGA); acne lesions counting; AcneQoL questionnaire; Subject Global change Assessment (SGA) of acne severity; and the number of Post-Inflammatory Hyperpigmentation (PIH) and Post-Inflammatory Erythema (PIE) lesions. Tolerance was assessed according to a 5-point scale.
Over 16 weeks, the number of acne relapse was more than double in the comparator compared to the test product group (eight subjects vs. three subjects respectively). There was no statistical difference in the evolution of the mean IGA from baseline between the two groups; however, 85% of subjects were assessed as clear or almost clear in the test product group and 67% in the comparative group.
This study demonstrated the effectiveness topical application of the test product compared to LCM on acne severity in the maintenance phase of adult female acne. Efficacy results after 16 weeks suggested a trend to limit acne relapses and a benefit of the test product in maintaining long-term remission.
痤疮是一种非常常见的病症。目前，很少有研究可以为其长期管理提供指导决策，尤其是涉及化妆品护理产品的研究。我们开发了一种专门针对成年女性痤疮的护肤产品。
评估含有桃金娘提取物和壬二酸的测试产品与轻度保湿霜（LCM）在痤疮维持阶段对成年女性的疗效和耐受性。
在巴西进行了一项多中心、随机、研究者盲法临床试验，纳入了痤疮治疗后面部痤疮消退或几乎消退的成年女性。试验组（26 例）应用测试产品，对照组（27 例）应用 LCM。两组均在整个面部每天应用两次产品。在 16 周内，每 4 周评估一次疗效。根据痤疮复发情况、研究者整体评估（IGA）、痤疮皮损计数、痤疮生活质量问卷（AcneQoL）、患者整体评估（SGA）的痤疮严重程度和炎症后色素沉着（PIH）和炎症后红斑（PIE）皮损数量评估疗效。根据 5 分制评估耐受性。
在 16 周内，对照组的痤疮复发人数是试验组的两倍多（分别为 8 例和 3 例）。两组间从基线开始的 IGA 均值的演变无统计学差异；然而，试验组 85%的患者被评估为痤疮消退或几乎消退，而对照组为 67%。
与 LCM 相比，本研究表明该测试产品在治疗成年女性痤疮维持阶段的严重程度方面具有有效性。16 周后的疗效结果表明，该测试产品有抑制痤疮复发的趋势，并能长期维持缓解。
