Kantikosum Kornphaka, Chongpison Yuda, Chottawornsak Natcha, Asawanonda Pravit
Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand,
Center of Excellence in Biostatistics, Research Affairs, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Clin Cosmet Investig Dermatol. 2019 Feb 19;12:151-161. doi: 10.2147/CCID.S193730. eCollection 2019.
Acne vulgaris is a common and chronic disease that impacts on physical and psychological perceptions. Cosmeceutical products are widely used as adjunct therapy to standard treatments.
To evaluate the efficacy of cosmeceutical products comprising glycolic acid, salicylic acid, gluconolactone, and licochalcone A as adjunct therapy to adapalene in mild-to-moderate acne vulgaris.
A 28-day, double-blind, within-person comparative study was conducted with a total of 25 subjects. Each participant received two products, consisting of (1) a cosmeceutical product mixed with 0.1% adapalene, and (2) 0.1% adapalene, and was asked to apply them separately on each hemi-side once nightly for 28 days. The number of acne lesions, severity of acne vulgaris, physician's and patient's global assessment of acne severity, visual analog scale of radiance, skin biophysics, safety assessment, and VISIA camera system were evaluated. The primary efficacy outcome was to compare the reduction of inflammatory lesions between two treatments at day 7 by using non-inferiority comparison.
The mean differences of inflammatory lesions reduction at day 7 between the two groups was 0.391 (90% CI = 0.253-0.530). The differences between two groups fell within our acceptable margin for the 90% CI. The spot score from VISIA showed higher statistically significant improvement in the combination side.
The results showed no hindrance of using a cosmeceutical combined with standard treatment. Nevertheless, this cosmeceutical product showed some benefits in reducing complications from acne.
Thai Clinical Trials Registry (primary site), no. TCTR20171031005.
寻常痤疮是一种常见的慢性疾病，会影响身体和心理认知。药妆产品被广泛用作标准治疗的辅助疗法。
评估含有乙醇酸、水杨酸、葡萄糖酸内酯和光甘草定A的药妆产品作为阿达帕林辅助疗法治疗轻至中度寻常痤疮的疗效。
进行了一项为期28天的双盲、自身对照比较研究，共有25名受试者。每位参与者接受两种产品，分别为（1）一种与0.1%阿达帕林混合的药妆产品，以及（2）0.1%阿达帕林，并被要求每晚在每侧半脸分别涂抹一次，持续28天。评估痤疮皮损数量、寻常痤疮严重程度、医生和患者对痤疮严重程度的整体评估、光泽视觉模拟量表、皮肤生物物理学、安全性评估以及VISIA摄像系统。主要疗效指标是通过非劣效性比较，在第7天比较两种治疗方法之间炎症性皮损的减少情况。
两组在第7天炎症性皮损减少的平均差异为0.391（90%CI = 0.253 - 0.530）。两组之间的差异在我们可接受的90%CI范围内。VISIA的斑点评分显示联合用药一侧在统计学上有更高的显著改善。
结果表明药妆产品与标准治疗联合使用没有障碍。尽管如此，这种药妆产品在减少痤疮并发症方面显示出一些益处。
泰国临床试验注册中心（主要站点），编号TCTR20171031005。
