Marshall-Hudson Allyson, Tuley Michael, Damstra Maureen, Dosik Jonathan S, Myntti Matthew F, Porral Dianne, Palomo Janel
Drs. Marshall-Hudson, Tuley, and Dosik and Ms. Damstra are with TKL Research, Inc. in Fair Lawn, New Jersey.
Dr. Myntti and Ms. Porral and Ms. Palomo are with Next Science, LLC in Jacksonville, Florida.
J Clin Aesthet Dermatol. 2023 Apr;16(4):43-52.
The primary aim of this study was to assess the change in acne lesions and severity within all treatment groups over the course of a six-month study.
This was a six-month, multisite, randomized, double-blind, controlled study in female subjects with mild-to-moderate acne to assess the clinical and psychological outcomes of treatment with biofilm disrupting acne cream 2x, biofilm disrupting acne cream 1x, biofilm disrupting acne cream without salicylic acid, 2.5% benzoyl peroxide (BPO) gel, and placebo. Subjects applied the assigned product to their face twice daily and were evaluated for clinical acne and quality of life outcomes at baseline and after six, 12, 18, and 24 weeks of treatment.
After 24 weeks of use, subjects treated with biofilm disrupting acne cream 2x had a significantly greater improvement in the Investigator Global Assessment (IGA), compared to those treated with 2.5% BPO gel. Based on dermatologic assessments, biofilm disrupting acne cream 2x, biofilm disrupting acne cream 1x, biofilm disrupting acne cream without salicylic acid, and placebo control were associated with less erythema and dryness, compared to 2.5% BPO gel.
Assessments within this study had the potential for subjective differences due to variability between evaluators.
Biofilm disrupting acne cream 2x and biofilm disrupting acne cream 1x provided equivalent efficacy to 2.5% BPO gel with less of the adverse effects commonly associated with BPO, such as erythema and dryness. Both the biofilm disrupting acne cream without salicylic acid and the placebo control were associated with mild improvements to acne symptoms over the course of the 24-week study.
ClinicalTrials.gov, NCT03106766.
本研究的主要目的是评估在为期六个月的研究过程中，所有治疗组痤疮皮损和严重程度的变化。
这是一项为期六个月、多中心、随机、双盲、对照研究，针对患有轻至中度痤疮的女性受试者，以评估使用2倍浓度生物膜破坏型痤疮乳膏、1倍浓度生物膜破坏型痤疮乳膏、不含水杨酸的生物膜破坏型痤疮乳膏、2.5%过氧化苯甲酰（BPO）凝胶和安慰剂进行治疗的临床和心理结果。受试者每天两次将指定产品涂抹于面部，并在基线以及治疗6周、12周、18周和24周后接受临床痤疮和生活质量结果评估。
使用24周后，与使用2.5%BPO凝胶治疗的受试者相比，使用2倍浓度生物膜破坏型痤疮乳膏治疗的受试者在研究者整体评估（IGA）方面有显著更大的改善。根据皮肤科评估，与2.5%BPO凝胶相比，2倍浓度生物膜破坏型痤疮乳膏、1倍浓度生物膜破坏型痤疮乳膏、不含水杨酸的生物膜破坏型痤疮乳膏和安慰剂对照与更少的红斑和干燥相关。
由于评估者之间存在差异，本研究中的评估存在主观差异的可能性。
2倍浓度生物膜破坏型痤疮乳膏和1倍浓度生物膜破坏型痤疮乳膏提供了与2.5%BPO凝胶相当的疗效，且与BPO常见的不良反应（如红斑和干燥）较少。在为期24周的研究过程中，不含水杨酸的生物膜破坏型痤疮乳膏和安慰剂对照均与痤疮症状的轻度改善相关。
ClinicalTrials.gov，NCT03106766。
