Garofalo Virginia, Cannizzaro Maria Vittoria, Mazzilli Sara, Bianchi Luca, Campione Elena
Division of Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
Clin Cosmet Investig Dermatol. 2019 May 15;12:363-369. doi: 10.2147/CCID.S182317. eCollection 2019.
Acne is a debilitating disorder that requires proper treatment depending on the clinical manifestations and pathogenetic factors, among which hyper-keratinization, seborrhea and bacterial proliferation. Combining active ingredients targeting the different mediators of acne pathogenesis may yield optimal outcomes. The purpose of this study was to evaluate the clinical effectiveness, safety and tolerability of a new topical medical device in cream containing benzoylperoxide 4%, pure retinol 0.05%, palmitate retinol 0.5%, mandelic acid 1% and glycyrrhetic acid on patients with mild acne. Twenty consecutive patients of both sexes with mild acne were included in the study. The topical treatment was self-applied twice a day for 12 weeks. Evaluations included: Global Acne Grading System (GAGS); inflammatory and non-inflammatory lesions count; reflectance confocal microscopy; seborrhea and hydration degree; photographic documentation; a questionnaire to assess tolerability. The GAGS score showed a 39% reduction from T0 to T1 and 69.20% from T0 to T2. The count of comedonic lesions showed a 44% reduction from T0 to T1 and 65% from T0 to T2. The count of papular lesions diminished by 49.4% from T0 to T1 and by 62% from T0 to T2. The count of pustular lesions decreased by 43% from T0 to T1 and by 80% from T0 to T2. Improvement of hydration and a decrease of seborrhea degree were even observed. These clinical results were confirmed by reflectance confocal microscopy exam. The topical medical device has shown to be clinically effective and well tolerated for the treatment of mild acne. Side effects were mild, transient and well tolerated. The results of our study demonstrated a high tolerability of this new combination of benzoylperoxide 4% and retinol. Furthermore, our results suggested that the studied compound could be considered as a "maintenance treatment" after specific pharmacological treatment, even in more severe types of acne.
痤疮是一种使人虚弱的疾病，需要根据临床表现和致病因素进行适当治疗，其中包括过度角化、皮脂溢和细菌增殖。联合使用针对痤疮发病机制不同介质的活性成分可能会产生最佳效果。本研究的目的是评估一种新型外用医疗乳膏器械（含4%过氧化苯甲酰、0.05%纯视黄醇、0.5%视黄醇棕榈酸酯、1%扁桃酸和甘草次酸）对轻度痤疮患者的临床有效性、安全性和耐受性。该研究纳入了20例连续的轻度痤疮男女患者。外用治疗为患者自行每天涂抹两次，持续12周。评估内容包括：全球痤疮分级系统（GAGS）；炎性和非炎性皮损计数；反射式共聚焦显微镜检查；皮脂溢和水合程度；照片记录；一份评估耐受性的问卷。GAGS评分从T0到T1降低了39%，从T0到T2降低了69.20%。粉刺性皮损计数从T0到T1降低了44%，从T0到T2降低了65%。丘疹性皮损计数从T0到T1减少了49.4%，从T0到T2减少了62%。脓疱性皮损计数从T0到T1减少了43%，从T0到T2减少了80%。甚至观察到水合改善和皮脂溢程度降低。这些临床结果通过反射式共聚焦显微镜检查得到证实。该外用医疗器械已显示出对轻度痤疮治疗具有临床有效性且耐受性良好。副作用轻微、短暂且耐受性良好。我们的研究结果表明，这种4%过氧化苯甲酰和视黄醇的新组合具有高耐受性。此外，我们的结果表明，即使对于更严重类型的痤疮，所研究的化合物在特定药物治疗后也可被视为一种“维持治疗”。
