Gold Michael H, Bridges Tancy, Avakian Edward V, Plaum Stefan, Fleischer Alan B, Hardas Bhushan
Gold Skin Care Center and Tennessee Clinical Research Center, Nashville, TN, USA.
J Drugs Dermatol. 2012 Apr;11(4):514-8.
Topical antifungal treatment is a mainstay of therapy for Seborrehic Dermatitis (SD). Although the amidazole and ciclopyridine antifungals have been extensively studied, few clinical efficacy data are available for topical allylamine therapy in SD. The objective of this open-label exploratory study was to evaluate the efficacy and safety of natifine HCl 1% gel applied twice daily for 4 weeks, as topical treatment of moderate SD of the scalp. Nine subjects (5 men, 4 women) with a mean age of 56 (33-81) years with SD of the scalp were enrolled and made 4 visits to the site. At Visit 1 (Week 0), subjects were screened, enrolled, baseline efficacy data were obtained, and treatment was initiated. Subjects returned at Week 2, Week 4 (end of treatment), and Week 6 for efficacy and safety assessments. Efficacy was evaluated by changes from baseline in investigator-rated scores on 0-5-grade scales: (1) SD Global Evaluation Scale (SDGES), (2) Erythema Severity Scale, (3) Scaling Severity Scale, (4) % Scalp Involvement Scale, and subject-rated scores on the (4) Itching Severity Scale, and (5) Global Improvement Scale, where 0=none and 5=most severe. Mean severity scores for the SDGES and % Scalp Involvement scales progressively declined (improved) 66% and 54% from respective baseline levels at Week 6. Mean erythema rating decreased 38% from baseline and scaling decreased 50% from baseline by Weeks 4 and 6. Itching improved in 5 of 9 (56%) subjects by the end of treatment. A total of 8 of 9 (89%) subjects rated their symptoms as improved from baseline at the end of treatment and Week 6. There were no treatment-related adverse events during the study. These results suggest that naftifine 1% gel applied twice daily for 4 weeks is effective and safe topical treatment for moderate SD of the scalp.
局部抗真菌治疗是脂溢性皮炎（SD）治疗的主要手段。尽管咪唑类和环吡酮类抗真菌药物已得到广泛研究，但关于局部使用烯丙胺类药物治疗SD的临床疗效数据却很少。这项开放标签探索性研究的目的是评估每日两次外用1%盐酸萘替芬凝胶，持续4周治疗头皮中度SD的疗效和安全性。招募了9名头皮患有SD的受试者（5名男性，4名女性），平均年龄56岁（33 - 81岁），并到研究地点进行4次访视。在第1次访视（第0周）时，对受试者进行筛查、入组，获取基线疗效数据并开始治疗。受试者在第2周、第4周（治疗结束时）和第6周返回进行疗效和安全性评估。疗效通过0 - 5级量表中研究者评定分数相对于基线的变化来评估：（1）SD整体评估量表（SDGES），（2）红斑严重程度量表，（3）脱屑严重程度量表，（4）头皮受累百分比量表，以及受试者评定的（4）瘙痒严重程度量表和（5）整体改善量表，其中0 =无，5 =最严重。在第6周时，SDGES和头皮受累百分比量表的平均严重程度评分相对于各自的基线水平分别下降（改善）了66%和54%。到第4周和第6周时，平均红斑评分较基线下降了38%，脱屑较基线下降了50%。治疗结束时，9名受试者中有5名（56%）瘙痒症状有所改善。9名受试者中有8名（89%）在治疗结束时和第6周时将其症状评定为较基线有所改善。研究期间未出现与治疗相关的不良事件。这些结果表明，每日两次外用1%萘替芬凝胶，持续4周是治疗头皮中度SD的有效且安全的局部治疗方法。
