Nguyen Nicholas V, Gralla Jane, Abbott James, Bruckner Anna L
Division of Dermatology, Akron Children's Hospital, Akron, OH, USA.
Department of Internal Medicine, Northeast Ohio Medical University, Rootstown, OH, USA.
Pediatr Dermatol. 2018 Mar;35(2):208-212. doi: 10.1111/pde.13404. Epub 2018 Jan 15.
BACKGROUND/OBJECTIVES: There are no reliably effective, well-tolerated topical agents for the treatment of hyperhidrosis. We sought to evaluate the efficacy and tolerability of oxybutynin 3% gel in adolescents and young adults with primary focal hyperhidrosis.
Patients with severe axillary hyperhidrosis were treated with topical oxybutynin 3% gel for 4 weeks. Response to treatment was assessed by calculating change in Hyperhidrosis Disease Severity Score from baseline to weeks 1 and 4. Change in health-related quality of life was assessed using the Children's Dermatology Life Quality Index or the Dermatology Life Quality Index. Adverse effects were evaluated using patient diaries, investigator global review, and physical examination.
Of 10 patients aged 13-24 enrolled, seven completed the study. Of those who completed the study, four (57.1%) reported reduction in axillary Hyperhidrosis Disease Severity Score at week 1 and all seven (100%) at week 4. Six patients (85.7%) reported reduction in Children's Dermatology Life Quality Index or Dermatology Life Quality Index score. Anticholinergic adverse effects were infrequent. The majority of treatment-related adverse events were mild to moderate in severity. One patient experienced a severe adverse event.
Oxybutynin 3% gel reduced hyperhidrosis severity and improved health-related quality of life in this small pilot study. Safety and efficacy should be further evaluated in a large, prospective, placebo-controlled study.
背景/目的:目前尚无可靠有效的、耐受性良好的局部用药用于治疗多汗症。我们旨在评估3%奥昔布宁凝胶治疗青少年和青年原发性局灶性多汗症的疗效和耐受性。
严重腋窝多汗症患者接受3%奥昔布宁凝胶局部治疗4周。通过计算从基线到第1周和第4周多汗症疾病严重程度评分的变化来评估治疗反应。使用儿童皮肤病生活质量指数或皮肤病生活质量指数评估与健康相关的生活质量变化。使用患者日记、研究者整体评估和体格检查评估不良反应。
纳入的10例年龄在13至24岁的患者中,7例完成了研究。在完成研究的患者中,4例(57.1%)报告第1周腋窝多汗症疾病严重程度评分降低,7例(100%)第4周均降低。6例患者(85.7%)报告儿童皮肤病生活质量指数或皮肤病生活质量指数评分降低。抗胆碱能不良反应很少见。大多数与治疗相关的不良事件严重程度为轻至中度。1例患者发生严重不良事件。
在这项小型试点研究中,3%奥昔布宁凝胶降低了多汗症严重程度并改善了与健康相关的生活质量。安全性和有效性应在大型前瞻性安慰剂对照研究中进一步评估。