Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial
Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial
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DOI：
10.7860/jcdr/2014/9111.4769
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发表时间：
2014-08-01
影响因子：
0.2
通讯作者：
Mittal, Ravindra
中科院分区：
文献类型：
--
作者：
Bhavsar, Bhavik;Choksi, Bimal;Mittal, Ravindra
背景：面部寻常性痤疮是一种常见的皮肤病，严重影响患者的生活质量、心理社会发展和自尊。纳米乳液凝胶配方据说比常规配方具有各种优点。目的：比较克林霉素纳米乳凝胶制剂与常规制剂治疗面部寻常性痤疮的疗效和安全性。材料和方法：这项前瞻性、主动对照、多中心、IV期临床试验评估了纳米乳液凝胶制剂或常规克林霉素凝胶制剂（作为磷酸盐）1%局部应用，每日两次，随机分配，持续12周。痤疮病变计数（炎性、非炎性和总）和严重程度分级在每月计划的访问中进行，并进行耐受性评估。结果：本试验共纳入200例患者（男性97例）进行意向治疗分析，每组100例。总减少量(69.3比51.9%;p
Background: Acne vulgaris of the face is a common dermatological disease with a significant impact on the quality of life, psychosocial development as well as self-esteem of the patients. Nano emulsion gel formulations are said to have various advantages over the conventional formulations.Aim: The present study was conducted to assess the comparative efficacy and safety of a nano-emulsion gel formulation of clindamycin with its conventional formulation in the treatment of acne vulgaris of the face. M aterials and Methods: This prospective, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by a nano emulsion gel formulation or conventional gel formulation of clindamycin (as phosphate) 1% locally applied twice daily for 12 weeks as per random allocation. Acne lesion counts (inflammatory, non-inflammatory and total) and severity grading were carried out on the monthly scheduled visits along with tolerability assessments.Results: A total of 200 patients (97 males) were included for Intention to Treat analysis in the trial with 100 patients in each group. Reductions in total (69.3 vs. 51.9%; p