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临床试验/NCT05926869
NCT05926869已完成2 期

Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris

Jinnah Postgraduate Medical Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris

研究概览

简要总结

Acne vulgaris (AV) is a disease of the pilosebaceous unit that causes noninflammatory lesions (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and varying degrees of scarring. The key pathogenic processes includes alteration of follicular keratinization that leads to comedones; increased and altered sebum production under androgen control; follicular colonization by Propionibacterium acnes; . The role of topical antibiotics in treating acne is well established. Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. The extensive use of antibiotics in acne has lead to the development of resistance to antimicrobial therapy. Dapsone is known to have antibacterial as well as anti-inflammatory action which may help in reduction of acne.

详细描述

Topical Dapsone 5% gel contains sulfone and has an advanced solvent micro particulate delivery system that enables penetration of stratum corneum . It is a new topical drug used in the treatment of Moderate Acne Vulgaris.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • moderate acne vulgaris
  • either gender
  • 20 to 50 yrs

排除标准

  • systemic treatment taken
  • pregnant or lactating women
  • hematological abnormalities

研究组 & 干预措施

Group A Clindamycin gel

Experimental

干预措施: Clindamycin and Dapsone gel for 03 months (Drug)

Group B Dapsone gel

Experimental

干预措施: Clindamycin and Dapsone gel for 03 months (Drug)

结局指标

主要结局

Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris

时间窗: It will be assessed upto 03 months

Efficacy will be assessed using Global Acne Grading Sore ( GAGS ). For GAGS (Score 1-18 = mild, score 19-30 = moderate, score 31-38 = severe). Mean difference of GAGs score before and after the treatment will be calculated.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Parisa Sanawar

Principal Investigator

Jinnah Postgraduate Medical Centre

研究点 (1)

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