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临床试验/NCT04899843
NCT04899843已完成2 期

Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients: A Randomized, Double-Blind, Placebo-Controlled Trial

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2021年4月27日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
122
试验地点
1
主要终点
Acne vulgaris severity score assessment

研究概览

简要总结

The study was 8 weeks, randomized, double-blind, placebo-controlled trial to assess the effect of zinc sulphate on symptoms of mild and moderate acne vulgaris in 122 patients. Participants was assessed at baseline, and 8 weeks. Subjects was randomized to receive either 20 mg elemental zinc daily or 20 mg placebo tablet daily for 8 weeks. The primary outcome was the measure of the GAGS score and the secondary measure includes serum zinc level and evaluate adverse effects.

详细描述

Acne vulgaris (AV) is the eighth most prevalent disease worldwide. Acne is a self-limiting condition, it may cause significant psychological and social problems, depression, disfigurement, and scarring that can persist for a lifetime. Multiple factors contribute to acne pathogenesis including increased sebum production, aberrant keratinization of the pilosebaceous duct, bacteria such as Propionibacterium acnes, hormonal influences, the skin microbiome, and chronic inflammation. Relapse rates in patients with acne after treatment with standard of care vary between 10% and 60%. Recent trials attempted to assess the effect of zinc in reducing the severity of symptoms of acne vulgaris patients. This study evaluates whether there is any role of zinc in reducing acne symptoms between those who did and did not receive zinc in an 8 weeks period. This includes 122 acne vulgaris patients who were recruited from Dermatology and Venereology OPD of BSMMU. Participants took either 20 mg elemental zinc daily in the form of zinc sulphate tablet or 20 mg placebo tablet daily for 8 weeks. Initially, baseline serum zinc level was measured and repeated again after 8 weeks of intervention. A baseline acne symptoms survey was done by GAGS score and also repeated at 8 weeks.

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
Double (Participant, Investigator)

入排标准

年龄范围
11 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed mild and moderate AV patients diagnosed by a dermatologist at the outpatient Department of Dermatology and Venereology,
  • Age: 11-35 years,
  • Gender: Both male and female

排除标准

  • Pregnancy and lactation,
  • History of oral contraceptive pills, zinc, and iron intake,
  • Suffering from any cosmetic induced acne

结局指标

主要结局

Acne vulgaris severity score assessment

时间窗: 8 weeks

Assess the severity score of acne vulgaris symptoms by GAGS(Global Acne Grading System) at baseline, and after 8 weeks. And compare the score between two groups. GAGS scores : 1-18 Mild, 19-30 Moderate

次要结局

  • Biochemical assessment and evaluate the adverse effects(8 weeks)

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Humayra Rumu

Principal investigator

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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