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临床试验/NCT05096312
NCT05096312已完成4 期

A Randomized, Double Blind, Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients

East Avenue Medical Center, Philippines1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年12月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Global Acne Grading System Score

研究概览

简要总结

Acne Vulgaris is one of the most common dermatologic diagnoses requiring long-term maintenance therapy. Promising results of oral zinc gluconate in improving acne vulgaris has been described.

A randomized, double blind, placebo-controlled clinical trial was utilized for this study with the objective to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients as measured by the inflammatory score and Global Acne Grading System (GAGS) score.

详细描述

Acne has four main pathogenic contributors: follicular hyperkeratinization, increased sebum production, Propionibacterium acnes (P. acnes) within the follicle, and inflammation. Treatment options for acne vulgaris include benzoyl peroxide, topical and oral retinoids, topical and oral antimicrobials, oral corticosteroids, and physical modalities such as acne surgery, laser and light therapy. Reports show that antibiotic resistance is a growing issue in the treatment regimen of acne vulgaris, making it less and less suitable for long-term treatment, hence other options that can be substitutes or adjuncts to treatment may be useful in this condition. For long-term or maintenance therapy, physicians should consider effectivity, cost, and adverse effects. Several studies have explored the effect of oral zinc on acne vulgaris. Since zinc is more cost-effective and has less adverse effects compared to most antibiotics, this may prove helpful for the Filipino patient in terms of safety and economy for long-term therapy.

The aim of this study is to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients, to determine the demographic and clinical profile of Acne Vulgaris patients, to determine the disease activity measured by the inflammatory score and GAGS score of acne vulgaris patients on initial consult, at 4 weeks, and at 8 weeks, and to determine if there is a significant difference in disease activity as measured by the inflammatory score and GAGS score among acne vulgaris patients given placebo and oral zinc gluconate.

A randomized, double blind, placebo-controlled clinical trial was utilized. Adults with moderate to severe acne vulgaris were included in the study. Patients were evaluated using the inflammatory score and Global Acne Grading System (GAGS) at the start, at midpoint, and at the end of the trial. One group of participants received zinc gluconate supplementation and another group received placebo for 60 days. All participants received topical adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening. Improvement in acne severity was then determined and compared.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 27 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Filipino patients, aged 18-27 years old
  • New patients diagnosed with Acne Vulgaris with a Global Acne Grading System score of at least 19
  • Able to read and write in English or Tagalog
  • Seen at the Dermatology out-patient clinic of East Avenue Medical Center

排除标准

  • Patients with other chronic dermatoses or systemic disease
  • Taking oral supplements or medications within the past 4 weeks
  • Patients who are pregnant or lactating

研究组 & 干预措施

Zinc gluconate group

Active Comparator

interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.

Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.

干预措施: Zinc gluconate (Dietary Supplement)

Zinc gluconate group

Active Comparator

interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.

Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.

干预措施: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo] (Drug)

Placebo group

Placebo Comparator

interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.

干预措施: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo] (Drug)

Placebo group

Placebo Comparator

interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.

干预措施: Placebo (Other)

结局指标

主要结局

Global Acne Grading System Score

时间窗: upon enrollment, at 4 weeks, at 8 weeks

changes in Global Acne Grading System (GAGS) score. Minimum score is 0, maximum score is 44. Cut off scores are as follows: no lesion (0), mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39)

Inflammatory Score

时间窗: upon enrollment, at 4 weeks, at 8 weeks

changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.

次要结局

  • Examiner's Assessment Score(at 8 weeks)
  • Patient's Self-assessment Score(at 8 weeks)

研究者

发起方
East Avenue Medical Center, Philippines
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Monique Lianne C. Lim-Ang, MD, MBA, DPDS

Principal Investigator

East Avenue Medical Center, Philippines

研究点 (1)

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