Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

Last updated: April 18, 2022
Sponsor: East Avenue Medical Center, Philippines
Overall Status: Completed

Phase

4

Condition

Acne

Scalp Disorders

Rash

Treatment

N/A

Clinical Study ID

NCT05096312
EAMC IERB 2018-52
  • Ages 18-27
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 23
Study Start date:
December 21, 2018
Estimated Completion Date:
July 20, 2019

Study Description

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.

Connect with a study center

  • East Avenue Medical Center

    Quezon City, Metro Manila
    Philippines

    Site Not Available

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