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Completed

NCT Number: NCT05096312

Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

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.

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Key information

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

East Avenue Medical Center

Quezon City, National Capital Region, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Zinc gluconate

Dietary Supplement

oral zinc gluconate 200mg

Other names: Solgar zinc gluconate

Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]

Drug

Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening

Other names: Epiduo Forte

Placebo

Other

contains cornstarch

Primary outcomes

  1. Global Acne Grading System Score

    Time frame: 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)

  2. Inflammatory Score

    Time frame: 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.

Secondary outcomes

  1. Examiner's Assessment Score

    Time frame: at 8 weeks

    examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (≥50%)

  2. Patient's Self-assessment Score

    Time frame: at 8 weeks

    patient's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (≥50%)

Sponsors and collaborators

Lead sponsor

East Avenue Medical Center, Philippines

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2021
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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