Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

April 18, 2022 updated by: Monique Lianne C. Lim-Ang, MD, MBA, DPDS, East Avenue Medical Center, Philippines

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Metro Manila
      • Quezon City, Metro Manila, Philippines
        • East Avenue Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 27 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zinc gluconate group

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.
Dietary supplement: Zinc gluconate
oral zinc gluconate 200mg
Other Names:
  • Solgar zinc gluconate
Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]
Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening
Other Names:
  • Epiduo Forte
Placebo Comparator: Placebo group
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.
Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]
Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening
Other Names:
  • Epiduo Forte
Other: Placebo
contains cornstarch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
upon enrollment, at 4 weeks, at 8 weeks
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.
upon enrollment, at 4 weeks, at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%)
at 8 weeks
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%)
at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Avenue Medical Center, Philippines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2018

Primary Completion (Actual)

July 19, 2019

Study Completion (Actual)

July 20, 2019

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAMC IERB 2018-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne Vulgaris

Clinical Trials on Zinc gluconate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe