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Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05096312
Recruitment Status : Completed
First Posted : October 27, 2021
Results First Posted : April 13, 2022
Last Update Posted : May 11, 2022
Sponsor:
Information provided by (Responsible Party):
Monique Lianne C. Lim-Ang, MD, MBA, DPDS, East Avenue Medical Center, Philippines

Brief 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.


Condition or disease Intervention/treatment Phase
Acne Vulgaris Dietary Supplement: Zinc gluconate Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo] Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients
Actual Study Start Date : December 21, 2018
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : July 20, 2019


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 Name: 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 Name: 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 Name: Epiduo Forte

Other: Placebo
contains cornstarch




Primary Outcome Measures :
  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 Outcome Measures :
  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%)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 27 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05096312


Locations
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Philippines
East Avenue Medical Center
Quezon City, Metro Manila, Philippines
Sponsors and Collaborators
East Avenue Medical Center, Philippines
Investigators
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Principal Investigator: Monique Lianne C. Lim-Ang, MD,MBA,DPDS East Avenue Medical Center
  Study Documents (Full-Text)

Documents provided by Monique Lianne C. Lim-Ang, MD, MBA, DPDS, East Avenue Medical Center, Philippines:
Additional Information:
Publications:

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Responsible Party: Monique Lianne C. Lim-Ang, MD, MBA, DPDS, Principal Investigator, East Avenue Medical Center, Philippines
ClinicalTrials.gov Identifier: NCT05096312    
Other Study ID Numbers: EAMC IERB 2018-52
First Posted: October 27, 2021    Key Record Dates
Results First Posted: April 13, 2022
Last Update Posted: May 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Monique Lianne C. Lim-Ang, MD, MBA, DPDS, East Avenue Medical Center, Philippines:
acne vulgaris
zinc gluconate
inflammation
adapalene
benzoyl peroxide
Global Acne Grading System
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Zinc
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
Benzoyl Peroxide
Trace Elements
Micronutrients
Physiological Effects of Drugs
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents