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Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Zinc gluconate
Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]
Placebo
Sponsored by
East Avenue Medical Center, Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris, zinc gluconate, inflammation, adapalene, benzoyl peroxide, Global Acne Grading System

Eligibility Criteria

18 Years - 27 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Avenue Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zinc gluconate group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Global Acne Grading System Score
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
changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.

Secondary Outcome Measures

Examiner's Assessment Score
examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (≥50%)
Patient's Self-assessment Score
patient's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (≥50%)

Full Information

First Posted
October 14, 2021
Last Updated
April 18, 2022
Sponsor
East Avenue Medical Center, Philippines
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1. Study Identification

Unique Protocol Identification Number
NCT05096312
Brief Title
Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients
Official Title
A Randomized, Double Blind, Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Avenue Medical Center, Philippines

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris, zinc gluconate, inflammation, adapalene, benzoyl peroxide, Global Acne Grading System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc gluconate group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc gluconate
Other Intervention Name(s)
Solgar zinc gluconate
Intervention Description
oral zinc gluconate 200mg
Intervention Type
Drug
Intervention Name(s)
Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]
Other Intervention Name(s)
Epiduo Forte
Intervention Description
Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
contains cornstarch
Primary Outcome Measure Information:
Title
Global Acne Grading System Score
Description
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)
Time Frame
upon enrollment, at 4 weeks, at 8 weeks
Title
Inflammatory Score
Description
changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.
Time Frame
upon enrollment, at 4 weeks, at 8 weeks
Secondary Outcome Measure Information:
Title
Examiner's Assessment Score
Description
examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (≥50%)
Time Frame
at 8 weeks
Title
Patient's Self-assessment Score
Description
patient's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (≥50%)
Time Frame
at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique Lianne C. Lim-Ang, MD,MBA,DPDS
Organizational Affiliation
East Avenue Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Avenue Medical Center
City
Quezon City
State/Province
Metro Manila
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://ods.od.nih.gov/factsheets/Zinc-HealthProfessional/
Description
NIH Zinc fact sheet
URL
https://go.drugbank.com/drugs/DB11248
Description
Drug Bank zinc gluconate
URL
https://examine.com/supplements/zinc/
Description
summary of zinc
URL
https://supplementsinreview.com/testosterone/zinc-testosterone/
Description
Zinc for testosterone
URL
https://philjournalsci.dost.gov.ph/home-1/43-vol-144-no-2-december-2015/540-zinc-status-of-filipinos-by-serum-zinc-level
Description
Zinc status of Filipinos by serum zinc level
URL
https://bijps.uobaghdad.edu.iq/index.php/bijps/article/view/474
Description
Serum Trace Elements (Zinc, Copper and Magnesium) Status in Iraqi Patients with Acne Vulgaris: (Case- Controlled Study)
URL
http://cms.galenos.com.tr/Uploads/Article_32246/jtad-1-0-En.pdf
Description
Zinc levels in patients with acne vulgaris
URL
http://scinet.science.ph/union/Downloads/Fil-361265_361265.pdf
Description
A Cross-Sectional Study on the Impact of Acne Vulgaris on the Quality of Life among High School Students in Pasig City, Philippines

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Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

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