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Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

Sponsor
East Avenue Medical Center, Philippines (Other)
Overall Status
Completed
CT.gov ID
NCT05096312
Collaborator
(none)
23
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
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 :
Dec 21, 2018
Actual Primary Completion Date :
Jul 19, 2019
Actual Study Completion Date :
Jul 20, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Global Acne Grading System Score [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 [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 [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 [at 8 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 27 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 East Avenue Medical Center Quezon City Metro Manila Philippines

    Sponsors and Collaborators

    • East Avenue Medical Center, Philippines

    Investigators

    • Principal Investigator: Monique Lianne C. Lim-Ang, MD,MBA,DPDS, East Avenue Medical Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    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:
    Oct 27, 2021
    Last Update Posted:
    May 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Principal Investigator, East Avenue Medical Center, Philippines
    acne vulgaris
    zinc gluconate
    inflammation
    adapalene
    benzoyl peroxide
    Global Acne Grading System
    Additional relevant MeSH terms:
    Acne Vulgaris
    Zinc
    Adapalene
    Adapalene, Benzoyl Peroxide Drug Combination
    Benzoyl Peroxide

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Zinc Gluconate Group Placebo Group
    Arm/Group 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. Zinc gluconate: oral zinc gluconate 200mg 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 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. 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 Placebo: contains cornstarch
    Period Title: Overall Study
    STARTED 11 12
    COMPLETED 8 8
    NOT COMPLETED 3 4

    Baseline Characteristics

    Arm/Group Title Zinc Gluconate Group Placebo Group Total
    Arm/Group 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. Zinc gluconate: oral zinc gluconate 200mg 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 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. 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 Placebo: contains cornstarch Total of all reporting groups
    Overall Participants 8 8 16
    Age (Count of Participants)
    <=18 years
    5
    62.5%
    1
    12.5%
    6
    37.5%
    Between 18 and 65 years
    3
    37.5%
    7
    87.5%
    10
    62.5%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    6
    75%
    6
    75%
    12
    75%
    Male
    2
    25%
    2
    25%
    4
    25%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    8
    100%
    8
    100%
    16
    100%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    Philippines
    8
    100%
    8
    100%
    16
    100%
    Inflammatory Score (units on a scale) [Median (Full Range) ]
    Median (Full Range) [units on a scale]
    70
    48.5
    62.84
    Global Acne Grading System score (units on a scale) [Median (Full Range) ]
    Median (Full Range) [units on a scale]
    32
    30.33
    31.5

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
    Arm/Group Title Zinc Gluconate Group Placebo Group
    Arm/Group 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. Zinc gluconate: oral zinc gluconate 200mg 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 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. 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 Placebo: contains cornstarch
    Measure Participants 8 8
    Initial
    32
    30.33
    4 weeks
    21.67
    27.5
    8 weeks
    14.34
    21.67
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
    Arm/Group Title Zinc Gluconate Group Placebo Group
    Arm/Group 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. Zinc gluconate: oral zinc gluconate 200mg 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 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. 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 Placebo: contains cornstarch
    Measure Participants 8 8
    Initial
    70
    48.5
    4 weeks
    22.67
    47.5
    8 weeks
    8.34
    22.67
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
    Arm/Group Title Zinc Gluconate Group Placebo Group
    Arm/Group 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. Zinc gluconate: oral zinc gluconate 200mg 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 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. 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 Placebo: contains cornstarch
    Measure Participants 8 8
    No Improvement
    0
    0%
    0
    0%
    Slight Improvement (<50%)
    0
    0%
    0
    0%
    Marked Improvement (≥50%)
    8
    100%
    8
    100%
    4. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
    Arm/Group Title Zinc Gluconate Group Placebo Group
    Arm/Group 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. Zinc gluconate: oral zinc gluconate 200mg 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 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. 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 Placebo: contains cornstarch
    Measure Participants 8 8
    No improvement
    0
    0%
    0
    0%
    Slight improvement (<50%)
    0
    0%
    0
    0%
    Marked improvement (≥50%)
    8
    100%
    8
    100%

    Adverse Events

    Time Frame 6 months
    Adverse Event Reporting Description
    Arm/Group Title Zinc Gluconate Group Placebo Group
    Arm/Group 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. Zinc gluconate: oral zinc gluconate 200mg 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 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. 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 Placebo: contains cornstarch
    All Cause Mortality
    Zinc Gluconate Group Placebo Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/11 (0%) 0/12 (0%)
    Serious Adverse Events
    Zinc Gluconate Group Placebo Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/11 (0%) 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Zinc Gluconate Group Placebo Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/11 (9.1%) 0/12 (0%)
    Gastrointestinal disorders
    vomiting 1/11 (9.1%) 1 0/12 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Monqiue Lianne Lim-Ang
    Organization East Avenue Medical Center
    Phone 0287100957
    Email moniquelianne.lim@gmail.com
    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:
    Oct 27, 2021
    Last Update Posted:
    May 11, 2022
    Last Verified:
    Apr 1, 2022