Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Dietary Supplement: Zinc gluconate
* Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zinc gluconate group<br>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<br>* oral zinc gluconate 200mg<br>* Other names: Solgar zinc gluconate;Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]<br>* Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening<br>* Other names: Epiduo Forte;|
| Placebo Comparator: Placebo group<br>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]<br>* Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening<br>* Other names: Epiduo Forte;Other: Placebo<br>* contains cornstarch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | upon enrollment, at 4 weeks, at 8 weeks | 
| Inflammatory Score | 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 | 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 | patient's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (≥50%) | at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris, zinc gluconate, inflammation, adapalene, benzoyl peroxide, Global Acne Grading System