Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096312
• Other study ID #: EAMC IERB 2018-52
• Status: Completed
• Phase: Phase 4
• Start date: December 21, 2018
• Est. completion date: July 20, 2019

Study information

• Verified date: April 2022
• Source: East Avenue Medical Center, Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 20, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 27 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Dietary Supplement:
• Zinc gluconate
oral zinc gluconate 200mg

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:
• Placebo
contains cornstarch

Locations

Country	Name	City	State
Philippines	East Avenue Medical Center	Quezon City	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
East Avenue Medical Center, Philippines

Country where clinical trial is conducted

Philippines, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Examiner's Assessment Score	examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (=50%)	at 8 weeks
Secondary	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

External Links

•   A Cross-Sectional Study on the Impact of Acne Vulgaris on the Quality of Life among High School Students in Pasig City, Philippines
•   Drug Bank zinc gluconate
•   Evaluation of Severity in Patients of Acne Vulgaris by Global Acne Grading System in Bangladesh
•   Kahalagahan ng zinc sa kalusugan (importance of zinc for health)
•   NIH Zinc fact sheet
•   Serum Trace Elements (Zinc, Copper and Magnesium) Status in Iraqi Patients with Acne Vulgaris: (Case- Controlled Study)
•   summary of zinc
•   Zinc for testosterone
•   Zinc levels in patients with acne vulgaris
•   Zinc status of Filipinos by serum zinc level