Clinical trial NCT05096312: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: acne vulgaris
zinc gluconate
inflammation
adapalene
benzoyl peroxide
Global Acne Grading System
Lead sponsor: East Avenue Medical Center, Philippines
Sponsor class: OTHER_GOV
First posted: 2021-10-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Global Acne Grading System Score
timeFrame: upon enrollment, at 4 weeks, at 8 weeks
measure: Inflammatory Score
timeFrame: upon enrollment, at 4 weeks, at 8 weeks
Secondary outcomes:
measure: Examiner's Assessment Score
timeFrame: at 8 weeks
measure: Patient's Self-assessment Score
timeFrame: at 8 weeks
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: East Avenue Medical Center
state: Metro Manila
Study officials:
affiliation: East Avenue Medical Center
name: Monique Lianne C. Lim-Ang, MD,MBA,DPDS
role: PRINCIPAL_INVESTIGATOR
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