Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Zinc gluconate; Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]; Placebo
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): oral zinc gluconate 200mg; Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening; contains cornstarch
Other intervention name(s): Solgar zinc gluconate; Epiduo Forte
Intervention MeSH terms: Zinc; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne vulgaris; zinc gluconate; inflammation; adapalene; benzoyl peroxide; Global Acne Grading System