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Completed

NCT Number: NCT04899843

Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

The study was 8 weeks, randomized, double-blind, placebo-controlled trial to assess the effect of zinc sulphate on symptoms of mild and moderate acne vulgaris in 122 patients. Participants was assessed at baseline, and 8 weeks. Subjects was randomized to receive either 20 mg elemental zinc daily or 20 mg placebo tablet daily for 8 weeks. The primary outcome was the measure of the GAGS score and the secondary measure includes serum zinc level and evaluate adverse effects.

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Key information

Age range

11 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Basic Science and Paraclinical Science of BSMMU

Dhaka, Bangladesh

About this study

Acne vulgaris (AV) is the eighth most prevalent disease worldwide. Acne is a self-limiting condition, it may cause significant psychological and social problems, depression, disfigurement, and scarring that can persist for a lifetime. Multiple factors contribute to acne pathogenesis including increased sebum production, aberrant keratinization of the pilosebaceous duct, bacteria such as Propionibacterium acnes, hormonal influences, the skin microbiome, and chronic inflammation. Relapse rates in patients with acne after treatment with standard of care vary between 10% and 60%. Recent trials attempted to assess the effect of zinc in reducing the severity of symptoms of acne vulgaris patients. This study evaluates whether there is any role of zinc in reducing acne symptoms between those who did and did not receive zinc in an 8 weeks period. This includes 122 acne vulgaris patients who were recruited from Dermatology and Venereology OPD of BSMMU. Participants took either 20 mg elemental zinc daily in the form of zinc sulphate tablet or 20 mg placebo tablet daily for 8 weeks. Initially, baseline serum zinc level was measured and repeated again after 8 weeks of intervention. A baseline acne symptoms survey was done by GAGS score and also repeated at 8 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed mild and moderate AV patients diagnosed by a dermatologist at the outpatient Department of Dermatology and Venereology,
  • Age: 11-35 years,
  • Gender: Both male and female

Exclusion criteria

  • Pregnancy and lactation,
  • History of oral contraceptive pills, zinc, and iron intake,
  • Suffering from any cosmetic induced acne

Treatment and study plan

Zinc sulphate tablet 20 mg

Dietary Supplement

Zinc sulphate tablet 20 mg daily orally for 8 weeks along with topical retinoids.

Placebo tablet 20 mg

Dietary Supplement

Placebo tablet 20 mg daily orally for 8 weeks along with topical retinoids

Primary outcomes

  1. Acne vulgaris severity score assessment

    Time frame: 8 weeks

    Assess the severity score of acne vulgaris symptoms by GAGS(Global Acne Grading System) at baseline, and after 8 weeks.

    And compare the score between two groups. GAGS scores : 1-18 Mild, 19-30 Moderate

Secondary outcomes

  1. Biochemical assessment and evaluate the adverse effects

    Time frame: 8 weeks

    Serum zinc level was assessed at baseline and after 8 weeks intervention.Compare the serum zinc level between two group. Adverse effects are evaluated which reported by patients.

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients: A Randomized, Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 25, 2021
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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