Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2021-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Newly diagnosed Acne vulgaris patients

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental

This arm includes 61 acne vulgaris patients receiving topical retinoids

Group Type ACTIVE_COMPARATOR

Zinc sulphate tablet 20 mg

Intervention Type DIETARY_SUPPLEMENT

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

Control

This arm includes 61 acne vulgaris patients receiving topical retinoids

Group Type PLACEBO_COMPARATOR

Placebo tablet 20 mg

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Zinc sulphate tablet 20 mg

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

Intervention Type DIETARY_SUPPLEMENT

Placebo tablet 20 mg

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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