Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Dietary Supplement: Zinc sulphate tablet 20 mg; Dietary Supplement: Placebo tablet 20 mg

• Registration Number: NCT04899843
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-04-27
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-25
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-06
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Zinc sulphate tablet 20 mg	This arm includes 61 acne vulgaris patients receiving topical retinoids
Control	Placebo tablet 20 mg	This arm includes 61 acne vulgaris patients receiving topical retinoids

Primary Outcome Measures

Name	Time	Method
Acne vulgaris severity score assessment	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 Outcome Measures

Name	Time	Method
Biochemical assessment and evaluate the adverse effects	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.

Trial Locations

Locations (1)

Basic Science and Paraclinical Science of BSMMU; 🇧🇩 Dhaka, Bangladesh