Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Dietary Supplement: Placebo tablet 20 mg; Dietary Supplement: Zinc sulphate tablet 20 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04899843

BSMMU/2021/3959

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 11 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups, including a placebo group

Experimental

Active Comparator group

Description:

This arm includes 61 acne vulgaris patients receiving topical retinoids

Treatment:

Dietary Supplement: Zinc sulphate tablet 20 mg

Control

Placebo Comparator group

Description:

This arm includes 61 acne vulgaris patients receiving topical retinoids

Treatment:

Dietary Supplement: Placebo tablet 20 mg