Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04899843
• Other study ID #: BSMMU/2021/3959
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2022
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Dietary Supplement:
• Zinc sulphate tablet 20 mg
Zinc sulphate tablet 20 mg daily orally for 8 weeks along with topical retinoids.
• Placebo tablet 20 mg
Placebo tablet 20 mg daily orally for 8 weeks along with topical retinoids

Locations

Country	Name	City	State
Bangladesh	Basic Science and Paraclinical Science of BSMMU	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acne vulgaris severity score assessment	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	8 weeks
Secondary	Biochemical assessment and evaluate the adverse effects	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.	8 weeks