Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)
Overall Status
Completed
CT.gov ID
NCT04899843
Collaborator
(none)
122
1
2
7.1
17.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Zinc sulphate tablet 20 mg
  • Dietary Supplement: Placebo tablet 20 mg
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Newly diagnosed Acne vulgaris patientsNewly diagnosed Acne vulgaris patients
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients: A Randomized, Double-Blind, Placebo-Controlled Trial
Actual Study Start Date :
Apr 27, 2021
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Experimental

This arm includes 61 acne vulgaris patients receiving topical retinoids

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

Placebo Comparator: Control

This arm includes 61 acne vulgaris patients receiving topical retinoids

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Basic Science and Paraclinical Science of BSMMU Dhaka Bangladesh

Sponsors and Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Study Chair: Prof. Md. Sayedur Rahman, MBBS, Mphil, FCPS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Humayra Rumu, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT04899843
Other Study ID Numbers:
  • BSMMU/2021/3959
First Posted:
May 25, 2021
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Humayra Rumu, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2022