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Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Zinc sulphate tablet 20 mg
Placebo tablet 20 mg
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring AV Zinc GAGS Serum zinc level

Eligibility Criteria

11 Years - 35 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Basic Science and Paraclinical Science of BSMMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

This arm includes 61 acne vulgaris patients receiving topical retinoids

This arm includes 61 acne vulgaris patients receiving topical retinoids

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
May 11, 2021
Last Updated
March 6, 2022
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT04899843
Brief Title
Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients
Official Title
Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients: A Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
AV Zinc GAGS Serum zinc level

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Newly diagnosed Acne vulgaris patients
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Active Comparator
Arm Description
This arm includes 61 acne vulgaris patients receiving topical retinoids
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This arm includes 61 acne vulgaris patients receiving topical retinoids
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc sulphate tablet 20 mg
Intervention Description
Zinc sulphate tablet 20 mg daily orally for 8 weeks along with topical retinoids.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tablet 20 mg
Intervention Description
Placebo tablet 20 mg daily orally for 8 weeks along with topical retinoids
Primary Outcome Measure Information:
Title
Acne vulgaris severity score assessment
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Biochemical assessment and evaluate the adverse effects
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Md. Sayedur Rahman, MBBS, Mphil, FCPS
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Study Chair
Facility Information:
Facility Name
Basic Science and Paraclinical Science of BSMMU
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

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Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

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