Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

NCT04899843 | Completed Phase 2

• 1 other identifier: BSMMU/2021/3959
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

AV Zinc GAGS Serum zinc level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Biochemical assessment and evaluate the adverse effects

  8 weeks

Study Arms (2)

Experimental

ACTIVE COMPARATOR

This arm includes 61 acne vulgaris patients receiving topical retinoids

Dietary Supplement: Zinc sulphate tablet 20 mg

Control

PLACEBO COMPARATOR

This arm includes 61 acne vulgaris patients receiving topical retinoids

Dietary Supplement: Placebo tablet 20 mg

Interventions

Zinc sulphate tablet 20 mg DIETARY_SUPPLEMENT

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

Experimental

Placebo tablet 20 mg DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 11 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy and lactation,
• History of oral contraceptive pills, zinc, and iron intake,
• Suffering from any cosmetic induced acne

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Basic Science and Paraclinical Science of BSMMU

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Prof. Md. Sayedur Rahman, MBBS, Mphil, FCPS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Newly diagnosed Acne vulgaris patients

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 25, 2021
• Study Start: April 27, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

BA (1)