Effectiveness of Zinc Supplementation With Topical Retino... | NCT04899843

Studies
Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

NCT04899843

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status

Completed

Last Update Posted

Mar 21, 2022Actual

Enrollment

122Actual

Phase

Phase 2

Conditions

Acne Vulgaris

Interventions

Zinc sulphate tablet 20 mg
Placebo tablet 20 mg

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2021Actual

Primary Completion Date

Nov 30, 2021Actual

Completion Date

Nov 30, 2021Actual

First Submitted Date

May 11, 2021

First Submission Date that Met QC Criteria

May 19, 2021

First Posted Date

May 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2022

Last Update Posted Date

Mar 21, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Humayra Rumu, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPrincipal Investigator

Lead Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Zinc sulphate tablet 20 mg	Dietary Supplement	Zinc sulphate tablet 20 mg daily orally for 8 weeks along with topical retinoids.	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prof. Md. Sayedur Rahman, MBBS, Mphil, FCPS	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Basic Science and Paraclinical Science of BSMMU		Dhaka			Bangladesh

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019287	Zinc Sulfate

Ancestor Terms

ID	Term
D013431	Sulfates
D013464	Sulfuric Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided