Comparative Study of Metformin Versus Doxycycline in Moderate to Severe Adult Acne Vulgaris Patients.

February 7, 2024 updated by: Dr. Muhammad Marnush, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Comparative Study of Metformin Versus Doxycycline in Treatment of Moderate to Severe Adult Acne Vulgaris Patients: Multicentre, Randomized, Double-blind Trial.

The goal of this clinical trial is to compare the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not.

Patients will be asked to take doxycycline along with tropical treatment in one group and metformin along with tropical treatment in another group.

Researcher will compare the clinical improvement in two groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Newly diagnosed moderate and severe AV patients diagnosed by a dermatologist

-

Exclusion Criteria:

  • Patients receiving topical retinoids within last two months
  • Pregnancy and lactation
  • History of corticosteroids intake
  • Suffering from malignancy or any cosmetic induced acne

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Metformin 500 mg twice daily along with topical retinoids for 12 weeks
Drug: Metformin and doxycycline
Metformin 500 mg tablet twice daily
Active Comparator: Group B
Doxycycline 100 mg twice daily along with topical retinoids for 12 weeks
Drug: Metformin and doxycycline
Metformin 500 mg tablet twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Acne Grading System (GAGS) Score
Time Frame: 12 weeks
Acne Vulgaris Severity assesment by GAGS score
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Estimated)

February 9, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU/2022/11379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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