Efficacy of Oral Metformin vs Oral Doxycycline in Treating Acne Vulgaris

January 14, 2026 updated by: Ghurki Trust and Teaching Hospital

The goal of the clinical trial is to learn if oral metformin works to treat moderate to severe acne vulgaris.

Investigators will compare this drug to oral doxycycline to see if this drug works to treat acne. All participants will be divided into two groups.

Group A will be given oral Metformin 500 mg to be taken twice daily, while Group B patients will be given oral Doxycycline 100 mg once daily. They will be assessed by the scoring method Total Lesion Count (TLC) and the Global Acne Grading System (GAGS) at each follow-up (i.e., at 0, 8, and 12 weeks). Efficacy will be measured by using the scoring system GAGS, TLC. The final assessment will be done at the 12th-week follow-up.

A total of 68 patients fulfilling the inclusion criteria are enrolled in the study. The efficacy of oral metformin vs oral doxycycline will be measured in all selected patients suffering from acne vulgaris by estimating improvement in the total lesion count (TLC) and the Global Acne Grading (GAGS) assessment score at each follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acne vulgaris is a common, long-standing inflammatory condition affecting the pilosebaceous unit. Its main features include follicular plugging and raised inflammatory lesions (papules, pustules, and nodules) and scars (1). Nearly half of the teenagers with acne still experience symptoms as adults. Approximately 70-80% of teenagers have acne (2). In some patients acne can remain as an unremitting disease and cause prolonged psychiatric, psychosocial, and physical consequences.

The development of acne results from a complex series of events occurring within the pilosebaceous unit. (3), encompassing various factors such as pronounced sebum production and modifications in its fatty acid composition. Fluctuations in hormones, increased follicular keratinization (4), and disturbances in both innate and adaptive immune system responses are observed. Together, these complex processes disrupt the normal functioning of the pilosebaceous unit and cause follicular damage; thus, they increase sebum production, fatty acids, and lipids in the skin layer, and they will produce inflammatory and noninflammatory lesions.

Reducing scarring and psychological effects, as well as giving the patient the best possible appearance, are the main objectives of treatment. Treatment goals include preventing follicular hyperkeratosis and preventing the release of fatty acids and sebum, thus decreasing the production of comedones. There are numerous topical and systemic treatment modalities available for acne vulgaris. Commonly prescribed topical therapies for mild acne consist of benzoyl peroxide, retinoids, salicylic acid, azelaic acid, clindamycin, and 5% dapsone (5). Systemic therapeutic approaches for acne that have moderate to severe intensity encompass isotretinoin, tetracycline, doxycycline, metformin, and hormonal therapies. including oral contraceptives and antiandrogens (6). Lasers and light-based therapies can also be used for noninflammatory or mildly inflammatory acne Emerging evidence suggests it is strongly associated with insulin resistance. Increased levels of insulin in the bloodstream, known as hyperinsulinemia, cause an increase in insulin-like growth factor-1 (IGF-1) concentrations accompanied by a decrease in levels of IGFBP3. (insulin-like growth factor binding protein 3 (7). This affects keratinocyte growth and death directly and may cause the release of growth hormone, glucocorticoids, and androgen factors associated with the development of acne.

This novel research will evaluate and compare the therapeutic outcomes of oral metformin and oral doxycycline in the management of moderate to severe acne vulgaris within the Pakistani population.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Ghurki Trust Teaching Hospital

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • •Age: 12 years-40 years old

    • Gender: Both Female & Male.
    • Moderate to severe Acne vulgaris (II and III)
    • Able to complete monthly treatment for 12th week
    • Noninflammatory acne

Exclusion Criteria:

  • Hypersensitivity or allergic to doxycycline and metformin.
  • History of taking systemic medications one month prior.
  • Pregnancy and lactation.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group: Group A
Group A will receive oral tablet Metformin 500mg twice daily
Drug: oral metformin
Intervention group will recieve oral tablet Metformin 500mg twice daily
Active Comparator: Control Group: Group B
Group B will receive oral tablet Doxycycline 100mg once daily
Drug: Oral doxycycline
Group B will receive oral tablet Doxycycline 100mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total lesion count
Time Frame: change in lesion count over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, and 12 weeks.
change in lesion count over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, and 12 weeks.
Global Acne Grading System (GAGS)
Time Frame: Responses will be assessed at baseline, 4 weeks, and 12 weeks
Responses will be assessed at baseline, 4 weeks, and 12 weeks

Collaborators and Investigators

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

Sponsor

Ghurki Trust and Teaching Hospital

Investigators

  • Principal Investigator: Dr. Tahreem Alam Buzdar, Ghurki Trust Teaching Hospital
  • Study Director: Prof. Dr. Haroon Nabi, Lahore Medical and Dental College
  • Study Chair: Dr Aliza Hamadani, Lahore Medical and Dental College
  • Study Chair: Dr. Ayesha Asad Chattha, Ghurki Trust Teaching Hospital
  • Study Chair: Dr. Iram Kausar, Ghurki Trust Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 15, 2025

Primary Completion (Actual)

August 10, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10

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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