Efficacy of Oral Metformin vs Oral Doxycycline in Treating Acne Vulgaris

NCT07357337 | Completed Phase 4 DMC

• 1 other identifier: 10
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris on the Face; Acne Vulgaris

Keywords

acne vulgaris; metformin; doxycycline; oral; efficacy

Outcome Measures

Primary Outcomes (2)

• Total lesion count

  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)

  Responses will be assessed at baseline, 4 weeks, and 12 weeks

Study Arms (2)

Intervention Group: Group A

EXPERIMENTAL

Group A will receive oral tablet Metformin 500mg twice daily

Drug: oral metformin

Control Group: Group B

ACTIVE COMPARATOR

Group B will receive oral tablet Doxycycline 100mg once daily

Drug: Oral doxycycline

Interventions

oral metformin DRUG

Intervention group will recieve oral tablet Metformin 500mg twice daily

Intervention Group: Group A

Oral doxycycline DRUG

Group B will receive oral tablet Doxycycline 100mg once daily

Control Group: Group B

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ghurki Trust and Teaching Hospital: lead

Study Sites (1)

Ghurki Trust Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (5)

• Habeshian KA, Cohen BA. Current Issues in the Treatment of Acne Vulgaris. Pediatrics. 2020 May;145(Suppl 2):S225-S230. doi: 10.1542/peds.2019-2056L.

  PMID: 32358215 BACKGROUND

• Sadati MS, Yazdanpanah N, Shahriarirad R, Javaheri R, Parvizi MM. Efficacy of metformin vs. doxycycline in treating acne vulgaris: An assessor-blinded, add-on, randomized, controlled clinical trial. J Cosmet Dermatol. 2023 Oct;22(10):2816-2823. doi: 10.1111/jocd.15785. Epub 2023 May 2.

  PMID: 37128834 BACKGROUND

• Deng Y, Jiang S, Huang Y, Tan X, Huang Y, Chen L, Xu J, Xiong X, Zhou J, Xu Y. Metformin contributes to the therapeutic effects of acne vulgaris by modifying the gut microbiome. Dermatologic Therapy. 2023;2023(1):9336867.

  BACKGROUND

• Lee JK, Smith AD. Metformin as an adjunct therapy for the treatment of moderate to severe acne vulgaris. Dermatol Online J. 2017 Nov 15;23(11):13030/qt53m2q13s.

  PMID: 29447630 BACKGROUND

• Heng AHS, Chew FT. Systematic review of the epidemiology of acne vulgaris. Sci Rep. 2020 Apr 1;10(1):5754. doi: 10.1038/s41598-020-62715-3.

  PMID: 32238884 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Metformin; Doxycycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Dr. Tahreem Alam Buzdar

  Ghurki Trust Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Prof. Dr. Haroon Nabi

  Lahore Medical and Dental College

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 22, 2026
• Study Start: February 15, 2025
• Primary Completion: August 10, 2025
• Study Completion: October 1, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)