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Acne Vulgaris on the FacePhase 4NCT07357337

Efficacy of Oral Metformin vs Oral Doxycycline in Treating Acne Vulgaris

A Phase 4 study testing oral metformin and Oral doxycycline in people with Acne Vulgaris on the Face and Acne Vulgaris, run by Ghurki Trust and Teaching Hospital at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 40 years
Conditions the study is for
Acne Vulgaris on the Face, Acne Vulgaris
What is being tested?
oral metformin and Oral doxycycline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 sitePakistan
Study dates
15 Feb 2025to 1 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • •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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Ghurki Trust Teaching Hospital

    Lahore, Punjab Province

Other trials in Pakistan

About this study

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.

Read more

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.

Read the 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.

Being tested
oral metformin, Oral doxycycline
Keywords
acne vulgaris, metformin, doxycycline, oral, efficacy
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral metforminDrug

    Intervention group will recieve oral tablet Metformin 500mg twice daily

  • Oral doxycyclineDrug

    Group B will receive oral tablet Doxycycline 100mg once daily

Study groups in NCT07357337
Study groupRoleWhat they receive
Intervention Group: Group AExperimentalGroup A will receive oral tablet Metformin 500mg twice daily
Receives: Drug: oral metformin
Control Group: Group BActive comparatorGroup B will receive oral tablet Doxycycline 100mg once daily
Receives: Drug: Oral doxycycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total lesion count

    Measured: change in lesion count over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, and 12 weeks.

  2. Global Acne Grading System (GAGS)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start15 Feb 2025
  3. Primary completion10 Aug 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357337
Sponsor's protocol ID
10
Status last verified
Jan 2026
First submitted
6 Jan 2026
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32358215

  • 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.

    PubMed 37128834

  • 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.

  • 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.

    PubMed 29447630

  • 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.

    PubMed 32238884

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing oral metformin and Oral doxycycline in people with Acne Vulgaris on the Face and Acne Vulgaris, run by Ghurki Trust and Teaching Hospital at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357337, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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