| Registry | NCT07357337 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 68 (Actual) |
| Sponsor | Ghurki Trust and Teaching Hospital (Other) |
| Conditions | Acne Vulgaris on the Face, Acne Vulgaris |
| Interventions | oral metformin, Oral doxycycline (Drug) |
| Dates | start 2025-02-15, primary completion 2025-08-10, completion 2025-10-01, first posted 2026-01-22, last updated 2026-01-22 |
| Locations | 1 site in Pakistan |
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All trials for Acne Vulgaris on the Face All trials for Acne Vulgaris All trials of oral metformin All trials of Oral doxycycline
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Group: Group A | Experimental | Drug: oral metformin | Group A will receive oral tablet Metformin 500mg twice daily |
| Control Group: Group B | Active comparator | Drug: Oral doxycycline | Group B will receive oral tablet Doxycycline 100mg once daily |
Sex: All, ages: 12 Years to 40 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Ghurki Trust Teaching Hospital | Lahore, Punjab Province | Pakistan |