A multicentre, randomized, parallel-controlled clinical trial of oral metformin in the adjuvant treatment of acne vulgaris and the effect on gut microbiota in patients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200058107

Enrollment

Unknown

Registered

2022-03-29

Start date

2019-01-01

Completion date

Unknown

Last updated

2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Interventions

Treatment group for mild acne vulgaris:Oral metformin + topical benzoyl peroxide, adapalin

Control group for mild acne vulgaris:The placebo + topical benzoyl peroxide, adapalin

Treatment group for severe acne vulgaris:Oral administration of isotretinoic acid, metformin + topical benzoyl peroxide, adapalin

Control group for severe acne vulagris:Oral isotretinoic acid, placebo + topical benzoyl peroxide, adapalin

Healthy control:None

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for acne; 2. Age>13 years,<25 years; 3. Body mass index (BMI) 18-25; 4. Sign the informed consent form and agree to participate in the experiment; 5. The patient and the control group did not systematically apply any antibiotics, glucocorticoids, immunosuppressants, traditional Chinese medicine, etc. within 6 months; 6. Acne patients did not use oral isotretinoin for 6 months.

Exclusion criteria

Exclusion criteria: 1. Other skin diseases: contact dermatitis, atopic dermatitis, eczema, psoriasis, ichthyosis, skin fungal infection, etc; 2. Immune deficiency or other immune diseases; 3. Metabolic diseases: obesity, hypertension, diabetes, hyperlipidemia, fatty liver disease, etc; 4. Tumor and other serious medical diseases; 5. Smokers and alcoholics; 6. Pregnant and lactating women; 7. Patients who have undergone resection of colon, ileum, gallbladder, appendix, etc; 8. Systemic application of antibiotics, hormones and immunosuppressants within 6 months before specimen collection; 9. Those who refuse to sign the informed consent form.

Design outcomes

Primary

Measure	Time frame
Severity of Acne vulgaris;gut microbiota;gut metabolites;	—

Secondary

Measure	Time frame
hormones;Insulin resistance;The biochemical indicators;	—

Countries

China

Contacts

Public ContactYongqiong Deng

The Affiliated Hospital of Southwest Medical University

dengyongqiong1@126.com+86 13679670608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026