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Single-center, randomized controlled study on the efficacy and safety of spironolactone combined with isotretinoin in the treatment of female adult acne

Single-center, randomized controlled study on the efficacy and safety of spironolactone combined with isotretinoin in the treatment of female adult acne

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042752
Enrollment
Unknown
Registered
2021-01-27
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-10

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

Conditions

acne

Interventions

experimental group:Isotretinoin 10mg qd orally + spironolactone 80mg/day orally for 24 weeks
control group:Isotretinoin 20mg qd orally for 24 weeks

Sponsors

The University of Hong Kong-Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) Female, aged >= 20 years; (2) Diagnosed as moderate to severe acne, IGA>=2; (3) No isotretinoin and anti-androgen therapy in the past 6 months, no oral antibiotics in the past 1 month, no new antibiotics, tretinoin, or benzoyl peroxide for topical therapy in the past 2 weeks; (4) Have clear contact information and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Other systemic diseases accompanied by acne (Addison's disease, Behcet's disease, etc.); (2) With rosacea; (3) Blood pregnancy test for pregnant and lactating women (+) Those who plan to become pregnant within 1 year and who refuse contraception; (4) Allergy to spironolactone isotretinoin; (5) Those who have not been able to use isotretinoin and spironolactone; (6) Orthostatic hypotension and hyperkalemia; (7) Application of potassium-sparing diuretic ACEI angiotensin 2 antagonist NSAID heparin digoxin eplerenone; (8) Inflammatory bowel disease, heart, liver and kidney basic diseases, glutathione/aspartate; aminotransferase/triglycerides/cholesterol exceeding the upper limit of normal 2 times; (9) People who are currently suffering from depression or have a history and family history of depression; (10) Participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Severity of illness;

Countries

China

Contacts

Public ContactZhang Zhenying

The University of Hong Kong-Shenzhen Hospital

zhangzy@hku-szh.org+86 18307556911

Outcome results

None listed

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