The efficacy and safety of low-dose spironolactone in the treatment of acne in transmen population: A randomized, double-blind, controlled trial study

The efficacy and safety of low-dose spironolactone in the treatment of acne in transgender men: A randomized, double-blind, controlled trial study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250417002

Enrollment

Registered

2025-04-17

Start date

2021-11-22

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Acne vulgaris in transmen acne vulgaris, transgender men, transmen

Interventions

Drug in tablet form,Similar appearance to the experimental drug

Experimental Drug,Placebo Comparator Drug

50 mg spironolactone,Placebo

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. transman 2. receiving gender-affirming hormonal therapy 3. having a serum testosterone level in the physiologic male range 4. having achieved the desired sexual characteristics 5. having mild to severe facial acne

Exclusion criteria

Exclusion criteria: 1. other facial skin condition preventing acne assessment 2. known allergy to spironolactone or topical agents used in the study 3. use of topical/oral treatment for acne within the past three months 4. current pregnancy or lactation 5. renal impairment 6. immunocompromised status 7. systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg

Design outcomes

Primary

Measure	Time frame
Investigator's Global assessment (IGA) Baseline, 4, 8, and 12 weeks Clinical evaluation by a blind evaluator	—

Secondary

Measure	Time frame
Total acne lesion count Baseline, 4, 8, and 12 weeks Clinical evaluation by a blind evaluator,Inflammatory acne lesion count Baseline, 4, 8, and 12 weeks Clinical evaluation by a blind evaluator,Non-inflammatory acne lesion count Baseline, 4, 8, and 12 weeks Clinical evaluation by a blind evaluator,Participant's Global Change Assessment (GCA) 4, 8, and 12 weeks Patient-reported change in acne severity from baseline in ordinal scale,Adverse events 4, 8, and 12 weeks Patient-reported outcome,Serum testosterone level 12 weeks Blood test,Serum potassium level 12 weeks Blood test,Serum creatinine level 12 weeks Blood test	—

Measure

Time frame

Total acne lesion count Baseline, 4, 8, and 12 weeks Clinical evaluation by a blind evaluator,Inflammatory acne lesion count Baseline, 4, 8, and 12 weeks Clinical evaluation by a blind evaluator,Non-inflammatory acne lesion count Baseline, 4, 8, and 12 weeks Clinical evaluation by a blind evaluator,Participant's Global Change Assessment (GCA) 4, 8, and 12 weeks Patient-reported change in acne severity from baseline in ordinal scale,Adverse events 4, 8, and 12 weeks Patient-reported outcome,Serum testosterone level 12 weeks Blood test,Serum potassium level 12 weeks Blood test,Serum creatinine level 12 weeks Blood test

—

Countries

Thailand

Contacts

Public ContactSuthinee Rutnin

Faculty of Medicine Ramathibodi Hospital, Mahidol University

suthinee.rutnin@gmail.com022011211

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026