Acne vulgaris Acne vulgaris
Conditions
Interventions
Spironolactone 100mg once daily in the morning
Sponsors
Iwai Atsuko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with acne vulgaris, with at least 12 inflammatory lesions on the face 2) Patients aged between 18 and 59 years at the time of consent 3) Female patients 4) Patients who have not responded to treatment with at least one oral antibiotic for 4 weeks or more 5) Patients who provide written consent to participate in the clinical study.
Exclusion criteria
Exclusion criteria: 1) Patients taking Eplerenone, Esaxerenone 2) Patients taking Tacrolimus 3) Patient with anuria, acute or chronic renal failure 4) Patient with hyperkalaemia. 5) Patient with Addison's disease. 6) Patients with severe liver disease 7) Women who are pregnant, lactating, women who may be pregnant or intend to be pregnant. 8) Patients who are scheduled for local treatment such as peeling, comedone extraction, or laser during the study period. 9) Patients deemed inappropriate by the principal investigator or co-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in inflammatory lesion count at Week 12 on the face | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in inflammatory lesion count at Week 24 or at discontinuation on the face Changes in inflammatory lesion count at baseline, 12 weeks, and 24 weeks on the face Change from baseline in DLQI at Week 12 and 24 or at discontinuation Change in DLQI from baseline at Week 12 and 24 Change in IGA score from baseline at Week 12 and 24 or at discontinuation Changes in IGA score at baseline, 12 weeks, and 24 weeks Changes and rates of change in serum estradiol from baseline at Week 12 and 24 | — |
Contacts
Public ContactAtsuko Iwai
Nagoya City University East Medical Center
Outcome results
None listed