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To compare the use and side effects of tablet spironolactone and oral combined contraceptive pills in adult female acne.

A comparative study to evaluate the efficacy and safety of oral spironolatone versus oral low dose combined ethinylestradiol plus levonorgestrol contraceptive pills for the treatment of adult female acne. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083068
Enrollment
86
Registered
2025-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: Spironolactone for adult female acne: oral spironolactone tablets 100 mg OD given to patients with adult female acne for 3 months. Intervention2: Oral combined contraceptive pills are g

Sponsors

Dr Chandan Srinivasa K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient of female gender age more than 25 years 2. Patients willing to give informed consent 3. Patients willing for follow up. 4. All clinically diagnosed cases of moderate to severe adult female acne.

Exclusion criteria

Exclusion criteria: 1. Patients not willing to give informed consent. 2. Patients less than 25 years of age. 3. Patients with contraindications to Oral contraceptive pills . 4. Patients with contraindications to oral spironolactone 5. Patients on injectible hormones 6 months before enrolment 6. Patients on implantable and oral hormones in the last 3 months before enrolment to study 7. Patients on isotretinoin 3 months before enrolment 8. Patients on systemic antibiotics 3 month before enrolment 9. Patients on topical acne treatments 1 month before enrolment 10. Patients planning to conceive in the next 6 months

Design outcomes

Primary

MeasureTime frame
Decrease in Clinician global assessment score (CGA) over 6 months to calculate efficacyTimepoint: Clinician global assessment score (CGA) is recorded and serial photographs are taken in every monthly visit over 6 months

Secondary

MeasureTime frame
SafetyTimepoint: Safety is assessed by looking into the side effects seen to oral spironolactone or oral combined ethinylestradiol and levonorgesterol over 6 months

Countries

India

Contacts

Public ContactDr Shilpa K

Bangalore medical college and research institute

shilpakvinod1980@gmail.com9886553646

Outcome results

None listed

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