Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Spironolactone: Oral Spironolactone 100mg once daily administered for a duration of 12 weeks
Intervention2: Bicalutamide: Oral Bicalutamide 25 mg once daily administered for a duration
Sponsors
Bangalore Medical College and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Adult female patients aged more than 25 years with clinically diagnosed moderate to severe acne vulgaris as assessed by the Clinician Global Assessment score, willing to provide written informed consent and comply with follow-up visits
Exclusion criteria
Exclusion criteria: Pregnant or lactating women; patients aged less than 25 years; patients unwilling to provide informed consent or comply with follow-up; patients with renal impairment, hyperkalemia, liver dysfunction or known hypersensitivity to spironolactone or bicalutamide; patients who have received systemic antiandrogens, oral isotretinoin or systemic antibiotics for acne in the preceding 3 months; patients who have received topical acne therapy in the preceding 1 month; and patients planning pregnancy within the next 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Clinician Global Assessment (CGA) score for acne severityTimepoint: From baseline to week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions and changes in laboratory parameters( serum potassium , renal function tests and liver function tests ) during the study periodTimepoint: Baseline and every 4 weeks till 16 weeks | — |
Countries
India
Contacts
Public ContactDr Bhavya Kaliki
Bangalore Medical College and Research Institute
Outcome results
None listed