| CTRI Number |
CTRI/2026/01/102574 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of oral spironolactone and oral bicalutamide for the treatment of adult female acne |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy and safety of oral spironolactone versus oral bicalutamide for the treatment of adult female acne-a randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavya Kaliki |
| Designation |
Postgraduate resident , Department of Dermatology, BMCRI,Bangalore |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Dermatology,
Bangalore Medical College and Research Institute,
K.R. Road,
Fort,
Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
7348850799 |
| Fax |
|
| Email |
bhavyakaliki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa K |
| Designation |
Head of Department , Department of Dermatology, BMCRI,Bangalore |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Dermatology,
Bangalore Medical College and Research Institute,
K.R. Road,
Fort,
Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9886553646 |
| Fax |
|
| Email |
shilpakvinod1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavya Kaliki |
| Designation |
Postgraduate resident , Department of Dermatology, BMCRI,Bangalore |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Dermatology,
Bangalore Medical College and Research Institute,
K.R. Road,
Fort,
Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
7348850799 |
| Fax |
|
| Email |
bhavyakaliki@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute,
Fort,
Kalasipalya,
Bangalore,
Karnataka,
India-560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Bangalore Medical College and Research Institute,
Fort, Kalasipalya,
Bangalore,
Karnataka,
India-560002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavya Kaliki |
Bangalore Medical College and Research Institute |
Department of Dermatology
Bangalore Medical College and Research Institute,
K.R. Road,
Fort,
Bangalore
Bangalore
KARNATAKA |
7348850799
bhavyakaliki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bicalutamide |
Oral Bicalutamide 25 mg once daily administered for a duration of 12 weeks |
| Comparator Agent |
Spironolactone |
Oral Spironolactone 100mg once daily administered for a duration of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Clinician Global Assessment (CGA) score for acne severity |
From baseline to week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse drug reactions and changes in laboratory parameters( serum potassium , renal function tests and liver function tests ) during the study period |
Baseline and every 4 weeks till 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, open-label, randomized controlled trial conducted to compare the efficacy and safety of oral spironolactone and oral bicalutamide in adult female patients with moderate to severe acne. A total of 60 eligible participants will be randomized in a 1:1 ratio to receive either oral spironolactone 100 mg once daily or oral bicalutamide 25 mg once daily for 12 weeks. Patients will be followed up at regular intervals up to 16 weeks. Efficacy will be assessed using the Clinician Global Assessment (CGA) score for acne, and safety will be evaluated by monitoring adverse drug reactions and relevant laboratory parameters. The study aims to generate evidence to guide optimal hormonal therapy for adult female acne. |