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CTRI Number  CTRI/2025/09/094187 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of oral spironolactone versus oral isotretinoin in treatment of acne in post-adolescent female patients. 
Scientific Title of Study   Comparative study of efficacy and safety of oral spironolactone versus oral isotretinoin in female patients with post-adolescent acne. 
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 Shivani Tripathi 
Designation  Junior Resident 
Affiliation  SBKS MI & RC 
Address  OPD 17, DEPARTMENT OF DERMATOLOGY SBKS Medical Institute and Research Center Pipariya Waghodia
OPD 17, DEPARTMENT OF DERMATOLOGY SBKS Medical Institute and Research Center Pipariya Waghodia
Vadodara
GUJARAT
391760
India 
Phone  9408593932  
Fax    
Email  shivanigt0910@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishan Ninama 
Designation  Professor 
Affiliation  SBKS MI & RC 
Address  OPD 17, DEPARTMENT OF DERMATOLOGY SBKS Medical Institute and Research Center Pipariya Waghodia
OPD 17, DEPARTMENT OF DERMATOLOGY SBKS Medical Institute and Research Center Pipariya Waghodia
Vadodara
GUJARAT
391760
India 
Phone  9099025287  
Fax    
Email  drkishanninama.dermatologist@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Tripathi 
Designation  Junior Resident 
Affiliation  SBKS MI & RC 
Address  OPD 17, DEPARTMENT OF DERMATOLOGY SBKS Medical Institute and Research Center Pipariya Waghodia
OPD 17, DEPARTMENT OF DERMATOLOGY SBKS Medical Institute and Research Center Pipariya Waghodia
Vadodara
GUJARAT
391760
India 
Phone  9408593932  
Fax    
Email  shivanigt0910@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Shivani Tripathi 
Address  OPD 17, DEPARTMENT OF DERMATOLOGY SBKS Medical Institute and Research Center Pipariya Waghodia Vadodara Gujarat India Pincode: 391760 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivani Tripathi  Dhiraj General Hospital  OPD 17, DEPARTMENT OF DERMATOLOGY SBKS Medical Institute and Research Center Pipariya Waghodia
Vadodara
GUJARAT 		 9408593932

shivanigt0910@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L700||Acne vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TABLET ISOTRETINOIN  Dose:0.5mg/kg Frequency: once a day Route of administration: Oral Total duration: 3 months 
Comparator Agent  TABLET SPIRONOLACTONE  Dose:100mg Frequency: once at night Route of administration: Oral Total duration: 3 months 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  (1)All women of 25-45 years of age with acne of grade 2 and 3 (as per Pillsbury scale). (2)Women with facial acne involving lower third of face (mandibular line, perioral region, and side of the neck). (3)Cases willing to give informed consent.

 
 
ExclusionCriteria 
Details  (1)Patients below the age of 25 years.
(2)Patients with grade 1 and 4 (as per Pillsbury scale)
(3)Patients with predominately truncal acne.
(4)Patients who have been on any topical or systemic treatment in last 1 month.
(5)Patient who have undergone procedures such as any chemical peel, acne scar surgery in last 15 days prior to enrollment.
(6)Pregnant and lactating women.
(7)Patients planning to conceive.
(8)Females on contraceptive or other medication that cause or worsen acne.
(9)Patients on corticosteroids/antiepileptics/AKT/ART/antipsychotics.
(10)Patient suffering from acne rosacea and other bacterial infections on face confounding the diagnosis of acne vulgaris.
(11)Patient suffering from Androgen-secreting adrenal or ovarian tumour, Cushing’s syndrome, Congenital adrenal hyperplasia.
(12)Patients who are immune-compromised or taking immunosuppressant.
(13)Patients undergoing chemotherapy.
(14)Patients with poor general health.




 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pillsbury grading scale, CADI, side effects  baseline, 2 week, 1 month, 2 month, 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
investigations: CBC, LFT, RFT, Hormonal profile, ultrasonography abdominal and pelvis, serum TSH, serum magnesium  baseline 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   17/09/2025 
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="0"
Months="3"
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  

The study is based on post-adolescent acne in women (acne occurring after age 25), a condition with significant physical and psychosocial impact. It outlines the disease’s epidemiology, causes, clinical features, and treatment options, emphasizing its multifactorial nature involving hormones, genetics, lifestyle, and environmental triggers.

The study’s aim is to compare the efficacy and safety of Oral Spironolactone (100 mg/day) versus Oral Isotretinoin (0.5 mg/kg/day) in female patients with post-adolescent acne. Patients will be assessed over 3 months using the Pillsbury acne grading scale for severity and the Cardiff Acne Disability Index (CADI) for quality of life.

The methodology includes a prospective, interventional comparative design with 40 female patients (25–45 years, acne grade 2–3), randomized into two groups:

  • Group A: Spironolactone + topical clindamycin

  • Group B: Isotretinoin + topical clindamycin

 Safety monitoring includes blood counts, liver function, lipid profile, and, in spironolactone patients, serum potassium and renal function.

Expected outcomes are to determine which drug is more effective and safer, thereby contributing to improved treatment strategies for post-adolescent acne.

 
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