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CTRI Number  CTRI/2026/04/107994 [Registered on: 09/04/2026] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the efficacy and safety of fixed dose combination of topical formulations in the treatment of androgenetic alopecia in men. 
Scientific Title of Study   A Phase 2, Randomized, Double-blind, Active- and Placebo- controlled, Parallel-group, Multicenter Trial to Evaluate Efficacy and Safety of New Topical Formulations in the Treatment of Androgenetic Alopecia in Men. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GPL/CT/2024/001/II, Version 2.0, Dated 26-Jul-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Devang Parikh 
Designation  DGM- Clinical Development 
Affiliation  Glenmark Pharmaceuticals Limited  
Address  Glenmark House, B D Sawant Marg Chakala, Andheri (East)

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  912240189999  
Fax    
Email  Devang.Parikh@glenmarkpharma.com  
 
Details of Contact Person
Public Query  
Name  Amol Pendse 
Designation  Sr. GM-Clinical Research Operations 
Affiliation  Glenmark Pharmaceuticals Limited  
Address  Glenmark Research Centre, Plot No. A-607, T.T.C. Industrial Area, MIDC, Mahape, Navi Mumbai

Thane
MAHARASHTRA
400709
India 
Phone  912267720000  
Fax    
Email  Amol.Pendse@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd, Glenmark House, B.D. Sawant Marg, Chakala, Andheri East, Mumbai, 400099 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd. 
Address  Glenmark House, B.D. Sawant Marg, Chakala, Andheri East, Mumbai State: Maharashtra PIN Code: 400099 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Glenmark Pharmaceuticals Ltd  B2, Mhalaxmi Chambers 22, Bhulabai Deasai Road, Mumbai-400026 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suneel Chandrakant Vartak  Assured Care Plus Hospital  4th and 5th Floor, Star Plus Complex, Lam Road, Near Muktidham Temple, Opp. NMC Divisional Office, Nashik – 422101
Nashik
MAHARASHTRA 		 9373901829

suneel.vartak@gmail.com 
Dr Saswati Halder  Calcutta School of Tropical Medicine  Professor and Head Department Dermatology ,calcutta School of Tropical Medicine 108 ,Chittaranjan Avenue Kolkata-700073
Kolkata
WEST BENGAL 		 7980669705

saswatihalder32@gmail.com 
Dr Nisha Parikh  CIMETs Inamdar Multispeciality Hospital  S. No. 15, behind KPCT mall, Fatima Nagar, Wanawadi, Pune 411040
Pune
MAHARASHTRA 		 9673834553

drnishaparikh@gmail.com 
Dr Sowmya CS  Kempegowda Instittute of medical sciences(KIMS)  Department Dermatology, Krishna Rajendra(KR) road, Visweshawar(VV) puram, Bangalore-560004
Bangalore
KARNATAKA 		 9611116181

kimssowmya@gmail.com 
Dr Nipul Vara  Sir Sayajirao General Hospital  6th Floor, New Emergency Building, Jail Road, Indira Avenue, Sayajigunj, Vadodara – 390001
Vadodara
GUJARAT 		 9426074084

nipulvara@gmail.com 
Dr Eswari L  Victoria Hospital  Department Dermatology,New OPD, Victoria Hospital,Bangalore medical college and research institute, KR road, Fort, Bangalore-560002
Bangalore
KARNATAKA 		 9845935375

eshwaril@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Clinical Research ethics Committee, calcutta School of Tropical Medicine  Submittted/Under Review 
Ethics Committee Inamdar Multispeciality Hospital  Submittted/Under Review 
Ethics Committee of BMCRI, Bangalore medical college and research institute  Submittted/Under Review 
Institutional Ethics Committee Assured Care Plus Hospital  Approved 
Institutional Ethics Committee for Human Research, Medical College - Baroda  Approved 
KIIMS Institutional ethics committee, Kempegowda Instittute of medical sciences(KIMS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L649||Androgenic alopecia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Minoxidil Solution  Dosage Form: Solution for topical application Dose: 1 g Dosage Frequency: Twice daily Mode of Administration: Local topical application  
Comparator Agent  Placebo of Topical solution  Dosage Form: Solution for topical application Dose: 1 g Dosage Frequency: Twice daily Mode of Administration: Local topical application  
Intervention  Treatment 1 (Clascoterone and Minoxidil Topical Solution)  Dosage Form: Solution for topical application Dose: 1 g Dosage Frequency: Twice daily Mode of Administration: Local topical application  
Intervention  Treatment 2 (Clascoterone and Latanoprost Topical Solution)  Dosage Form: Solution for topical application Dose: 1 g Dosage Frequency: Twice daily Mode of Administration: Local topical application 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  1. Subject is willing to provide written informed consent.
2. Male subject of 20 to 55 (both inclusive) years of age with a clinical diagnosis of AGA and Norwood-Hamilton pattern of baldness III vertex, IV or V.
3. Subject is willing to undergo study procedures for hair growth assessment including hair trimming and hair dye.
4. Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study and only use suggested hair shampoo, conditioner, and hair style products during the study.
5. Subject is agreeing to refrain from hair weaving, new hair colorants or dyes and non- study hair growth products (topical or systemic) or devices during the study.
6. Subject is surgically sterile OR is willing to use a highly effective form of contraception. 
 
ExclusionCriteria 
Details  1. Subject has current or recent history (within 3 months) of any dermatological disorders of the scalp other than AGA which, in the Investigator’s opinion, may interfere with the application of the investigational product, examination or outcome, such as other non- AGA forms of alopecia, fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, significant sunburn to the scalp, scars, or scalp atrophy.
2. Subject has current or history of clinical diagnosis of alopecia areata, scalp scars and atrophy.
3. Subject has history of any medical condition which, in the opinion of the Investigator, could influence the hair growth, interfere with the evaluation of the study treatment for safety and efficacy or requires the use of interfering topical or systemic therapy.
4. Subject has known hypersensitivity, previous allergic reaction or contraindication to any of the active or inactive component(s) of the study treatment or the products used in procedures (e.g., hair dye).
5. Subject with clinically significant finding(s) from medical history including suspicion of infertility, physical examination, laboratory tests, ECG, or vital signs that, in the opinion of the Investigator, could interfere with the evaluation of the investigational products or put the subject at risk.
6. Subject has a current or recent history (within 3 months) of significant dietary changes or a history of eating disorder.
7. Subject with history of platelet rich plasma (PRP) procedure on the scalp within 6 months of randomization.
8. Subject with history of hair transplants, hair weaves or non-breathable wigs.
9. Current use or history of using any of the prohibited topical or systemic treatment(s) or procedure(s) on the scalp which, in the opinion of the Investigator, could influence the hair growth and interfere with the evaluation of the study treatment.
10. Employee of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
11. Subject with history of substance/drugs/alcohol abuse or dependence that in the opinion of the Investigator is considered to interfere with the subject’s participation in the study.
12. Subject with history of HIV, hepatitis B, and hepatitis C infection.
13. Subject is not agreeing to restrain from blood donation during the study.
14. Subject with history of investigational drug/device use or participation in an interventional trial within 3 months or 5 half-lives of the product (whichever is longer) prior to randomization. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in non-vellus target area hair count (TAHC) at the end of treatment (Week 24)  At Week 24 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in non-vellus TAHC at Week 8 & 16.  At Week 8 & 16 
Change from baseline in vellus TAHC at Week 8, 16, & 24.  At Week 8, 16 & 24 
Change from baseline in total TAHC at Week 8, 16, & 24.  At Week 8, 16 & 24 
Change from baseline in target area hair thickness (diameter) at Week 8, 16, & 24.  At Week 8, 16 & 24 
Proportion of subjects with more than & equal to +1 rating of hair growth as assessed by Subject Self-Assessment (SSA) at Week 8, 16, & 24.  At Week 8, 16 & 24 
Proportion of subjects with more than & equal to +1 rating of hair growth as assessed by Investigator Global Assessment (IGA) at Week 8, 16, & 24.  At Week 8, 16 & 24 
Adverse events (Week 0 to end of study).  Throughout the study period 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 2 
Date of First Enrollment (India)   25/04/2026 
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="6"
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 randomized, double-blind, active- and placebo-controlled, parallel group, multicentre study comparing the efficacy and safety of the topical Test formulations in the treatment of AGA in men. The study will be conducted at multiple sites in India. The anticipated maximum duration of study participation for each subject is up to 27 weeks. This consists of a screening period of up to 2 weeks, treatment period of up to 24 weeks and post-treatment 1-week follow-up. The primary outcome measure will be change from baseline in non-vellus TAHC at the end of treatment (Week 24). Any adverse event (AE), either clinical/laboratory along with application site reaction, will be recorded and assessed for severity, seriousness and causality. 
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