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CTRI Number  CTRI/2024/05/067989 [Registered on: 28/05/2024] Trial Registered Prospectively
Last Modified On: 17/02/2025
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 study to check efficacy and safety of combination of topical formulations in the treatment of 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/2023/007/II, Version 2.0 Dated 02-Jan-2024  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  Deputy General Manager- Clinical Development 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri (East)

Mumbai
MAHARASHTRA
400099
India 
Phone  2240189999  
Fax    
Email  Devang.Parikh@glenmarkpharma.com  
 
Details of Contact Person
Public Query  
Name  Amol Pendse 
Designation  Sr. General Manager-Clinical Research Operations 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Research Centre, Plot No. A-607, T.T.C. Industrial Area, MIDC, Mahape, Navi Mumbai

Mumbai
MAHARASHTRA
400709
India 
Phone  2267720000  
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 State: Maharashtra 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd, Plot No E37 TO 39, D-Road, MIDC Satpur, Tal Mahanagar Palika 1 tro 61, Z-1, Dist Nashik 422007 State: Maharashtra  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
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 Road, Nashik – 422101
Nashik
MAHARASHTRA 		 9373901829

suneel.vartak@gmail.com 
Dr Rajiv Sharad Joshi  Clinical Aesthetics and Investigative Management Services (C.L.A.I.M.S.) Pvt. Ltd.  27 MIDC Commercial Premises, 5th Floor, 17th Road, MIDC, Andheri East, Mumbai – 400093
Mumbai (Suburban)
MAHARASHTRA 		 9322276418

rsjdrs@gmail.com 
Dr Rajkumar Kothiwala  Jawahar Lal Nehru Medical College  Jawaharlal Nehru Medical College, Kala Bagh, Ajmer - 305001, Rajasthan
Ajmer
RAJASTHAN 		 9414118811

doctor.rajkumark@gmail.com 
Dr Sonal Shendkar Mahadev  Lifepoint Multispecialty Hospital  145/1, Mumbai-Bangalore Highway, Near Hotel Sayaji, Wakad, Pune-411057
Pune
MAHARASHTRA 		 9697546546

shendkar.sonal82@gmail.com 
Dr Nipul Vallabhdas Vara  Sir Sayajirao General Hospital  2nd Floor, New Emergency Building, Jail Road, Indira Avenue, Sayajigunj, Vadodara – 390001
Vadodara
GUJARAT 		 9426074084

nipulvara@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Claims Independent Ethics Committee  Approved 
Institutional Ethics Committee for Human Research, Medical College and SSG Hospial Baroda  Approved 
Institutional Ethics Committee, Assured Care Plus Hospital  Approved 
Institutional Ethics Committee, Jawaharlal Nehru Medical College  Approved 
LPR (Lifepoint Research) Ethics Committee  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 5% Solution  Dosage Form: Solution for topical application Dose: 1 mL (5 sprays) Dosage Frequency: Twice daily Mode of Administration: Local topical application  
Intervention  Test formulation A (Dutasteride and Minoxidil 0.05%/5%)   Dosage Form: Solution for topical application Dose: 1 mL (5 sprays) Dosage Frequency: Once daily Mode of Administration: Local topical application  
Intervention  Test formulation B (Dutasteride and Latanoprost 0.05%/0.03% w/v)  Dosage Form: Solution for topical application Dose: 1 mL (5 sprays) Dosage Frequency: Once daily Mode of Administration: Local topical application  
Comparator Agent  Vehicle Solution (Placebo/Vehicle)  Dosage Form: Solution for topical application Dose: 1 mL (5 sprays) 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.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.
2. Subject is willing to undergo study procedures for hair growth assessment including hair trimming and hair dye.
3. 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.
4. 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. (Daily styling non-medicated products [e.g., hair oil, gel, styling spray, etc.] will be allowed on non-study visit days).
5. 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 study drug, examination or outcome, such as alopecia areata, other non-AGA forms of alopecia, fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
2. 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 (e.g., uncontrolled thyroid disease, uncontrolled asthma, hypogonadism, human immunodeficiency virus [HIV] infection, connective tissue disease, inflammatory bowel disease, malignancy or suspicion of malignancy including prostate cancer, etc.).
3. 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).
4. 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 study drugs or put the subject at risk.
5. Subject has a current or recent history (within 3 months) of significant dietary changes or a history of eating disorder.
6. 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. 
 
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)  From baseline to End of Treatment (Week 24)
 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in non-vellus TAHC at Week 8 and 16  From Baseline to Week 8 and 16 
Change from baseline in vellus TAHC at Week 8, 16, and 24.  From Baseline to Week 8, 16, and 24 
Change from baseline in total TAHC at Week 8, 16, and 24.  From Baseline to Week 8, 16, and 24 
Change from baseline in target area hair thickness (diameter) at Week 8, 16, and 24.  From Baseline to Week 8, 16, and 24 
Proportion of subjects with more than and equal to +1 hair growth as assessed by Subject Self-Assessment (SSA) at Week 8, 16, and 24.  At Week 8, 16, and 24 
Proportion of subjects with more than and equal to +1 hair growth as assessed by Investigator Global Assessment (IGA) at Week 8, 16, and 24.  At Week 8, 16, and 24. 
Adverse events (from start to end of study)  From Start to End of study 
 
Target Sample Size   Total Sample Size="236"
Sample Size from India="236" 
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)   10/06/2024 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 [Test formulation A (Dutasteride and Minoxidil 0.05%/5%); Test formulation B (Dutasteride and Latanoprost 0.05%/0.03% w/v); Minoxidil 5% Solution; Vehicle Solution] 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, will be recorded and assessed for severity, seriousness and causality. 
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