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CTRI Number  CTRI/2021/03/032173 [Registered on: 19/03/2021] Trial Registered Prospectively
Last Modified On: 02/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to evaluate the efficacy and safety of Dutasteride Topical Solutions (0.01%, 0.02% and 0.05%) with an active comparator Finpecia (finasteride Tablets 1mg) with Androgenetic Alopecia male subjects.  
Scientific Title of Study   A Phase II, Multicenter, Randomized, Double Blind, Double Dummy, Parallel, Controlled Clinical Study to evaluate the efficacy and safety of Dutasteride Topical Solutions (0.01%, 0.02% and 0.05%) of Shilpa Medicare Limited, India with an active comparator Finpecia (finasteride Tablets 1mg) of CIPLA LTD, India in Androgenetic Alopecia male subjects.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
P-677/19 Version Number: 02 Version Date: 22/01/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  O Suresh 
Designation  Project Manager 
Affiliation  QPS Bioserve India Private Limited 
Address  QPS Bioserve India Private Limited, Plot No.47, IDA, Balanagar.

Medchal
TELANGANA
500037
India 
Phone  04023070874  
Fax    
Email  suresh.oduru@qpsbioserve.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Sanjeeva Reddy 
Designation  General Manager 
Affiliation  QPS Bioserve India Private Limited 
Address  QPS Bioserve India Private Limited, Plot No.47, IDA, Balanagar.

Medchal
TELANGANA
500037
India 
Phone  040-23070874  
Fax    
Email  sanjeeva.reddy@qpsbioserve.com  
 
Details of Contact Person
Public Query  
Name  O Suresh 
Designation  Project Manager 
Affiliation  QPS Bioserve India Private Limited 
Address  QPS Bioserve India Private Limited, Plot No.47, IDA, Balanagar.

Medchal
TELANGANA
500037
India 
Phone  040-23070874  
Fax    
Email  suresh.oduru@qpsbioserve.com  
 
Source of Monetary or Material Support  
Shilpa Medicare Limited 
 
Primary Sponsor  
Name  Shilpa Medicare Limited 
Address  Plot No.29 A5 4th Phase, Averahalli INDL Area, Honenahalli Village, Somapura Hobli, Nelmangala Taluk, Bangalore Rural, Pin code: 562111 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jadhav Avinash Bajirao  7Orange Hospital  Pawana Nagar,Next to Jain School,Near Chapekar Chowk, Chinchwad,Pune
Pune
MAHARASHTRA 		 7741970087

dravinashbjadhav@gmail.com 
Dr Ghanshyam Mukund Vinod   Anand Multispeciality Hospital  B-Tower, Sundaravan Complex, Beside IOCL Petrol Pump, Near Gowra ITI, Vadodara-390016
Vadodara
GUJARAT 		 9824488194

gmvinod2004@yahoo.co.in 
Dr Narasimha Rao Netha  Gandhi Hospital  Department of Dermatology, 5th Floor, Gandhi Hospital, Musheerabad, Secunderabad-500003,
Hyderabad
TELANGANA 		 9390032196

gnrnetha@gmail.com 
Dr Dilip Gopal Jogaikar  Global Hospital & Research Institute  Survey Number 577/2,NearDattawadi Police Chowki,Off Sinhagad Road,Dattawadi,Pune
Pune
MAHARASHTRA 		 9822841980

drdjogaikar@gmail.com 
Dr Sowmya CS  Kempegowda Institute of Medical Sciences  Kempegowda Institute of Medical Sciences, Department of Dermatology, B Block, 2nd floor, Krishna Rajendra Road, Visveswarapuram, Bangalore, Karnataka-560004
Bangalore
KARNATAKA 		 9611116181

Sowmya.cs17@gmail.com 
Dr Venkata Krishna  Osmania General Hospital  Department of Dermatology, OP Building, 1st Floor, Osmania General Hospital, Afzalgunj, Hyderabad-500012,
Hyderabad
TELANGANA 		 9246345423

drvkananthula@gmail.com 
Dr Hari Kishan Kumar Y  Raja Rajeswari Medical College & Hospital  Raja Rajeswari Medical College & Hospital #202, Kambipura, Mysore Road, Bengaluru-560074
Bangalore
KARNATAKA 		 9902066568

drharikishankumar@gmail.com 
Dr Rashmi Badrinath Aderao  Skinovate Laser & Cosmetic Surgery Centre  Skinovate Laser & Cosmetic Surgery Centre, Office no: 302 & 303, Third Floor, Royal Avenue, Next to Hotel Shivar Garden, Pimple Saudagar, Pune-411017
Pune
MAHARASHTRA 		 9766410953

aderaorashmi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Anand Institutional Ethics Committee, Anand Multispecialty Hospital  Approved 
Institutional Ethics Committee, Gandhi Hospital  Submittted/Under Review 
Institutional Ethics Committee, Osmania Medical College  Approved 
Institutional Ethics Committee,Sai Sneh Hospital and Diagnostic Centre  Approved 
Institutional Ethics Committee,Sai Sneh Hospital and Diagnostic Centre  Approved 
KIMS Institutional Ethics Committee  Approved 
LPR Ethics Committee, Lifepoint Multispecialty Hospital  Approved 
Raja Rajeswari Medical College & Hospital Institution 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  Dutasteride Placebo Topical Solution  1 ml topical application once daily for study duration 
Intervention  Dutasteride Topical Solutions (0.01%)   1 ml (Each ml contains 0.1 mg of Dutasteride) topical application once daily for study duration  
Intervention  Dutasteride Topical Solutions (0.02%)   1 ml (Each ml contains 0.2 mg of Dutasteride) topical application once daily for study duration  
Intervention  Dutasteride Topical Solutions (0.05%)   1 ml (Each ml contains 0.5 mg of Dutasteride) topical application once daily for study duration  
Comparator Agent  Finasteride Placebo Tablet  Oral Finasteride Placebo Tablets 1 mg will be administered once daily for study duration 
Comparator Agent  Finpecia (finasterideTablets 1 mg)  Oral Finasteride Tablets 1 mg will be administered once daily for study duration 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1. Male Patients 20 to 60 years of age with male pattern hair loss (Androgenetic Alopecia) according to Norwood/Hamilton classification scale (III vertex, IV and V).
2. Subjects willing to provide written informed consent, indicating that they thoroughly understand the purpose of and procedures required for the study and are willing to participate in the study.
3. Patients with no experience of treatment with Dutasteride and Finasteride from past 12 months.
4. Patients willing to have a mark in the target area.
5. Patient’s willingness to maintain same hair length.
6. Either partner or patient must use an effective method of contraception for avoiding pregnancy for at least 2 weeks prior to the study drug administration, during the study and up to 60 days after the last dose.
 
 
ExclusionCriteria 
Details  1. Clinically relevant abnormal physical findings which could interfere with the aim of the study; in particular, skin damage such as skin abrasion, actinic keratosis or any abnormal findings in the scalp.
2. Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for atleast 3 months.
3. Suspicion of malignancy, including prostate cancer.
4. Patients who had hair transplant surgery or hair weaving.
5. Patient who had light or laser treatment on the scalp.
6. History or evidence of hair loss other than Androgenetic Alopecia (e.g. due to auto-immune, endocrine, mechanical or infectious process or secondary to a scalp dermatological disorder).
7. Patients with active seborrheic dermatitis.
8. History of varicocele.
9. Clinically relevant abnormal laboratory values indicative of physical illness.
10. Ascertained or presumptive hypersensitivity to the active formulations or any of the excipients.
11. Patient with significant clinical relevant endocrinal, cerebrovascular, skin, pulmonary, haematological, immunological and cardiovascular disease could lead to safety risk.
12. History of infertility or difficulty fathering children.
13. Patients who wish to conceive children during the study or whose sexual partner is pregnant.
14. Concurrent use of systemic corticosteroids, topical corticosteroids in the balding are studied, anabolic steroids, over-the-counter.
15. Use of the following drugs with anti-androgenic properties within 6 months of study entry: flutamide, Cypoterone acetate, estrogen, progesterone. Cimetidine, spironolactone, or ketoconazole.
16. Use of any of the following medications within 14 days prior to enrolment but not limited to:
• Strong inhibitors of CYP3A4
• Strong inducers of CYP3A4
• Drugs associated with QT prolongation
• Antihypertensive and other drugs known to cause hypotension
17. Patient with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
18. Patient had major surgery within 2 months prior to study entry, or who have not recovered from prior major surgery.
19. Patient with chronic Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
20. Patients with intake of alcohol greater than 2 drinks or equivalent per day.
21. Patient with willing to donate blood during the study and 90 days after completion of the study.
22. Participation in a drug research study within past 3 months.
23. Any condition/ abnormal baseline findings in the laboratory values that in the Investigators’ judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. expected changes in concomitant medication that may interfere in study

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
The change in the Target Area Hair Count (Density) within 1 cm2 at the vertex as assessed by macrophotography  From baseline to week 24 
 
Secondary Outcome  
Outcome  TimePoints 
The Change in the Target Area Hair Count (Density) within 1 cm2 at the vertex from baseline to end of week 12 as assessed by macrophotography  Baseline to end of week 12 
The Change in the Target Area Hair Count (Density) within 1 cm2 at the vertex from baseline/ week 12 to end of week 24 as assessed by macrophotography  From baseline/ week 12 to end of week 24 
The Change in the Target Area Hair Width (Thickness) in the vertex at week 12 and end of week 24 as assessed by macrophotography  Week 12 to end of and 24 
The Self-administered Male Hair Growth Questionnaire (MHGQ) at week 12 and end of week 24  Week 12 and end of week 24 
The investigator will assess change in hair growth from baseline to end of Week 12 and end of Week 24 in the Target Area Hair Count (Density) and Target Area Hair Width (Thickness) within 1 cm2 at the vertex, using a 7-point scale.   Baseline to end of Week 12 and end of Week 24 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/04/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The purpose of the study is to evaluate the efficacy and safety of Dutasteride Topical Solutions (0.01%, 0.02% and 0.05%) of Shilpa Medicare Limited, India with an active comparator Finpecia (finasteride Tablets 1mg) in Androgenetic Alopecia male subjects. 
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