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CTRI Number  CTRI/2012/04/002614 [Registered on: 27/04/2012] Trial Registered Retrospectively
Last Modified On: 10/04/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL)for Treatment of Androgenetic Alopecia (AGA) 
Scientific Title of Study   A Prospective, Multicentric, Open Label, Randomized, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment Of Androgenetic Alopecia (AGA) 
Secondary IDs if Any  
Secondary ID  Identifier 
KRPL/HPL-AGA/11-12/001A   Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajendarsingh Rajput 
Designation  Hair Restorative Surgeon 
Affiliation   
Address  Dr. Rajesh Rajput Hair Restore 201 A Wing, Gasper Enclave Pali Market Bandra West

Mumbai
MAHARASHTRA
400050
India 
Phone  022-26415298  
Fax    
Email  drrajeshrajput@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Sattur 
Designation  Hair Restorative Surgeon 
Affiliation   
Address  Hair Revive, 103 Options Commercial Centre Dr Vasant Avasane Marg, Near Milan Subway, Santacruz (West

Mumbai
MAHARASHTRA
400054
India 
Phone  022-26136575  
Fax    
Email  drsattur@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kaushal Shah 
Designation  Head Clinical Research 
Affiliation   
Address  Kasiak Research Pvt Ltd 1st Floor Building No.1, Dil Complex, Near Tatwagyan Vidyapeeth, Ghodbunder Road,

Thane
MAHARASHTRA
400610
India 
Phone  022-41173472  
Fax    
Email  kaushal.shah@kasiakresearch.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Kasiak Research Pvt Ltd 
Address  KASIAK RESEARCH PRIVATE LIMITED 1st Floor, Building No.1, Dil Complex, Near Tatwagyan Vidyapeeth, Ghodbunder Road, Thane (West) - 400610  
Type of Sponsor  Other [Biotechnology company ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajendarsingh Rajput  Dr. Rajesh Rajput Hair Restore  201 A Wing Gasper Enclave Pali Market Bandra (West) Mumbai 400050
Mumbai
MAHARASHTRA 
022-26415298

drrajeshrajput@gmail.com 
Dr Sandeep Sattur  Hair Revive  103 Options Commercial Centre Dr Vasant Avasane Marg, Near Milan Subway, Santacruz (West), Mumbai 400054
Mumbai
MAHARASHTRA 
022-26136575

drsattur@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Clinical Ethics Forum (CEF); Mumbai  Approved 
Clinical Ethics Forum; Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Androgenetic Alopecia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autologous Human Platelet Lysate (HPL)  3 doses of HPL will be injected intradermally at an interval of one month each. 
Comparator Agent  Standard Therapy  Topical treatments as directed by the Physician 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1. Male subjects, aged between 18 to 50 years (both inclusive) and in general good health
2. Subjects willing to refrain from other AGA treatments during the entire study duration
3. Subjects who are willing to give informed consent and adhere to the study protocol.
 
 
ExclusionCriteria 
Details  1. Subjects aged <18 or > 50 years
2. Subjects with dermatological disorder of scalp that might interfere with study evaluation
3. Subjects on Anti-coagulant therapy
4. Subjects with clinically significant medical or psychiatric disease as determined by the investigator.
5. Subjects with dermatological disorder of scalp that might interfere with study evaluation
6. Subjects unwilling to or unable to comply with the study protocol. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in Calibre & Density of Hair as assessed by Folliscope
2. Photographic assessment from randomization to end of study
 
End of Study- 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Physician’s assessment score
2. Patient’s self assessment score
 
End of Study- 6 Months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   25/01/2012 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary  

This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Caliber & Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.

 
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