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CTRI Number  CTRI/2012/05/002627 [Registered on: 07/05/2012] Trial Registered Retrospectively
Last Modified On: 10/04/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   A study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Facial Wrinkles (Nasolabial Folds).  
Scientific Title of Study   A Prospective, Multicentric, Open Label, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KRPL/HPL-FR/11-12/002B  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rachita Dhurat 
Designation  Consultant Dermatologist 
Affiliation  Dr Rachitas Skin Trichology & Aesthetic Centre 
Address  Dr Rachita’s Skin, Trichology & Aesthetic Centre Shubham Flora, 204, Chembur Naka Opposite Chembur police station

Mumbai
MAHARASHTRA
400071
India 
Phone  9870390057  
Fax    
Email  rachitadhurat@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachita Dhurat 
Designation  Consultant Dermatologist 
Affiliation  Dr Rachitas Skin Trichology & Aesthetic Centre 
Address  Dr Rachita’s Skin, Trichology & Aesthetic Centre Shubham Flora, 204, Chembur Naka Opposite Chembur police station

Mumbai
MAHARASHTRA
400071
India 
Phone  9870390057  
Fax    
Email  rachitadhurat@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kaushal Shah 
Designation  Head Clinical Research 
Affiliation  KASIAK RESEARCH PRIVATE LIMITED 
Address  KASIAK RESEARCH PRIVATE LIMITED 1st Floor, Building No.1, Dil Complex, Near Tatwagyan Vidyapeeth, Ghodbunder Road

Thane
MAHARASHTRA
400610
India 
Phone  02241173472  
Fax    
Email  kaushal.shah@kasiakresearch.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  KASIAK RESEARCH PRIVATE LIMITED 
Address  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 Rachita Dhurat  Dr Rachitas Skin Trichology & Aesthetic Centre  204 Shubham Flora Chembur Naka Opposite Chembur police station
Mumbai
MAHARASHTRA 		 9870390057

rachitadhurat@yahoo.co.in 
Dr Geetanjali Shetty   Kapadia Multispeciality Hospital  Rambaugh, Kapadia Multispeciality Hospital M G Road Goregoan (West)
Mumbai
MAHARASHTRA 		 02228402506

geetanjalishetty@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  Facial Wrinkles (Nasolabial Folds),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autologous Human Platelet Lysate (HPL)  Subjects will receive single dose of 5mL of Autologous Human Platelet Lysate on Day 2 of enrollment in the study. 
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Subjects (male and female), aged 18 to 40 years (both inclusive).
2. Subjects willing to refrain from any other treatment for Nasolabial Folds.
3. Subjects who are willing to give informed consent and adhere to the study protocol. 
 
ExclusionCriteria 
Details  1. Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc
2. Subjects with history of Connective tissue disease
3. Subjects with autoimmune diseases
4. Subjects unwilling to or unable to comply with the study protocol.
5. Subjects taking concomitant therapy that might interfere with the study results in the investigator’s opinion or participating in another trial in the past 30days
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
• Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest
• Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading on full smile
• Global Aesthetic Improvement Scale (GAIS )
 		 End of Study - 3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
• Photographic Assessment
• Physician’s assessment scores
• Patient’s assessment scores
 		 End of Study - 3 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)   17/04/2012 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in  Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and   Global Aesthetic Improvement Scale (GAIS ) . The secondary endpoints are improvement in photographic assessment,   Physician’s assessment scores,  Patient’s assessment scores form enrollment to end of study. 
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