| 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) |
| Trial Acronym |
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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, 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.
|