| CTRI Number |
CTRI/2012/04/002549 [Registered on: 09/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
25/09/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comaprative study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Dark Circles |
|
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 Periorbital Hyperpigmentation (Dark Circles) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KRPL/HPL-FR/11-12/002A |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Farida Modi |
| Designation |
Consulting Dermatologist, Cosmetologist and Dermatosurgeon |
| Affiliation |
Derma Care |
| Address |
Derma Care
Skin Clinic and Cosmetic Centre
5 Unity House
Above SBI 2nd Floor
Opera House
Mumbai
MAHARASHTRA
400 004
India |
| Phone |
30020103 |
| Fax |
|
| Email |
faridasm@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Savardekar |
| Designation |
Consultant Dermatologist and Cosmetologist |
| Affiliation |
Shree Krishna Polyclinic |
| Address |
Shree Krishna Polyclinic
Krishna Building Gr Floor
JP Marg Worli
Near Summer park Hotel
Mumbai
MAHARASHTRA
400018
India |
| Phone |
24924455 |
| Fax |
|
| Email |
drpreeti25@rediffmail.com |
|
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 |
022-41173472 |
| Fax |
|
| Email |
kaushal.shah@kasiakresearch.com |
|
|
Source of Monetary or Material Support
|
|
|
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Farida Modi |
Derma Care Skin Clinic and Cosmetic Centre |
5 Unity House Above SBI
2nd Floor
Opera House
Mumbai
MAHARASHTRA |
30020103
faridasm@yahoo.com |
| Dr Preeti Savardekar |
Shree Krishna Polyclinic |
Krishna Building Gr Floor JP Marg Worli Near Summer park Hotel
Mumbai
MAHARASHTRA |
24924455
drpreeti25@rediffmail.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 |
Periorbital Hyperpigmentation (Dark Circles), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Human Platelet Lysate (HPL) |
Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2 |
| Comparator Agent |
Standard Therapy |
Topical Applications as directed by the investigator |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
2. Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
3. Subjects who are willing to give informed consent and adhere to the study protocol. |
|
| ExclusionCriteria |
| Details |
1. Subjects aged less than 18 and more than 55 years
2. Subjects with history of connective tissue disease.
3. Subjects with metabolic or hematopoietic disorders
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 30 days.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Physician’s assessment scores
• Patient’s assessment scores
|
End of Study - 3Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Photographic assessments |
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)
|
20/03/2012 |
| 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="6"
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 evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study. |