| CTRI Number |
CTRI/2012/06/002732 [Registered on: 19/06/2012] 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 pilot study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Acne Scarring |
|
Scientific Title of Study
|
A Prospective, Multicentric, Open Label, Bio Interventional, Phase I, Phase II Pilot Study to Evaluate the Safety and Efficacy of Autologous Human Platelet Lysate (HPL) for Treatment of Acne Scarring |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KRPL/HPL-AS/11-12/004; Version 1.0 16th April 2012 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PH Maniar |
| Designation |
Dermatologist |
| Affiliation |
Radiance Cosmetology Clinique |
| Address |
ChandraPushpa Gr Floor Opp Laxmi Shopping Centre Behind Mayur Furniture
Near Ghatkopar Railway Station
Thane
MAHARASHTRA
400 086
India |
| Phone |
022-25134560 |
| Fax |
|
| Email |
radiance.clinic@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila Patil |
| Designation |
Consultant in Skin Diseases Leprosy and Cosmetology |
| Affiliation |
Dermocosmetic laser center hair and skin clinic |
| Address |
401 Classic Plaza Opp Rajawat Jewellers
Gokhale Road Naupada
Thane
MAHARASHTRA
400 602
India |
| Phone |
022-25405537 |
| Fax |
|
| Email |
drsharmilapatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushal Shah |
| Designation |
Head Clinical Research |
| Affiliation |
KASIAK RESEARCH PRIVATE LIMITED |
| Address |
1st Floor Building No1 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 |
1st Floor Building No.1 Dil Complex Near Tatwagyan Vidyapeeth Ghodbunder Road
Thane
MAHARASHTRA
400610
India |
| 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 Sharmila Patil |
Dermocosmetic laser center hair and skin clinic |
Room no. 401 Classic Plaza
Opp Rajawat Jewellers
Gokhale Road Naupada
Thane
MAHARASHTRA |
022-25405537
drsharmilapatil@gmail.com |
| Dr PH Maniar |
Radiance Cosmetology Clinique |
Gr Floor ChandraPushpa
Opp Laxmi Shopping Centre Behind Mayur Furniture
Near Ghatkopar Railway Station
Ghatkopar West
Mumbai
MAHARASHTRA |
022-25134560
radiance.clinic@hotmail.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 |
Acne Scarring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Human Platelet Lysate (HPL |
Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring |
| Intervention |
Autologous Human Platelet Lysate (HPL) |
Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
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. Subject willing to refrain from any other treatment of Acne Scarring during entire study duration.
3. Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study.
4. Subjects who are willing to give informed consent and adhere to the study protocol.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with active infection or active acne.
2. Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study.
3. Subjects with history of connective tissue disease.
4. Subjects with metabolic or hematopoietic disorders.
5. Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia.
6. Subjects who have received prior chemotherapy and radiotherapy
7. Subjects unwilling to or unable to comply with the study protocol.
8. 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
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Changes in the Global Acne scarring classification scores from screening to end of the study. |
End of study - 4 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Photographic Assessment
• Physician’s assessment scores for acne scarring.
• Patient’s assessment scores for acne scarring.
|
End of study - 4 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)
|
21/05/2012 |
| 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="7"
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 Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.
|