CTRI Number |
CTRI/2023/08/056292 [Registered on: 08/08/2023] Trial Registered Prospectively |
Last Modified On: |
08/08/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Platelet derived growth factors ] |
Study Design |
Single Arm Study |
Public Title of Study
|
Injectable platelet rich fibrin in androgenetic alopecia ( Patterened baldness) |
Scientific Title of Study
|
To study the efficacy and safety of injectable platelet rich fibrin in androgenetic alopecia- An interventional study |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sahana N C |
Designation |
Fellowship student |
Affiliation |
Bangalore medical college and research institute |
Address |
Department of Dermatology
Victoria hospital, BMCRI
New tharagupet road
Bangalore Bangalore medical college and research institute
New tharagupet road
Bangalore Bangalore KARNATAKA 560002 India |
Phone |
9449998099 |
Fax |
|
Email |
bhatt.sahana5@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sahana N C |
Designation |
Fellowship Student |
Affiliation |
Bangalore medical college and research institute |
Address |
Department of Dermatology
Victoria hospital, BMCRI
New tharagupet road
Bangalore Bangalore medical college and research institute
New tharagupet road
Bangalore Bangalore KARNATAKA 560002 India |
Phone |
9449998099 |
Fax |
|
Email |
bhatt.sahana5@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sahana N C |
Designation |
Fellowship Student |
Affiliation |
Bangalore medical college and research institute |
Address |
Department of Dermatology
Victoria hospital, BMCRI
New tharagupet road
Bangalore Bangalore medical college and research institute
New tharagupet road
Bangalore Bangalore KARNATAKA 560002 India |
Phone |
9449998099 |
Fax |
|
Email |
bhatt.sahana5@gmail.com |
|
Source of Monetary or Material Support
|
Bangalore medical college and research institute
Department of Dermatology |
|
Primary Sponsor
|
Name |
Dr Sahana N C |
Address |
Department of dermatology
Bangalore medical college and research institute |
Type of Sponsor |
Other [Self ] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Sahana N C |
Victoria hospital, Bangalore medical college and research institute |
Room no 53, Trichology OPD, 1st floor, B block, Department of Dermatology Bangalore KARNATAKA |
9449998099
bhatt.sahana5@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Bangalore medical college and research institute |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Injection of injectable Platelet rich firbrin |
Injection of platelet rich fibrin into the scalp prepared from patients own blood |
Comparator Agent |
Not applicable |
Not applicable |
Intervention |
Oral medication and topical medication |
Minoxidil 5% lotion
Tab Finasteride 1mg |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patients willing to give informed consent
2. Patients of either gender aged 18 to 60 years.
3. Androgenetic Alopecia in males with Norwood-Hamilton grade 2-6 and females beyond grade 1 according to Ludwig’s scale.
4. Patients willing for follow up. |
|
ExclusionCriteria |
Details |
1. patients with Alopecia other than Androgenetic Alopecia
2. Patients with active infection at the local site
3. Patients with keloidal tendency
4. Patients with blood coagulopathies and platelets count below 1,50,000cell/mm3
5. Pregnant and lactating mothers.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Trichoscopic improvement/ maintenance in the hair density / diameter |
4 sessions at 2 weekly intervals
Final assessment at the end of 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improvements in visual analogue scale
Improvements in global photography |
At the end of 3 months |
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
16/08/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Androgenetic alopecia (AGA), also known as male or female pattern hair loss, is one of the most common chronic progressive hair loss. It’s an androgen dependent and genetically mediated disorder affecting 50% of the population. In AGA there is progressive involvement of frontal, temporal, midscalp and vertex region in males and incomplete involvement of these regions with preservance of frontal hairline in females. AGA is a significant stressor and a major cause of low self-esteem and depression. The utility of platelet-rich plasma (PRP) has spanned various fields of dermatology. Injectable-PRF is considered the third generation of platelet concentrates possessing a higher and longer release of a variety of growth factors, cytokines and a delicate three-dimensional scaffold structure. It’s developed by modifying spin centrifugation forces based on low speed centrifugation concept (LSCC).5 PRF induces differentiation of stem cells, prolongs survival of dermal papillary cells, prolongs the anagen phase of the hair cycle, increases perifollicular vascular plexus by multiple mechanisms through various growth factors. i-PRF is a simple, less time consuming, cost effective method which need further evaluation in androgenetic alopecia. METHODOLOGY After obtaining approval and clearance from the institutional ethics committee, the patients with androgenetic alopecia fulfilling the inclusion criteria and willing to give informed consent will be enrolled in the study. Details regarding the symptoms, duration, site, family history, precipitating factor and previous treatments if any will be recorded. Global photography of scalp will be taken before and after the treatment and at the end of follow- up period. Trichoscopy will be done in an area of 1 cm2 marked. A metric tape measure graduated in centimeters will be used to mark the square centimeter and the longitudinal distance from the corresponding end of the eyebrow or nasal root. The image of the area will then be amplified using a trichoscope and photographs will be taken before each injection.
10-40 ml of blood will be collected and filled in plain vacutainer tubes (without an anti-coagulant) of 5 ml each and will be centrifuged immediately at 700 rotations per minute for 3 minutes using a REMI-R8C centrifuge machine. The i-PRF (yellow-reddish liquid) formed at the upper part of the tube will be collected using 31G insulin syringes and injected at a distance of 1cm each entering a depth of 2-4 mm on the entire scalp.
All patients will be on a background therapy of 5% minoxidil solution, oral finasteride 1 mg per day and multivitamin supplements. Four sitting at 2 weekly intervals will be done and patient will be followed up for 3 months. |