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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
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