| CTRI Number |
CTRI/2024/03/063524 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Platelet rich plasma in male female an androgenetic alopecia |
|
Scientific Title of Study
|
A randomised prospective case control study on platelet rich plasma in male androgenetic alopecia and female pattern hair loss, and to compare pre and post treatment trichoscopic feature in male androgenetic alopecia female pattern hairloss |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhijeet Kumar Jha |
| Designation |
Assistant Professor |
| Affiliation |
Patna medical College |
| Address |
Department of Skin and VD, SKIN OPD, ROOM NO.!, PATNA MEDICAL COLLEGE, ASHOK RAJPATH
Patna
BIHAR
800002
India |
| Phone |
9631444797 |
| Fax |
|
| Email |
drabhijeetjha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhijeet Kumar Jha |
| Designation |
Assistant Professor |
| Affiliation |
Patna medical College |
| Address |
Department of Skin and VD, SKIN OPD, ROOM NO.!, PATNA MEDICAL COLLEGE, ASHOK RAJPATH
Patna
BIHAR
800002
India |
| Phone |
9631444797 |
| Fax |
|
| Email |
drabhijeetjha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhijeet Kumar Jha |
| Designation |
Assistant Professor |
| Affiliation |
Patna medical College |
| Address |
Department of Skin and VD, SKIN OPD, ROOM NO.!, PATNA MEDICAL COLLEGE,ASHOK RAJPATH
Patna
BIHAR
800002
India |
| Phone |
9631444797 |
| Fax |
|
| Email |
drabhijeetjha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abhijeet Kumar Jha |
| Address |
Room no1, SKIN OPD,Department of Skin and VD, Patna Medical College, Ashok Rajpath, Patna-800002 |
| Type of Sponsor |
Government medical college |
|
|
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 Abhijeet Kumar Jha |
Patna Medical College |
Department of Skin and VD Patna medical College, Ashok Rajpath, Patna
Patna
BIHAR |
9631444797
drabhijeetjha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patna Medical College, Patna, Ashok Rajpath, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L648||Other androgenic alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline |
Intrademal injection in male and female pattern hairloss at 4 week, 8 week, 12 week |
| Intervention |
Platelet rich plasma |
Intrademal injection on scalp in male and female androgenetic alopecia at 4 week, 8 week and 12 week
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Treatment naive
Grade 2-5 Male Androgenetic alopecia (Norwood hamilton scale)
Grade 2-5 Female Androgenetic alopecia (Sinclair Scale) |
|
| ExclusionCriteria |
| Details |
All pregnant females
Those on any other hormonal therapy
Grade 6 and 7 of hamilton norwood AGA patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of platelet rich plasma in male and female andriogenetic alopecia in 100 patients |
Baseline, 4 weeks, 8weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effect |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "190"
Final Enrollment numbers achieved (India)="190" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Male and Female androgenetic alopecia [MAGA and FAGA] is characterised by decreased hair scalp density and follicle miniaturisation of hair follicle. Topical minoxidil in female AGA and topical mionoxidil and oral finasteride are the only FDA approved therapy for female and male AGA. Platelet rich plasma is a new and promising option to treat MAGA and FAGA, randomised controlled trials in indian patients are lacking. We will recruit 100 patient with grade 2-5 MAGA and FAGA for the study. Safety and efficacy of PRP in FAGA and MASGA will be studied based on global photographic assessment and trichoscopy in piolarised mode will be done in each case during 4 week follow up. Changes in hair density and number will be noted. |