| CTRI Number |
CTRI/2025/03/082253 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of novel injectable platelet rich fibrin versus conventional microneedling in male androgenetic alopecia |
|
Scientific Title of Study
|
Efficacy of injectable platelet rich fibrin iPRF with topical 5 percent minoxidil versus microneedling with topical 5 percent minoxidil in male androgenetic alopecia A tertiary care hospital based randomised controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farkhanda Sofi |
| Designation |
Post graduate student |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR |
| Address |
ROOM NO: 226, Dept of dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh.
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9559116869 |
| Fax |
|
| Email |
farkhandasofi11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Kumar Gupta |
| Designation |
Professor and Head, dept. of dermatology, AIIMS Gorakhpur |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR |
| Address |
ROOM NO: 226, Dept of dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh.
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9838844937 |
| Fax |
|
| Email |
dr.sunil_30@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Farkhanda Sofi |
| Designation |
Post graduate student |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR |
| Address |
ROOM NO: 226, Dept of dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh.
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9559116869 |
| Fax |
|
| Email |
farkhandasofi11@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Gorakhpur |
|
|
Primary Sponsor
|
| Name |
Dr FARKHANDA SOFI |
| Address |
Room no 310, married residents hostel, AIIMS, Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh, India. PIN code: 273008 |
| 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 Farkhanda Sofi |
All India Institute of Medical Sciences Gorakhpur |
Room no 226, OPD block, dept. of dermatology and venereology, AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH |
9559116869
farkhandasofi11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Gorakhpur |
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 |
Injectable platelet rich fibrin (iPRF) |
Injectable platelet rich fibrin (iPRF) monthly sessions for 6 months plus topical 5 % minoxidil topically twice daily. the total duration of intervention will be monthly for a total of 6 months and further 6 month follow up will be done. |
| Comparator Agent |
Microneedling |
Microneedling with minoxidil monthly sessions for 6 months plus topical 5 % MINOXIDIL TWICE DAILY. the total duration of intervention will be monthly for a total of 6 months and further 6 month follow up will be done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Androgenetic alopecia Norwood Hamilton grade III- V
No history of treatment with PRP or Finasteride in the past 6 months.
No history of minoxidil oral or topical for at least 2 months prior to study. |
|
| ExclusionCriteria |
| Details |
Active scalp infections or skin diseases (psoriasis, eczema).
Patients on systemic immunosuppressive or steroid therapy.
Known hypersensitivity to minoxidil or any other study components.
Prior hair transplantation.
Any coagulation disorder or thrombocytopenia |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hair density as indicated by hair count/cm2 by trichoscopy. |
At 0, 6 and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference between the response of injectable platelet rich fibrin (iPRF) and microneedling in different stages of androgenetic alopecia.
maintainence period of response achieved for a further 6 month follow up period.
dermatology life quality index assessment (DLQI)
|
0, 6. 12 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
14/03/2025 |
| 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="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
As PRP is an established treatment option for androgenetic alopecia, and injectable platelet rich fibrin is a 2 nd generation PRP which has been found to have higher concentration of growth factors as compared to PRP, we are comparing the efficacy of injectable platelet rich fibrin ( iPRF) vs microneedling (as a standard comparator) in androgenetic alopecia. Patients will undergo monthly sessions of iPRF or microneedling respectively for 6 months and further follow up will be done for a further 6 month period. Moreover, minoxidil 5 % will be applied by patients of both the arms of the trial twice daily. We will assess hair count by trichoscopy at 0,6 months and 12 months. |