| CTRI Number |
CTRI/2026/04/107424 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Using Injectable Platelet-Rich Fibrin (i-PRF) to Treat Under-Eye Aging: A Clinical Study |
|
Scientific Title of Study
|
A Prospective Study to Evaluate the Efficacy and Safety of Injectable Platelet-Rich Fibrin (i-PRF) in the Management of Periorbital Aging Changes: Clinical, Dermoscopic, and Patient-Reported Outcome Assessment. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manasi Mukund Joshi |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Medical College, Nagpur |
| Address |
Department of Dermatology, Datta Meghe Medical college, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9404662563 |
| Fax |
|
| Email |
manasijoshi.m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabiha Quazi |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Medical College, Nagpur |
| Address |
Department of Dermatology, Datta Meghe Medical college, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8806294039 |
| Fax |
|
| Email |
drsabiha.derm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manasi Mukund Joshi |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Medical College, Nagpur |
| Address |
Department of Dermatology, Datta Meghe Medical college, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9404662563 |
| Fax |
|
| Email |
manasijoshi.m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Medical College, Wanadongri, Hingna Road, Nagpur, India-441110 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Medical College |
| Address |
Department of Dermatology, Datta Meghe Medical College, Wanadongri, Hingna Road, Nagpur, India-441110 |
| Type of Sponsor |
Private 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 Manasi Mukund Joshi |
Shalinitai Meghe Hospital and Research Centre |
Procedure Room of Department of Dermatology, Wanadongri, Nagpur
Nagpur
MAHARASHTRA |
09404662563
manasijoshi.m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DATTA MEGHE MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with periorbital ageing changes. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 30–60 years with clinical signs of periorbital aging (e.g., fine lines,
volume loss, and pigmentation).
2. Fitzpatrick skin types III–V.
3. Willingness to get i-PRF injections and attend follow-up appointments.
4. Participants who agree to take part in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with active dermatological or systemic infections.
2. History of bleeding disorders or anticoagulant therapy.
3. Autoimmune diseases or immunosuppressed states.
4. History of cosmetic procedures (e.g., fillers, botulinum toxin) in the periorbital region
in the past 6 months.
5. Pregnant or lactating women.
6. Known hypersensitivity to any materials used in the procedure.
7. Inability or unwillingness to comply with study protocol. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in periorbital aging changes assessed using the Wrinkle Severity Rating Scale (WSRS) and Visual Analog Scale (VAS). |
Baseline, 4 weeks, and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/04/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The study aims to collect strong clinical and dermoscopic proof about how safe and effective injectable Platelet-Rich Fibrin (i-PRF) is in treating periorbital aging. If it works well, it might give people a low-cost and natural option instead of synthetic fillers or laser treatments. The results could help create treatment guidelines and make it easier to include regenerative therapies in day to day aesthetic dermatology practices. |