| CTRI Number |
CTRI/2025/07/091303 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see if exosome therapy can help people with hair loss (alopecia) grow back their hair |
|
Scientific Title of Study
|
The Role of Exosomes in Hair Follicle Growth: A Novel Therapeutic Approach for Alopecia |
| 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 Kumar Rakshak Anand |
| Designation |
Professor and Head |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9711410024 |
| Fax |
|
| Email |
gr8doctor41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeraj Bansal |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9971338761 |
| Fax |
|
| Email |
doc.neerajbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeraj Bansal |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9971338761 |
| Fax |
|
| Email |
doc.neerajbansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College |
|
|
Primary Sponsor
|
| Name |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Sector – 43, Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana Faridabad HARYANA 121004 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kumar Rakshak Anand |
Manav Rachna Dental College |
Room no - QG43, Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Sector – 43, Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana - 121004
Faridabad
HARYANA |
9711410024
rakshak.sds@mrei.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manav Rachna Dental College |
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 |
Exosomes |
Intra-dermal injection of platelet-derived exosome-enriched plasma into alopecic scalp areas. Administered once every 2 weeks for a total of 3 sittings. |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with mild to severe alopecia
No history of other scalp disorders, autoimmune diseases, or active scalp infections
Willing to comply with study protocols and follow-up visits |
|
| ExclusionCriteria |
| Details |
History of chemotherapy or radiation therapy within the last year
Presence of active skin or scalp infections
Pregnant or breastfeeding women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hair density (visually assessed) |
3 months and 6 months after last injection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life using patient-reported outcomes |
At 6 months after the last injection of exosome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This is a single-center, prospective, observational clinical study designed to evaluate the therapeutic efficacy of exosome-based treatment in patients with alopecia. A total of 30 participants will receive intra-dermal injections of platelet-derived exosome-enriched plasma administered at two-week intervals for a total of three sessions. The primary objective is to assess the change in hair density visually at 3 and 6 months following the final injection. Secondary outcomes include evaluation of quality of life using patient-reported outcome measures assessed at 6 months post-treatment. The study aims to explore the regenerative potential of exosomes in promoting hair follicle growth and improving overall scalp condition in alopecia patients. |