| CTRI Number |
CTRI/2025/05/087617 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing PRP and Growth Factor Therapy for Hair Loss in Androgenic Alopecia |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF PLATELET-RICH PLASMA WITH GROWTH FACTOR CONCENTRATE IN THE MANAGEMENT OF ANDROGENIC ALOPECIA – A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
HAIR-GAIN Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Palak Chouhan |
| Designation |
Post graduate student |
| Affiliation |
Geetanjali Dental and Research Institute |
| Address |
MANAVA KHEDA GEETANJALI UNIVERSITY GEETANJALI MEDICITY NH8 GIRWA UDAIPUR Rajasthan 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
8890787946 |
| Fax |
|
| Email |
palak2000.pc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shallu Bansal |
| Designation |
Professor and Head |
| Affiliation |
Geetanjali Dental and Research Institute |
| Address |
MANAVA KHEDA GEETANJALI UNIVERSITY GEETANJALI MEDICITY NH8 GIRWA UDAIPUR Rajasthan 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9116155666 |
| Fax |
|
| Email |
drshallu23@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shallu Bansal |
| Designation |
Professor and Head |
| Affiliation |
Geetanjali Dental and Research Institute |
| Address |
MANAVA KHEDA GEETANJALI UNIVERSITY GEETANJALI MEDICITY NH8 GIRWA UDAIPUR Rajasthan 313001
RAJASTHAN
313001
India |
| Phone |
9116155666 |
| Fax |
|
| Email |
drshallu23@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Palak Chouhan |
| Address |
Geetanjali Dental College and Research Institute |
| 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 |
| Shallu Bansal |
Geetnajali Dental And Research Institute |
MANAVA KHEDA GEETANJALI UNIVERSITY GEETANJALI MEDICITY NH8 GIRWA UDAIPUR Rajasthan 313001
Udaipur
RAJASTHAN |
9116155666
drshallu23@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethical Committee Geetanjali University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
study group 1 in this GFC for the management of androgenic alopecia |
10 ml of venous autologous whole blood will be collected into GFC tubes. The blood will be gently mixed by inverting the tube 6-10 times and then allowing it to stand for approximately 30 minutes. The GFC treatment helps activate platelets by Wockhardt’s proprietary platelet-activating solution present in the tube and releasing PDGF, VEGF, EGF, and IGF-1 from the platelets now these tubes will be centrifuged at 3400 RPM for 10 mins at room temperature. The portion of plasma will be taken and injected intra-dermally with the help of insulin syringe through multiple small injections in a linear pattern 1cm apart over the scalp. |
| Comparator Agent |
Study group 2 in this PRP for the management of androgenic alopecia |
The PRP will be prepared with single spin technique. 10 ml of venous autologous whole blood will be collected into tubes containing tri-sodium citrate as anticoagulants and centrifuged at 3000 RPM for 10 mins at room temperature. The portion of plasma will be taken and injected intra-dermally with the help of insulin syringe through multiple small injections in a linear pattern 1cm apart over the scalp. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age of 20-65 years of both genders.
2. Type I and Type II Patients indicated for the management of androgenic Alopecia as per Bouhanna’s classification for male and Ludwig’s classification for female
3. Healthy patients falling under ASA I and ASA II
4. Subjects able and willing to provide written informed consent and compliant with study procedure.
|
|
| ExclusionCriteria |
| Details |
1. Patients who had not received any topical or systemic treatment for their hair loss during the last 3 months
2. Patient with history of having anticoagulant therapy
3. Patients having history of autoimmune disorder, haematological disorder and platelet dysfunction syndrome.
4. Patients with a history of immunosuppression (malignancy, chemotherapy, steroid therapy), dermatological acute infections and diseases other than androgenic alopecia affecting the scalp.
5. Patient is under regular analgesics and anti-depressants.
6. Having previous history of radiation therapy in the head and neck region.
7. Pregnant and nursing women.
8. Patients with a history of hair transplant.
9. Patient having tendency for the keloid formation.
10. Patient who has already received PRP and GFC treatment for more than 3 sittings within 3 months
11. Patients with the history of immunodeficiency virus (HIV, hepatitis B and hepatitis C)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Preoperative:
1. Hair-pull test
2. Hair density with the help of trichoscope
3. Patient satisfaction
Immediate postoperative:
1. Pain on visual analogue scale while injecting PRP or GFC
Postoperative:
1. Hair-pull test
2. Hair density with the help of trichoscope
3. Patient satisfaction
4. Investigator satisfaction
|
Day O and Postoperatively On 1st, 2nd, 3rd and 4th month postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any other complication |
On 1st, 2nd, 3rd and 4th month postoperatively |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
18/07/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Androgenic alopecia (AGA) is a progressive, nonscarring hair loss condition affecting up to 80% of men and 40% of women, with noticeable patterns and genetic predisposition. While FDA-approved treatments like minoxidil and finasteride are available, their limited efficacy and side effects prompt the need for alternative therapies. Platelet-rich plasma (PRP) therapy, rich in growth factors such as PDGF, VEGF, TGF, and IGF, has shown potential in stimulating hair follicle stem cells. Growth Factor Concentrate (GFC) is a modified PRP technique offering a higher concentration of these growth factors, showing promising results in hair regrowth and follicular regeneration. However, comparative data between PRP and GFC in the Indian population is limited. This randomized controlled trial aims to compare the efficacy of PRP and GFC therapies in managing AGA. The null hypothesis states no difference between the two treatments, while the alternate hypothesis suggests GFC is superior. |