| CTRI Number |
CTRI/2026/01/101131 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Therapeutic ] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Two Autologous Blood Based Injection treatments for hair loss in Men |
|
Scientific Title of Study
|
Comparison of platelet-rich plasma (PRP) versus injectable platelet-rich fibrin (IPRF) in the treatment of androgenetic alopecia in males-a prospective interventional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAishwarya B N |
| Designation |
Junior Resident/Post Graduate |
| Affiliation |
JJM Medical College |
| Address |
Department of dermatology, Room no. 9, Bapuji OPD Block, JJM Medical college, Davanagere-577004
MCC B Block
Davanagere-577004
Davanagere
KARNATAKA
577004
India |
| Phone |
7996615649 |
| Fax |
|
| Email |
draishwaryabn@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMangala H C |
| Designation |
Professor |
| Affiliation |
JJM MEDICAL COLLEGE |
| Address |
DEPARTMENT OF DERMATOLOGY
VENEREOLOGY AND LEPROSY
J. J. M. MEDICAL COLLEGE
DAVANGERE – 577004.
MCC B Block
Davanagere-577004
Davanagere
KARNATAKA
577004
India |
| Phone |
9886075467 |
| Fax |
|
| Email |
drhcmangala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMangala H C |
| Designation |
Professor |
| Affiliation |
JJM MEDICAL COLLEGE |
| Address |
DEPARTMENT OF DERMATOLOGY
VENEREOLOGY AND LEPROSY
J. J. M. MEDICAL COLLEGE
DAVANGERE – 577004.
MCC B Block
Davanagere-577004
Davanagere
KARNATAKA
577004
India |
| Phone |
9886075467 |
| Fax |
|
| Email |
drhcmangala@gmail.com |
|
|
Source of Monetary or Material Support
|
| JJM MEDICAL COLLEGE, MCC B Block, Davanagere-577004, Karnataka , India |
|
|
Primary Sponsor
|
| Name |
DrAishwarya B N |
| Address |
Department of Dermatology Venereology and Leprosy, JJM Mdical College, Davanagere-577004 , Karnataka , India |
| 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 |
| DrAishwarya B N |
BAPUJI HOSPITAL,Davanagere |
JJM MEDICAL COLLEGE, MCC B BLOCK,DAVANAGERE-577004
Davanagere
KARNATAKA |
7996615649
draishwaryabn@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| J.J.M MEDICAL 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 |
INJECTABLE PLATELET RICH FIBRIN |
•Blood Collection: 20 mL of venous blood
•Centrifugation: Single-spin method at 700 rpm for 5–8 min
•Platelet & Growth Factor Content: Higher than PRP (contains leukocytes and fibrin matrix)
•Injection Technique: Inject 0.1 mL per site (1 cm apart)
|
| Comparator Agent |
PLATELET RICH PLASMA |
•Blood Collection: 20 mL of venous blood
•Centrifugation: Double-spin method (first spin at 1500 rpm for 10 min, second spin at 2500 rpm for 10 min)
•Platelet Concentration: 3–5 times baseline value
•Activation: Calcium chloride/thrombin
•Injection Technique: Inject 0.1 mL of PRP per site (1 cm apart)
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Male patients aged 20–50 years
Diagnosed with AGA (confirmed by clinical examination & trichoscopy)
No satisfactory improvement to standard line of treatment for a period of 6 months
No history of hair restoration surgery in the past year
No active scalp infections or autoimmune scalp disorders
|
|
| ExclusionCriteria |
| Details |
Patients with alopecia other than androgenetic alopecia
History of platelet disorders, coagulopathies, or immunosuppressive conditions
Active scalp infections, seborrheic dermatitis, or psoriasis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine Treatment Efficacy: Establish which treatment-PRP or iPRF provides superior clinical outcomes. |
every 4 weeks for 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare Patient Satisfaction and Side Effects.
Evaluate Hair Growth Outcomes: Compare the effects of PRP and iPRF on hair density and follicular count.
|
every 4 weeks for 4 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/01/2026 |
| 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
|
- This study is a prospective interventional study comparing efficacy of PRP and IPRF in Androgenetic Alopecia in men. Androgenetic Alopecia (AGA) is a common progressive hair loss disorder affecting both men and women. Causes psychological distress and reduced quality of life. Study will be conducted in Bapuji Hospital, Davanagere (JJM medical college Hospital). The primary outcome will be to determine Treatment Efficacy: Establish which treatment-PRP or iPRF provides superior clinical outcomes.The secondary outcome will be to Compare Patient Satisfaction and Side Effects and to evaluate Hair Growth Outcomes: Compare the effects of PRP and iPRF on hair density and follicular count.
- Emerging Regenerative Therapies
PRP (Platelet-Rich Plasma) contains growth factors that stimulate hair growth. Requires anticoagulants, which may dilute platelet concentration. IPRF (Injectable Platelet-Rich Fibrin) does not require anticoagulants and also provides prolonged release of growth factors which is potentially superior in hair regeneration. Knowledge Gap · Limited comparative studies on PRP vs. IPRF in AGA. · Lack of statistical data (mean hair count, standard deviation, response rates). · Need for evidence-based guidance for dermatologists. · Direct comparison of PRP and IPRF in efficacy, safety, and patient satisfaction. · Helps determine the most effective treatment for AGA in the Indian population |