| CTRI Number |
CTRI/2025/03/083278 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Effects of SVF-Enriched PRP and Standard PRP for Treating Male Pattern Baldness |
|
Scientific Title of Study
|
Comparative study to know the efficacy and safety of stromal vascular fraction-enriched platelet-rich plasma therapy versus platelet rich plasma therapy in the treatment of Androgenetic 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 Leena Raveendra |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
room no 107,department of Dermatology,Rajarajeshwari medical college and hospital 202,kambipura ,Mysore road , Bangalore -560075
Bangalore KARNATAKA 560074 India |
| Phone |
9845103089 |
| Fax |
|
| Email |
cbleena@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Leena Raveendra |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
room no 107, Department of Dermatology, Rajarajeswari Medical College and Hospital 202, Kambipura, Mysore Road, Bangalore -560075
Bangalore KARNATAKA 560074 India |
| Phone |
9845103089 |
| Fax |
|
| Email |
cbleena@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Leena Raveendra |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Room no 107, Department of Dermatology,Rajarajeshwari medical college and hospital 202,kambipura ,Mysore road , Bangalore -560075
Bangalore KARNATAKA 560074 India |
| Phone |
9845103089 |
| Fax |
|
| Email |
cbleena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dean, Rajarajeshwari medical college and hospital, No 202, Kambipura, mysore road, Kengeri, Bangalore-74 |
|
|
Primary Sponsor
|
| Name |
RajaRajeswari Medical College and Hospital |
| Address |
RajaRajeswari Medical College and Hospital
202, Kambipura, Mysore Road, Bangalore-560 074., Karnataka, India. |
| 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 Leena raveendra |
Rajarajeshwari medical college and hospital |
Room no-1117,department of dermatology, Ccl building,
Bangalore-560074
KARNATAKA Bangalore KARNATAKA |
9845103089
cbleena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAJARAJESHWARI MEDICAL COLLEGE AND HOSPITAL -INSTITUTIONAL ETHICS AND COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PRP |
PRP once a month for 3 months |
| Intervention |
Stromal vascular fraction enriched Platelet rich plasma (SVF +PRP) |
SVF + PRP once a month for 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
96.00 Year(s) |
| Gender |
Both |
| Details |
1.Hamilton score 2-6 in male patients,ludwing score
1-3 in female patients
2.patients not on any treatment for androgenetic alopecia for past 1 month. |
|
| ExclusionCriteria |
| Details |
1 Patient with malignancy, autoimmune disease
2 Pregnancy
3 History of keloid formation
4 Patients with platelet disorders,
thrombocytopenia, sepsis.
5 Patients currently on anticoagulant therapy,
6 Patients on chemotherapy during the last 5years |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hair growth is the primary outcome the improvement will be assessed using pre†and post†treatment photographs, Physicians global assessment (PhGAS) scores, Patients global assessment score(PaGAS) and trichoscan. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Alopecia quality of life assessment will be assessed by using dermatology life quality index(DLQI). |
Baseline,12 weeks & 16 weeks. |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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)
|
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
|
It’s a “Comparative interventional study†To compare the efficacy and side effects of stromal vascular fractionâ€enriched platelet†rich plasma therapy versus platelet rich plasma therapy in the treatment of Androgentic Alopecia . Androgenetic alopecia is characterized by progressive patterned hair loss. AGA is hereditary and the circulating androgen hormones may cause the conversion of terminal hair to vellus by miniaturization of hairfollicles. In the treatment of androgenetic alopecia, currently minoxidil and oral finasteride, are the only two therapeutic drugs approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). They must be used lifelong and daily, as its interruption is followed by gradual return of hair loss. They may have limited degree of improvement in some patients. Platelet rich plasma(PRP) has a good potential in treatment of AGA and has gained popularity since last decade. PRP contains many growth factors that can activate the proliferative phase of hair bulge area of the follicles Adipose tissue derived stromal vascular fraction(SVF), is an emerging treatment for AGA. It contains non cultured regenerative cells -mesenchymal cells or adipose cells that can “home†to the site of injury. The restoration of hair with PRP in AGA can be augmented by enriching PRP with SVF. In our study we want to know if enriching PRP with SVF gives better hair restoration in AGA as compared with PRP alone. Each patient will undergo two sessions at an interval of 4 weeks. They will be followed up monthly for 2 months till the last session. After PRP and SVFâ€PRP therapy, the improvement will be assessed using pre†and post†treatment photographs, Physicians global assessment (PhGAS) scores, Patients global assessment score(PaGAS), Alopecia quality of life assessment and trichoscan after every session. Alopecia quality of life assessment will be assessed by using dermatology life quality index(DLQI). DLQI will be performed before the start of treatment and at the end of follow up period. |