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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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 â€œComparative interventional study” To compare the efficacy and side effects of stromal vascular fraction‐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 hairfolliclesIn 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 SVF‐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.


 
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