| CTRI Number |
CTRI/2023/09/058150 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
28/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Autologous Nanofat transfer] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
FAT THERAPY IN MALE AND FEMALE PATTERN BALDNESS |
|
Scientific Title of Study
|
Evaluation of effectiveness and safety of Nanofat transfer in Androgenetic Alopecia - An 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 |
Varsha M |
| Designation |
Fellowship student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
No.52, Department of Dermatology, Venereology and Leprology, B block, Fort, Krishna Rajendra Rd, Bengaluru, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9686284368 |
| Fax |
|
| Email |
varshamgowda95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Eswari L |
| Designation |
Associate Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
No 52, Department of Dermatology, Venereology and Leprology, B Block, Fort, Krishna Rajendra Rd, Bengaluru, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9845935375 |
| Fax |
|
| Email |
eshwaril@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Varsha M |
| Designation |
Fellowship student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
No 52, Department of Dermatology, Venereology and Leprology, B block, Fort, Krishna Rajendra Rd, Bengaluru, Karnataka
KARNATAKA
560002
India |
| Phone |
9686284368 |
| Fax |
|
| Email |
varshamgowda95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Varsha M |
| Address |
Fort, Krishna Rajendra Rd, Bengaluru, Karnataka |
| 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 |
| Dr Varsha M |
Victoria hospital |
No 52, Department of Dermatology, Venereology and Leprology, B Block, Fort, Krishna Rajendra Rd, Bengaluru, Karnataka
Bangalore
KARNATAKA |
9686284368
varshamgowda95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
Approved |
| VICTORIA HOSPITAL |
Approved |
| VICTORIA HOSPITAL |
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 |
Autologous nanofat transfer |
Fat is extracted from patients thigh under local anaesthesia and tumescent anaesthesia and converted into nanofat which is injected into bald areas of alopecic scalp as 0.1ml per cm2 using 18ml syringe |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to give written informed consent (Annexure 1a, 1b, 1c)
2. Patients above 18 years of age and either sex
3. Patients with clinically and dermoscopically diagnosed as Androgenetic alopecia
4. Patients with BMI < 40kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Patient not willing to give written informed consent
2. Pregnant and lactating women
3. Patients with BMI < 18kg/m2
4. Patients currently suffering from an active autoimmune disease like SLE, Alopecia aerata
5. Patients suffering from any cardiovascular, renal, hematological, pulmonary,
gastrointestinal or central nervous system disorders.
6. Patients with any bleeding or clotting disorders or on antiplatelet therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trichoscopic improvement in hair density and hair diameter |
Baseline, 1 month, 2 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Visual analogue scale
Improvement in global photography |
12 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
20/10/2023 |
| 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
|
Androgenetic alopecia is a type of progressive patterned hair loss. It is
characterized by stepwise miniaturization of the hair follicle, resulting in alteration in the hair
cycle dynamics, leading to vellus transformation of the terminal hair. Nanofat transfer is a new and upcoming treatment option for androgenetic alopecia. The
adipose-derived stem cells have self-renewal capacity and also secrete various growth factors
that have potential for hair growth |