| CTRI Number |
CTRI/2024/09/073393 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ANALYSIS AND ASSESSMENT OF HAIR DIAMETER AND HAIR DENSITY WITH IN 650 PATIENTS WITH NON-CICATRICIAL ALOPECIA WITH MULTIMODAL THERAPY |
|
Scientific Title of Study
|
Retrospective Analysis And Assessment Of Non Surgical Hair Restoration In Patients With Non Cicatricial Alopecia With Multimodal Therapy |
| 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 Kamal Kumar |
| Designation |
PROFFESOR & HOD |
| Affiliation |
RAJA RAJESWARI MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY RAJA RAJESWARI MEDICAL COLLEGE BANGALORE
Bangalore
KARNATAKA
560074
India |
| Phone |
9755553146 |
| Fax |
|
| Email |
drkamalkumar1975@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shobhit Maheshwari |
| Designation |
Pg Resident |
| Affiliation |
RAJA RAJESWARI MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY RAJA RAJESWARI MEDICAL COLLEGE BANGALORE
Bangalore
KARNATAKA
560074
India |
| Phone |
9755553146 |
| Fax |
|
| Email |
shobhit4594@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KAMAL KUMAR |
| Designation |
PROFFESOR & HOD |
| Affiliation |
RAJA RAJESWARI MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY RAJA RAJESWARI MEDICAL COLLEGE BANGALORE
Bangalore
KARNATAKA
560074
India |
| Phone |
9755553146 |
| Fax |
|
| Email |
drkamalkumar1975@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJA RAJESHWARI MEDICAL COLLEGE AND K2 HAIR AND AESTHETIC PVT LTD BANGALORE KARNATAKA INIDA 560074 |
|
|
Primary Sponsor
|
| Name |
Shobhit Maheshwari |
| Address |
Department of plastic surgery RRMCH Bangalore And K2 Hair and Aesthetic PVT LTD |
| 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 |
| Shobhit Maheshwari |
Raja Rajeswari Medical College And K2 Hair And Aesthetic Pvt Ltd |
Department of plastic surgery opd room no 1 raja rajeswari medical college bangalore
Bangalore
KARNATAKA |
9755553146
shobhit4594@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Raja Rajeshwari medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal build and nutrition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female patients more than 18 years of age, and giving consent to be a part of the study
2. Patients with androgenetic alopecia grade II-VI of Modified Norwood - Hamilton criteria for Male pattern hair loss and Ludwig Criteria for Female Pattern hair loss.
3. Patients with platelet count more than or equal to 1.5 lakhs/ microlitre.
4. Patients with complaints of Hairfall/Hairloss. |
|
| ExclusionCriteria |
| Details |
Patients with current dermatological diseases of scalp (Tinea Capitis, Folliculitis, Pediculosis Capitis, Lichen Planus, Contact dermatitis, Psoriasis).
1. Patients with tendency to form keloids.
2. Patients who are taking oral finasteride for treatment of androgenetic alopecia or should have stopped 6 months back.
3. Patients with platelet function disorder or on anti-coagulation therapy.
4. Hemodynamic instability.
5. History of use of platelet-rich plasma or surgical correction of hair loss in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the efficacy of autologous platelet rich plasma with multimodal therapy in non cicatricial alopecia. |
To assess the hair diameter and density at baseline, 4th session and 8th session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hair density and hair diameter significant growth is seen after 8 sessions of multimodal therapy |
After 8 sessions |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
16/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="7"
Months="0"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
TITLE - RETROSPECTIVE ANALYSIS AND ASSESSMENT OF NON-SURGICAL HAIR RESTORATION IN PATIENTS WITH NON-CICATRICIAL ALOPECIA WITH MULTIMODAL THERAPY
Objective - To estimate the efficacy of autologous platelet rich plasma with multimodal therapy in non cicatricial alopecia.
OUTCOME - Significant Increase in Hair Density and Hair Diameter after multimodal therapy after completion of 8 sessions. |