| CTRI Number |
CTRI/2023/05/052909 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the efficacy of low dose oral minoxidil versus 5% topical minoxidil versus 5% topical minoxidil and Platelet rich plasma procedure combination in patients with androgenetic alopecia |
|
Scientific Title of Study
|
A randomised three-armed comparative trial to study the efficacy of low dose oral minoxidil 2.5mg once daily versus 5% topical minoxidil twice daily versus 5% topical minoxidil twice daily +PRP combination in patients with androgenetic alopecia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janaani P |
| Designation |
PG student |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Romm no. 5011, Department of Dermatology, 5th floor, New OPD,
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
09384337014 |
| Fax |
|
| Email |
janaani2605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sendhil Kumaran |
| Designation |
Consultant |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Room no.5009, Department of dermatology, 5th floor, New OPD, PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
09384337014 |
| Fax |
|
| Email |
drsen_2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Janaani P |
| Designation |
PG student |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Room no.5011, 5th floor, Department of dermatology, New OPD, PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
09384337014 |
| Fax |
|
| Email |
janaani2605@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, Postgraduate Institute of Medical education and research |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Dermatology,
Postgraduate institute of medical education and research |
| 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 |
| Janaani P |
Postgraduate Institute of Medical Education and Research |
New OPD, 5th floor, room no. 5011, department of dermatology PGIMER
Chandigarh
CHANDIGARH |
09384337014
janaani2605@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L648||Other androgenic alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral minoxidil |
Low dose oral minoxidil 2.5mg given once daily for 6 months |
| Comparator Agent |
PRP |
Platelet rich plasm (PRP) done once monthly for 4 months and topical minoxidil 5% applied twice daily for 6 months |
| Comparator Agent |
Topical minoxidil |
5% topical minoxidil 1 ml applied twice daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
All androgenetic alopecia patients from Norwood Hamilton grade 3-5 are recruited. |
|
| ExclusionCriteria |
| Details |
Patients suffering from other hair disorders, hypotensive episodes, irritant dermatitis to minoxidil, keloidal tendency and bleeding disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients showing improvement in modified Norwood-Hamilton scale by 1 grade in each group at end of 24 weeks |
assessed at baseline, 4th month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Videodermoscopic assessment as proportion of patients showing 25% increase in hair density 25% decrease in hair diameter diversity and 25% decrease in number of vellus hair/mm2 by end of 24 weeks. Change in population of natural (CD25 high) and induced (CD25 low) T reg cells using Fluorescent activated cell sorting change in NOTCH pathway jagged 1 SOX 9 expression in hair follicle using immunofluorescence pre and post treatment |
assessment done at baseline, 16 weeks and 24 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
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2023 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomised comparitive three-armed trial to study the efficacy of low dose oral minoxidil 2.5mg once daily versus 5% topical minoxidil twice daily versus 5% topical minoxidil twice daily and PRP combination in androgenetic alopecia. Patient followed up for 6 months, where improvement assessed using clinical photographs and videodermoscope. 5 patients of each group will be randomly selected for biopsy to study the nature of Treg cells and its signalling pathways post treatment. |