| CTRI Number |
CTRI/2019/09/021467 [Registered on: 30/09/2019] Trial Registered Prospectively |
| Last Modified On: |
28/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
platelet rich plasma and topical minoxidil(5 percent)
fortified with finasteride( 0.1 percent) in the treatment of androgenic alopecia in male patients |
|
Scientific Title of Study
|
A study to compare the efficacy and safety of platelet rich plasma and topical minoxidil(5 percent) fortified with finasteride( 0.1 percent) in the treatment of androgenic alopecia in male patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prof KS Mehta |
| Designation |
HOD and PROFESSOR |
| Affiliation |
DR RPGMC TANDA ,KANGRA,176001 |
| Address |
DEPARTMENT OF DERMATOLOGY,DR RPGMC TANDA AT KANGRA,H.P
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
drkaranindermehta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof KS Mehta |
| Designation |
HOD and PROFESSOR |
| Affiliation |
DR RPGMC TANDA ,KANGRA,176001 |
| Address |
DEPARTMENT OF DERMATOLOGY,DR RPGMC TANDA AT KANGRA,H.P
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
drkaranindermehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof KS Mehta |
| Designation |
HOD and PROFESSOR |
| Affiliation |
DR RPGMC TANDA ,KANGRA,176001 |
| Address |
DEPARTMENT OF DERMATOLOGY,DR RPGMC TANDA AT KANGRA,H.P
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
drkaranindermehta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra prasad medical college and hospital tanda via HP government. |
|
|
Primary Sponsor
|
| Name |
Himachal Pradesh university |
| Address |
Himachal Pradesh university, Summerhill Shimla ,distt Shimla,H.P,171011 |
| Type of Sponsor |
Other [Himachal Pradesh university] |
|
|
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 Hitender Kumar sharma |
Dr RPGMC Tanda,kangra |
Opd no 7 room no.135 Deptt of dermatology,Dr RPGMC Tanda,kangra,Himachal Pradesh,176001
Kangra
HIMACHAL PRADESH |
7807562597
happy.dua92@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 |
platelet rich plasma |
intradermal injections of platelet rich plasma using a 30 gauze insulin syringe 1cm apart in interfollicular areas at 0,1,2,3 and 6 and 12 months. |
| Comparator Agent |
topical minoxidil(5%) fortified with finasteride(0.1%) to be applied 1ml twice daily for 1 year over balding areas of scalp. |
topical minoxidil(5%) fortified with finasteride(0.1%) to be applied 1ml twice daily for 1 year over balding areas of scalp.patients to be followed up at end of every month and assesd on the basis of global photographs and dermatoscopic findings for 1 year. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
age 20 to 40 years,androgenic alopecia grade between 2-4 of norwood hamilton scale,platelets equal to or more than 1.5 lacs per microlitre, |
|
| ExclusionCriteria |
| Details |
dermatological diseases of scalp other than androgenic alopecia,patients with unrealistic expectations from treatment,patirnts with tendency of keloidal formation,patients with hematological or coagulation disorders, patients who are immunosupressed. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical photographs taken at each visit,investigator assessment scale,patients self assessment scale |
every month for 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| various aspects related to sideffects. |
at every month for 1 year. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
01/10/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
a study to compare the efficacy and safety pf platelet rich pasma and topical minoxidil(5%) fortified with finasteride(0.1%) in male pattern baldness over a period of one year |