| CTRI Number |
CTRI/2022/03/041364 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
20/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Trial To Study the Effects and Safety Of Two Drugs Minoxidil and Finasteride in Male Androgenic Alopecia |
|
Scientific Title of Study
|
Study Of Efficacy And Safety Of Oral Minoxidil(2.5MG) V/S Oral Finasteride (1MG) in Male Androgenic Alopecia-A Double Blind Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohak Arora |
| Designation |
PG student |
| Affiliation |
Krishna institute of medical sciences |
| Address |
Department of dermatology
OPD 29
Krishna institute of medical sciences Karad
415539
Satara
MAHARASHTRA
415539
India |
| Phone |
9999525693 |
| Fax |
|
| Email |
mohak.arora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balkrishna nikam |
| Designation |
associate professor |
| Affiliation |
Krishna institute of medical sciences |
| Address |
Department of dermatology
OPD 29
Krishna institute of medical sciences Karad
415539
Satara
MAHARASHTRA
415539
India |
| Phone |
8275061393 |
| Fax |
|
| Email |
nitaldermpath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohak Arora |
| Designation |
PG student |
| Affiliation |
Krishna institute of medical sciences |
| Address |
Department of Dermatology
OPD 29
Krishna institute of medical sciences Karad
415539
Satara
MAHARASHTRA
415539
India |
| Phone |
9999525693 |
| Fax |
|
| Email |
mohak.arora@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Institute of medical sciences
Nh-4 pune bangalore highway
agashivnagar Malkapur karad
415539 |
|
|
Primary Sponsor
|
| Name |
Krishna institute of medical sciences |
| Address |
Krishna institute of medical sciences Karad 415539 |
| 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 |
| Mohakarora |
Krishna Institute of Medical Sciences |
Department of dermatology
OPD 29
NH 4 pune bangalore highway
Agashivnagar ,Malkapur
Maharashtra 415539
Satara
MAHARASHTRA |
9999525693
mohak.arora@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: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
use of oral finasteride and oral minoxidil in androgenic alopecia |
dose finasteride - 1mg
dose of minoxidil-2.5mg
frequency- Once daily
Route - oral
Duration of treatment- 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Male patient comes with history or clinical findings suggestive of androgenic alopecia.
2. Age group more than 18 years of age and less than 50 years of age
3. Hamilton grade 2-6
4. Have given written consent before investigation and starting the drug.
5. Be able and willing and fit , in the view of investigator , to comply all study procedures
|
|
| ExclusionCriteria |
| Details |
1. Patient who is hypotensive or hypertensive
2. Patients with grade 1 or grade 7 alopecia.
3. Patient with cardiac diseases (including angina, coronary artery disease, recent or acute myocardial infarction, pericardial effusion)
4. Patients with cerebrovascular diseases
5. Patients with deranged liver and kidney function.
6. Patients allergic to finasteride or minoxidil.
7. Patient on any treatment for androgenic alopecia for last 2 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.average hair thickness improvement by more than 10 percent
2.Increase in terminal vellus hair ratio. |
Baseline
4 weeks
8 weeks
12 weeks
16 weeks
20 weeks
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical photography |
Baseline
4 weeks
8 weeks
12 weeks
16 weeks
20 weeks
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
04/04/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Topical minoxidil is FDA approved treatment for androgenic alopecia but oral minoxidil is being used and its efficacy is being tested in many studies but no study is being done to compare the efficacy between oral finasteride and oral minoxidil.Therefore comparative study between oral minoxidil and oral finasteride will resulting in establishing a more effective drug in treatment of androgenic alopecia. |