| CTRI Number |
CTRI/2015/01/005482 [Registered on: 30/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
04/02/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of dutasteride and finasteride for the treatment of male pattern hair loss in men |
|
Scientific Title of Study
|
Randomized, controlled, open label study of dutasteride versus finasteride in men 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 |
Dr Sujit Shanshanwal |
| Designation |
Resident |
| Affiliation |
Lokmanya Tilak Municipal Medical College & General Hospital |
| Address |
OPD 16, New OPD Buidling
Lokmanya Tilak Municipal Medical College,
Dr Babasaheb Ambedkar Road, Sion West, Mumbai
A/10, Saket Prem, 294,
Sher-E-Punjab Society,
Off Mahakali Caves Road,
Andheri(East)
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9773541179 |
| Fax |
|
| Email |
shanshanwal.sujit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachita Dhurat |
| Designation |
Professor & Head of Department |
| Affiliation |
Lokmanya Tilak Municipal Medical College & General Hospital |
| Address |
OPD 16, New OPD Buidling
Lokmanya Tilak Municipal Medical College,
Dr Babasaheb Ambedkar Road, Sion West, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870390057 |
| Fax |
|
| Email |
rachitadhurat@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sujit Shanshanwal |
| Designation |
Resident Doctor |
| Affiliation |
Lokmanya Tilak Municipal Medical College & General Hospital |
| Address |
OPD 16, New OPD Buidling
Lokmanya Tilak Municipal Medical College,
Dr Babasaheb Ambedkar Road, Sion West, Mumbai
A/10, Saket Prem, 294,
Sher-E-Punjab Society,
Off Mahakali Caves Road,
Andheri(East)
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9773541179 |
| Fax |
|
| Email |
shanshanwal.sujit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College & General Hospital |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal Medical College General Hospital |
| Address |
OPD 16, New OPD Buidling Lokmanya Tilak Municipal Medical College, Dr Babasaheb Ambedkar Road, Sion West, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Type of Sponsor |
Government 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 |
| Sujit Shanshanwal |
Lokmanya Tilak Municipal Medical College & General Hospital |
OPD 16, New OPD Buidling Lokmanya Tilak Municipal Medical College, Dr Babasaheb Ambedkar Road, Sion West, Mumbai Mumbai MAHARASHTRA 400022 India
Mumbai
MAHARASHTRA |
9773541179
shanshanwal.sujit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lokmanya Tilak Municipal Medical College and Lokmanya General Hospital Staff and Research Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Androgenetic Alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dutasteride |
0.5 mg oral Dutasteride, OD (once daily), for six months
|
| Comparator Agent |
Finasteride |
1 mg oral Finasteride, OD (once daily), for six months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
AGA with Grade 3v(vertex), grade IV or grade V of Modified Hamilton Norwood
AGA with female pattern hair loss - graded as F1, F2 or F3 as per BASP classification.
Patient who are willing to give consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Use of minoxidil within previous 6 months
Use of drugs with androgenetic/anti-androgenetic properties within previous 6 months
History of breast cancer/ prostate cancer/ first degree relative with prostate cancer before the age of 50
Use of drugs that cause hypertrichosis (phenytoin, acetazolamide, cyclosporine, diazoxide, psoralens, minoxidil, penicillamine, streptomycin, cortisone) and hypotrichosis(anti-coagulants, retinoids, lithium, beta blockers) in the past 6 months
Uncontrolled Diabetes mellitus or hypertension
Chronic smokers or tobacco chewers
Hair Transplantation or hair weaving within 6 months
Light or laser treatment of scalp within previous 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total, thick and thin hair count |
Basline and 24 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blinded and non-blinded evaluation of global photographs |
24 weeks |
| Inter-investigator comparison of Global photography evauation |
24 weeks |
| Subjective evaluation |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
09/01/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate and compare the efficacy and
safety of dutasteride versus finasteride over 24 weeks in men with androgenetic
alopecia. |