World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2015/01/005482
Date of registration: 30-01-2015
Prospective Registration: No
Primary sponsor: Lokmanya Tilak Municipal Medical College General Hospital
Public title: Comparison of dutasteride and finasteride for the treatment of male pattern hair loss in men
Scientific title: Randomized, controlled, open label study of dutasteride versus finasteride in men with androgenetic alopecia
Date of first enrolment: 09-01-2013
Target sample size: 90
Recruitment status: Completed
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10842
Study type:  Interventional
Study design:  Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Outcome Assessor Blinded
 
Phase:  Phase 3/ Phase 4
Countries of recruitment
India
Contacts
Name: Sujit Shanshanwal   
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) 400022 Mumbai, MAHARASHTRA India
Telephone: 9870390057
Email: rachitadhurat@yahoo.co.in
Affiliation:  Lokmanya Tilak Municipal Medical College & General Hospital
Name: Dr Rachita Dhurat   
Address:  OPD 16, New OPD Buidling Lokmanya Tilak Municipal Medical College, Dr Babasaheb Ambedkar Road, Sion West, Mumbai 400022 Mumbai, MAHARASHTRA India
Telephone: 9870390057
Email: rachitadhurat@yahoo.co.in
Affiliation:  Lokmanya Tilak Municipal Medical College & General Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 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.


Exclusion criteria: 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



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- Androgenetic Alopecia
Intervention(s)
Intervention1: Dutasteride: 0.5 mg oral Dutasteride, OD (once daily), for six months

Control Intervention1: Finasteride: 1 mg oral Finasteride, OD (once daily), for six months

Primary Outcome(s)
Total, thick and thin hair countTimepoint: Basline and 24 Weeks
Secondary Outcome(s)
Subjective evaluationTimepoint: 24 weeks
Inter-investigator comparison of Global photography evauationTimepoint: 24 weeks
Blinded and non-blinded evaluation of global photographsTimepoint: 24 weeks
Secondary ID(s)
NIL
Source(s) of Monetary Support
Lokmanya Tilak Municipal Medical College & General Hospital
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 04/01/2013
Contact:
Lokmanya Tilak Municipal Medical College and Lokmanya General Hospital Staff and Research Society
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history