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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:
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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2015/01/005482 |
Date of registration:
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30-01-2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Comparison of dutasteride and finasteride for the treatment of male pattern hair loss in men
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Scientific title:
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Randomized, controlled, open label study of dutasteride versus finasteride in men with androgenetic alopecia |
Date of first enrolment:
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09-01-2013 |
Target sample size:
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90 |
Recruitment status: |
Completed |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10842 |
Study type:
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Interventional |
Study design:
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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
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Phase:
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Phase 3/ Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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Sujit Shanshanwal
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Address:
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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:
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9870390057 |
Email:
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rachitadhurat@yahoo.co.in |
Affiliation:
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Lokmanya Tilak Municipal Medical College & General Hospital |
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Name:
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Dr Rachita Dhurat
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Address:
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OPD 16, New OPD Buidling
Lokmanya Tilak Municipal Medical College,
Dr Babasaheb Ambedkar Road, Sion West, Mumbai
400022
Mumbai, MAHARASHTRA
India |
Telephone:
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9870390057 |
Email:
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rachitadhurat@yahoo.co.in |
Affiliation:
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Lokmanya Tilak Municipal Medical College & General Hospital |
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Key inclusion & exclusion criteria
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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:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Androgenetic Alopecia
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Intervention(s)
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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
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Primary Outcome(s)
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Total, thick and thin hair countTimepoint: Basline and 24 Weeks
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Secondary Outcome(s)
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Subjective evaluationTimepoint: 24 weeks
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Inter-investigator comparison of Global photography evauationTimepoint: 24 weeks
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Blinded and non-blinded evaluation of global photographsTimepoint: 24 weeks
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Source(s) of Monetary Support
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Lokmanya Tilak Municipal Medical College & General Hospital
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Ethics review
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Status: Approved
Approval date: 04/01/2013
Contact:
Lokmanya Tilak Municipal Medical College and Lokmanya General Hospital Staff and Research Society
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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