Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
A Study of the Efficacy and Safety of Multiple Doses of Dutasteride Versus Placebo and Finasteride in the Treatment of Male Subjects With Androgenetic Alopecia
1 other identifier
interventional
917
9 countries
39
Brief Summary
The purpose of this six month study is to show that dutasteride is safe and more effective than placebo, and at least as safe and effective as finasteride in treating hair loss in men with androgenetic alopecia. Three doses of dutasteride will be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2010
Shorter than P25 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2010
CompletedStudy Start
First participant enrolled
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2012
CompletedResults Posted
Study results publicly available
October 4, 2012
CompletedAugust 10, 2018
June 1, 2018
1.3 years
October 28, 2010
August 30, 2012
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)
The primary target area HC was based on the nonvellus hair (\>=30 micrometers \[μm\] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.
Baseline and Week 24
Secondary Outcomes (16)
Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT
Baseline and Week 24
Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT
Baseline and Week 12
Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12
Baseline and Week 12
Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT
Baseline, Week 12, and Week 24
Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT
Baseline, Week 12, and Week 24
- +11 more secondary outcomes
Study Arms (5)
1mg Finasteride
ACTIVE COMPARATOR1mg finasteride active plus dutasteride placebo, by mouth once daily
0.02mg Dutasteride
ACTIVE COMPARATOR0.02mg dutasteride active plus finasteride placebo, by mouth once daily
0.1mg Dutasteride
ACTIVE COMPARATOR0.1mg dutasteride active plus finasteride placebo, by mouth once daily
0.5mg Dutasteride
ACTIVE COMPARATOR0.5mg dutasteride active plus finasteride placebo, by mouth once daily
Placebo
PLACEBO COMPARATOR1mg finasteride placebo plus dutasteride placebo, by mouth once daily
Interventions
finasteride placebo, by mouth once daily
Eligibility Criteria
You may qualify if:
- Norwood-Hamilton Type III vertex, IV, or V
You may not qualify if:
- History or evidence of hair loss other than androgenetic alopecia
- Scarring of the scalp
- Use of dutasteride in previous 18 months
- Use of finasteride within previous 12 months
- Hair transplantation or hair weaving within 6 months
- Use of Minoxidil within previous 6 months
- Use of drugs with anti-androgenetic/androgenetic properties within previous 6 months
- Use of Drugs that cause hypertrichosis or hypotrichosis within previous 6 months
- Light or laser treatment of scalp within previous 3 months
- Cosmetic products aimed at improving or correcting signs of hair loss within previous 2 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (39)
GSK Investigational Site
CABA, Buenos Aires, C1055AAO, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BEA, Argentina
GSK Investigational Site
La Boca, Buenos Aires, C1155AHD, Argentina
GSK Investigational Site
Buenos Aires, 1425, Argentina
GSK Investigational Site
Buenos Aires, C1114AAP, Argentina
GSK Investigational Site
Viña del Mar, Región de Valparaíso, 252 0000, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7580206, Chile
GSK Investigational Site
Fukuoka, 812-0025, Japan
GSK Investigational Site
Osaka, 530-0057, Japan
GSK Investigational Site
Osaka, 532-0003, Japan
GSK Investigational Site
Tokyo, 103-0028, Japan
GSK Investigational Site
Tokyo, 160-0022, Japan
GSK Investigational Site
Zapopan, Jalisco, Jalisco, 45190, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64460, Mexico
GSK Investigational Site
Mazatlan, Sinaloa, Sinaloa, 82126, Mexico
GSK Investigational Site
Naucalpan, State of Mexico, 11200, Mexico
GSK Investigational Site
Mexico City, 03720, Mexico
GSK Investigational Site
Mexico City, 06780, Mexico
GSK Investigational Site
Lima, Lima Province, Lima 41, Peru
GSK Investigational Site
Lima, Lima 27, Peru
GSK Investigational Site
Lima Cercado, LIMA 01, Peru
GSK Investigational Site
Makati City, 1200, Philippines
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Quezon City, 1113, Philippines
GSK Investigational Site
Quezon City, Philippines
GSK Investigational Site
Tanauan City, Batangas, 4232, Philippines
GSK Investigational Site
Moscow, 107076, Russia
GSK Investigational Site
Nizhny Novgorod, 603950, Russia
GSK Investigational Site
Ryazan, 390046, Russia
GSK Investigational Site
Saint Petersburg, 196084, Russia
GSK Investigational Site
St'Petersburg, 192102, Russia
GSK Investigational Site
Tainan, 70403, Taiwan
GSK Investigational Site
Taipei, 105, Taiwan
GSK Investigational Site
Taipei, 220, Taiwan
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Bangkoknoi Bangkok, 10700, Thailand
GSK Investigational Site
Chiang Mai, 50200, Thailand
GSK Investigational Site
Patumwan Bangkok, 10330, Thailand
GSK Investigational Site
Rajthevee Bangkok, 10400, Thailand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2010
First Posted
November 1, 2010
Study Start
October 28, 2010
Primary Completion
February 1, 2012
Study Completion
February 28, 2012
Last Updated
August 10, 2018
Results First Posted
October 4, 2012
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.