Last updated: 11/07/2018 07:32:32

Dutasteride versus Placebo and Finasteride in men with Androgenetic Alopecia

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GSK study ID
114263
See study documents
Clinicaltrials.gov ID
NCT01231607
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

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)

Timeframe: Baseline and Week 24

Secondary outcomes:

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Baseline, Week 12, and Week 24

Change from Baseline in terminal hair count (THC) within a 2.54 cm (1 inch) diameter circle at the vertex at Week 12 and Week 24, as assessed by MT

Timeframe: Baseline, Week 12, and Week 24

Change from Baseline in terminal hair count within a 1.13 cm (0.44 inch) diameter circle at the vertex at Week 12 and Week 24, as assessed by MT

Timeframe: Baseline, Week 12, and Week 24

Global assessment of improvement from Baseline to Week 24 assessed for vertex and frontal views separately

Timeframe: Baseline and Week 24

Change from Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) scores assessed at Week 12 for vertex and frontal views separately

Timeframe: Baseline and Week 12

Change from Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) scores assessed at Week 24 for vertex and frontal views separately

Timeframe: Baseline and Week 24

Number of participants with the indicated change from Baseline (BL) in the stage (S) of androgenic alopecia (AGA) according to the Norwood-Hamilton scale at Week 12 (W12)

Timeframe: Baseline and Week 12

Number of participants with the indicated change from Baseline (BL) in the stage (S) of androgenic alopecia (AGA) according to the Norwood-Hamilton scale at Week 24

Timeframe: Baseline and Week 24

Serum concentration of dutasteride at Week 12, Week 24, and follow-up (Week 26)

Timeframe: Week 12, Week 24, and Week 26

Serum dihydrotestosterone (DHT) at Week 12, Week 24, and follow-up (Week 26)

Timeframe: Week 12, Week 24, and Week 26

Change from Baseline in hair growth index (HGI) scores at Weeks 12 and 24

Timeframe: Baseline, Week 12, and Week 24

Change from Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24

Timeframe: Baseline, Week 12, and Week 24

Interventions:
  • Drug: 1mg Finasteride active
  • Drug: 0.02mg dutasteride
  • Drug: 0.1mg dutasteride
  • Drug: 0.5mg dutasteride
  • Drug: Finasteride placebo
  • Drug: Dutasteride placebo
    • Enrollment:
    917
    Primary completion date:
    2012-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Walter Gubelin Harcha, Tsen-Fang Tsai, Kensei Katsuoka, Makoto Kawashima, Ryoji Tsuboi, Allison Barnes, Dushen Chetty, Geraldine Ferron-Brady, Julia Maria Barboza Martinez.A randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride in the treatment of male subjects with androgenetic alopecia.J Am Acad Dermatol.2014;Volume 70(Issue 3):489–498.e3
    Medical condition
    Androgenetic alopecia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    October 2010 to February 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Male
    Age
    20 - 50 years
    Accepts healthy volunteers
    No
    • Norwood-Hamilton Type III vertex, IV, or V
    • History or evidence of hair loss other than androgenetic alopecia
    • Scarring of the scalp
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Norwood-Hamilton Type III vertex, IV, or V
    Exclusion criteria:
    • 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Buenos Aires, Buenos Aires, Argentina, 1425
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    CABA, Buenos Aires, Argentina, C1055AAO
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tanauan City, Batangas, Philippines, 4232
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lima, Lima, Peru, Lima 27
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Patumwan Bangkok, Thailand, 10330
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Rajthevee Bangkok, Thailand, 10400
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 37 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2012-28-02
    Actual study completion date
    2012-28-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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