Last updated: 11/07/2018 07:32:32
Dutasteride versus Placebo and Finasteride in men with Androgenetic Alopecia
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2012-28-02
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
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
CABA, Buenos Aires, Argentina, C1055AAO
Status
Study Complete
Location
GSK Investigational Site
Tanauan City, Batangas, Philippines, 4232
Status
Study Complete
Location
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
Status
Study Complete
Location
GSK Investigational Site
Viña del Mar, Valparaíso, Chile, 252 0000
Status
Study Complete
Location
GSK Investigational Site
La Boca, Buenos Aires, Argentina, C1155AHD
Status
Study Complete
Location
GSK Investigational Site
Naucalpan, Estado de México, Mexico, 11200
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7580206
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425BEA
Status
Study Complete
Location
GSK Investigational Site
Mazatlan, Sinaloa, Sinaloa, Mexico, 82126
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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.
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