Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Androgenetic Alopecia
Intervention: 1mg Finasteride active (Drug); 0.02mg dutasteride (Drug); 0.1mg dutasteride (Drug); 0.5mg dutasteride (Drug); Finasteride placebo (Drug); Dutasteride placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: 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 MTChange 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 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 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 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 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 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 Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately 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) 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 Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26) Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26) Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24 Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24
Detailed description:
Androgenetic alopecia is a common, androgen-induced, pattern of progressive loss of scalp
hair with an onset at any age after puberty in genetically predisposed people. The
influence of androgens on scalp hair growth is mediated by local and systemic conversion of
testosterone to dihydrotestosterone , by the enzyme 5 alpha-reductase. 5 alpha-reductase
has been shown to exist as 2 isoenzyme forms, Type 1 and Type 2. Type 1 is predominantly
located in the skin, both in the hair follicles and sebaceous glands, and is also found in
the liver and kidney . Type 2 is the dominant form in male genitalia, including the
prostate, although it has also been reported to be present in the inner root sheath of the
hair follicle. The presence of both isoenzymes in the hair follicles suggests that both
forms are likely to be important in the pathogenesis and treatment of androgenetic alopecia.
Inhibition of both Type 1 and Type 2 5 alpha-reductase may be expected to more effectively
reduce systemic and local dihydrotestosterone levels than inhibition of either isoenzyme
alone.
Finasteride is a selective Type 2 5 alpha-reductase inhibitor that is currently the only
approved oral treatment for androgenetic alopecia worldwide. Dutasteride inhibits both Type
1 and Type 2 5alpha-reductase and is approved in more than 80 countries for the treatment of
benign prostatic hyperplasia, and in Korea for the treatment of hair loss. Dutasteride is
approximately 3 times as potent as finasteride at inhibiting Type 2 5 alpha-reductase and
more than 100 times as potent at inhibiting Type 1 5 alpha-reductase.
In a Phase II double-blind, placebo-controlled clinical study (ARIA2004) conducted in the
United States, dutasteride demonstrated significant increases in target area hair count, as
compared with placebo, as early as 12 weeks. In a Phase III double- blind,
placebo-controlled clinical study conducted in Korea, dutasteride 0. 5 milligram (mg)
demonstrated significant increases in target area hair count, as compared with placebo, at
24 weeks. This 6 month study is being conducted to provide additional evidence of the
efficacy and safety of three doses of dutasteride (0. 02, 0. 1 and 0. 5mg) in the treatment of
androgenetic alopecia, and more specifically, to characterize the dose-response relationship
in an ethnically-diverse population. Treatment arms will be equally balanced with
approximately 180 per arm.
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Male.
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
Locations and Contacts
GSK Investigational Site, Buenos Aires 1425, Argentina
GSK Investigational Site, Buenos Aires C1114AAP, Argentina
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, Mexico City 03720, Mexico
GSK Investigational Site, Mexico city 06780, Mexico
GSK Investigational Site, Lima Cercado LIMA 01, Peru
GSK Investigational Site, Lima Lima 27, 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, Russian Federation
GSK Investigational Site, Nizhny Novgorod 603950, Russian Federation
GSK Investigational Site, Ryazan 390046, Russian Federation
GSK Investigational Site, St'Petersburg 192102, Russian Federation
GSK Investigational Site, St-Petersburg 196084, Russian Federation
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
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, Naucalpan, Estado de México 11200, Mexico
GSK Investigational Site, Zapopan, Jalisco, Jalisco 45190, Mexico
GSK Investigational Site, Lima 41, Lima Lima 41, Peru
GSK Investigational Site, Monterrey, Nuevo León 64460, Mexico
GSK Investigational Site, Santiago, Región Metro De Santiago 7580206, Chile
GSK Investigational Site, Mazatlan, Sinaloa, Sinaloa 82126, Mexico
GSK Investigational Site, Viña del Mar, Valparaíso 252 0000, Chile
Additional Information
Starting date: October 2010
Last updated: August 29, 2013
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