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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 MT

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

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

Page last updated: August 23, 2015

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