Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

NCT ID: NCT01231607

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 917 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-28
• Study Completion Date: 2012-02-28

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.

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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1mg Finasteride

1mg finasteride active plus dutasteride placebo, by mouth once daily

Group Type: ACTIVE_COMPARATOR

1mg Finasteride active

Intervention Type: DRUG

1mg finasteride active, by mouth once daily

Dutasteride placebo

Intervention Type: DRUG

dutasteride placebo, by mouth once daily

0.02mg Dutasteride

0.02mg dutasteride active plus finasteride placebo, by mouth once daily

Group Type: ACTIVE_COMPARATOR

0.02mg dutasteride

Intervention Type: DRUG

0.02mg dutasteride active, by mouth once daily

Finasteride placebo

Intervention Type: DRUG

finasteride placebo, by mouth once daily

0.1mg Dutasteride

0.1mg dutasteride active plus finasteride placebo, by mouth once daily

Group Type: ACTIVE_COMPARATOR

0.1mg dutasteride

Intervention Type: DRUG

0.1mg dutasteride active, by mouth once daily

Finasteride placebo

Intervention Type: DRUG

finasteride placebo, by mouth once daily

0.5mg Dutasteride

0.5mg dutasteride active plus finasteride placebo, by mouth once daily

Group Type: ACTIVE_COMPARATOR

0.5mg dutasteride

Intervention Type: DRUG

0.5mg dutasteride active, by mouth once daily

Finasteride placebo

Intervention Type: DRUG

finasteride placebo, by mouth once daily

Placebo

1mg finasteride placebo plus dutasteride placebo, by mouth once daily

Group Type: PLACEBO_COMPARATOR

Finasteride placebo

Intervention Type: DRUG

finasteride placebo, by mouth once daily

Dutasteride placebo

Intervention Type: DRUG

dutasteride placebo, by mouth once daily

Interventions

1mg Finasteride active

1mg finasteride active, by mouth once daily

Intervention Type: DRUG

0.02mg dutasteride

0.02mg dutasteride active, by mouth once daily

Intervention Type: DRUG

0.1mg dutasteride

0.1mg dutasteride active, by mouth once daily

Intervention Type: DRUG

0.5mg dutasteride

0.5mg dutasteride active, by mouth once daily

Intervention Type: DRUG

Finasteride placebo

finasteride placebo, by mouth once daily

Intervention Type: DRUG

Dutasteride placebo

dutasteride placebo, by mouth once daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

CABA, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

La Boca, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Zapopan, Jalisco, Jalisco, Mexico

GSK Investigational Site

Monterrey, Nuevo León, Mexico

GSK Investigational Site

Mazatlan, Sinaloa, Sinaloa, Mexico

GSK Investigational Site

Naucalpan, State of Mexico, Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Lima Cercado, , Peru

GSK Investigational Site

Makati City, , Philippines

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Tanauan City, Batangas, , Philippines

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Nizhny Novgorod, , Russia

GSK Investigational Site

Ryazan, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

St'Petersburg, , Russia

GSK Investigational Site

Tainan City, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Bangkoknoi Bangkok, , Thailand

GSK Investigational Site

Chiang Mai, , Thailand

GSK Investigational Site

Patumwan Bangkok, , Thailand

GSK Investigational Site

Rajthevee Bangkok, , Thailand

Countries

Argentina; Chile; Japan; Mexico; Peru; Philippines; Russia; Taiwan; Thailand

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

114263

Identifier Type: -

Identifier Source: org_study_id