Dutasteride in Phase III Trials

[JohnS]

Not sure you guys were aware of this but, after being pulled after Phase II trials, GSK has decided to go forward into Phase III and bring this finally to market as a hair loss drug. Here the info:

 

A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia

 

This study is currently recruiting patients.

Verified by GlaxoSmithKline February 2007

 

Sponsored by: GlaxoSmithKline

Information provided by: GlaxoSmithKline

Identifier: NCT00441116

 

Purpose

The aim of this Phase III study is to compare the efficacy, safety and tolerability of dutasteride (0.5mg) with placebo for 6 months, in Korean male subjects with androgenetic alopecia in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification. Condition Intervention Phase

Androgenetic Alopecia

Drug: Dutasteride 0.5mg oral tablets

Phase III

 

MedlinePlus related topics: Hair Diseases and Hair Loss

Genetics Home Reference related topics: Hair Diseases and Hair Loss

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: An Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Dutasteride 0.5mg Once Daily for 6 Months in the Treatment of Male Subjects With Androgenetic Alopecia (Norwood-Hamilton Classification Type IIIv, IV and V)

Further study details as provided by GlaxoSmithKline:Primary Outcomes: Hair growth assessed by macrophotographic technique (hair count) in the vertex at 6 months.

Secondary Outcomes: Subject assessment of change in hair growth and loss. Panel and investigator photographic assessment of change in hair growth Hormone measurements of LH at screening and DHT, testosterone, TSH, and T4. Assessment of sexual function

Expected Total Enrollment: 150 Study start: December 2006

 

Eligibility

Ages Eligible for Study: 18 Years - 49 Years, Genders Eligible for Study: Male CriteriaInclusion criteria:

 

Diagnosis of Male Pattern Hair Loss classified as type IIIv, IV, or V utilising the modified Norwood-Hamilton classification (N.B. types IVa and Va are excluded)

Exclusion criteria:

 

Global scalp hair thinning, including occipital areas

Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving.

Subjects who use hair colourants/hair dyes, or have the remaining traces of colourants in their hair.

Use of finasteride or other 5 AR inhibitors within the 12 months prior to screening.

Previous use of dutasteride.

Use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to screening.

Use of the following during the 6 months prior to screening:

 

Minoxidil (oral or topical)

Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.

Topical estrogen, progesterone

Tamoxifen

Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens)

Anabolic steroids

Lithium and phenothiazines

Location and Contact Information

 

 

Korea, Republic of

GSK Clinical Trials Call Center, Seoul, 110-744, Korea, Republic of; Recruiting

GSK Clinical Trials Call Center 1-877-379-3718 oskwon@snu.ac.kr

 

 

GSK Clinical Trials Call Center, Seoul, 140-702, Korea, Republic of; Not yet recruiting

GSK Clinical Trials Call Center 1-877-379-3718 drro@netsgo.com

 

 

GSK Clinical Trials Call Center, Seoul, 134-090, Korea, Republic of; Recruiting

GSK Clinical Trials Call Center 1-877-379-3718 sim@khnmc.or.kr

 

 

GSK Clinical Trials Call Center, Wonju, 220-701, Korea, Republic of; Recruiting

GSK Clinical Trials Call Center 1-877-379-3718 leews@wonju.yonsei.ac.kr

 

Study chairs or principal investigators

GSK Clinical Trials, M.D., Ph.D., Study Director, GlaxoSmithKline More Information

Study ID Numbers: 106377

Last Updated: February 27, 2007

Record first received: February 27, 2007

 

Health Authority: Korea: Food and Drug Administration

[HK500]

Thanks for this John, it will be fascinating to hear the conclusion of the study. Please keep us posted if you can find a way to follow this up.

[hairbank]

Great.............I'll be anxious to see the end result and how quickly they try to market this.

[Bill - Seemiller]

JohnS,

 

thanks for the information. For some reason I thought I read that they were not going to proceed with testing...I can't remember any details on that...just remember reading it. I am, however, glad they are proceeding. I look forward to the details and results of the study.

 

Bill