This is news to me. Something has changed suddenly. I can’t wait to see the data. I’m starting a topical duta this week.
Dutasteride in Phase 3 clinical trials for hair loss
Posted on March 7th, 2007 in FDA News, Hair Loss News by admin | 1,347 Views |
GlaxoSmithKline is currently conducting clinical trials for Dutasteride, otherwise known as Avodart, as a treatment for male pattern baldness (MPB).
Dutasteride had been on track for FDA submission as a treatment for Androgenetic Alopecia, but in 2003 Glaxo pulled the plug on their Phase 3 hair loss trials, much to the dismay of many hair loss sufferers worldwide.
Internet rumors persisted for a long time about the reason why Glaxo pulled the plug, but with the release of Avodart as a treatment for Benign Prostatic Hyperplasia (BPH), the drug became readily available to anyone who could obtain a prescription. Since then many men have taken the drug as a hair loss treatment with mixed results. Some men have claimed to have excellent results, while others have complained about increased hair shedding.
The true efficacy will soon be known as it now appears something has changed at Glaxo and the trial is back on. GlaxoSmithKline have set up a Phase 3 clinical study in Korea as part of the process to seek FDA approval for using Dutasteride as a treatment for male pattern hairloss.
A clinical study is being conducted in Korea and is enrolling men of the ages 18 - 49 to test the efficacy of Dutasteride in stimulating hair growth.
Men with a hair loss pattern classified as type IIIv, IV, or V on the modified Norwood-Hamilton classification are eligible to apply, but men who are a type IVa or Va are excluded from the trial.
Other exclusions from the trial include men who:
• Have global scalp hair thinning, including occipital areas
• Have 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.
• Use hair colorants/hair dyes, or have the remaining traces of colorants in their hair.
• Have used finasteride (Propecia) or other 5 AR inhibitors within the 12 months prior to screening.
• Have previously use of dutasteride.
• Have used phytotherapy (e.g. saw palmetto) within 8 weeks prior to screening.
Or have used any of the following drugs 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
The expected total enrollment in this trial is 150 subjects and they will be using 0.5mg of Dutasteride taken daily.
It’s very unlikely that this is the only trial because typically drug trials are done at multiple locations to ensure accuracy. It could either be a pilot trial or Glaxo could possibly be in the midst of setting up more trials at different centers.