I’m 25 years old from Israel and I’m a big fan of your website and very impressed by the elaborate answers you give. As part of my research of treating my own hair loss, I read a lot about dutasteride (Avodart) and ran into this clinical trial.
It looks like GSK is doing the last phase before taking it out to the market as a hair loss product. What is your opinion about this study:
Thank you for bringing this to our attention. I really don’t have anything to add, as this Phase IV study just started in April and isn’t scheduled to end until 2013. There’s not much info available beyond what is listed on that summary page.
The US ClinicalTrials.gov glossary describes the four phases of clinical trials: “Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.”
The glossary further defines Phase IV as: “Post-marketing studies to delineate additional information including the drug’s risks, benefits, and optimal use.”
So while Phase IV trials are generally done after the drug is already approved by the FDA (at least in the US), perhaps things are different with the phases outlined by the Korea FDA. Searching the Korea FDA site isn’t proving too helpful. I do know that Avodart (dutasteride) isn’t approved for treating hair loss yet in the US, though. Any readers out there with some knowledge about the various clinical trial phases and how they might different by country, please feel free to set me straight in the comments section.