Update:
This trial is from pre-2005 and is no longer recruiting. We never received updated information on it, past what you read below.
Last month we announced a new drug being studied for hair loss by Bristol Myers which promises to be a thousand times more potent at performing the active mechanism (as a potassium channel opener) than Minoxidil. Today we have an update…Original story: Hair Treatment Clinical Trial Wants You.
Unfortunately due to a confidentiality agreement imposed by the conductors of this study, Bristol Myers-Squibb, even the lead dermatologist in La Jolla California was unable to give us much information on the specifics. Nevertheless, in the past month, we have had nearly 200 people register to participate in the study, and through some of them we’ve been given more insight as to what this study entails.
Here is a letter from one of our users regarding his experience at the local research branch office he was directed to. His anonymity will be maintained for obvious reasons:
“Dear HairlossTalk, I recently spoke to a few of the dermatologists involved in the Bristol Myers study and was wondering if you could help clarify a couple of things. The first problem is that I may not qualify, as I have diffuse thinning all over the scalp, similar to female pattern baldness, rather than the recession and bald vertex that characterizes MPB. (the study requires men who are receding). The doctor, that I spoke to at the Cleveland, Ohio site stated that I might not qualify because they are looking for Norwood 3-4. However, the coordinator at the Michigan site said that I might qualify with diffuse thinning but that it was impossible to tell over the phone and that I would have to go down for a screening. Secondly, even if I qualify, I understand that I only have a 50% chance of actually getting the BM drug. [They are conducting the study with] 25% [of people on] Rogaine 5% and 25% [of people on] placebo. The thing that bothers me the most is that they said they are shaving an area of the vertex. One doctor said that the area will be the size of a quarter and another said that it would be a little larger than the size of a dime. I might be able to deal with a dime-sized bald spot. They said that these are phase II trials therefore they’ve completed phase I on animals (I’ve heard stump tailed macaques) and that they are looking for early baldness. I really appreciate your taking the time to read this. Your help means a lot.
I will get more information on the Bristol Myers study and keep you updated. The Michigan and Cleveland sites both have stated that they have no idea what the drug is and Bristol Myers intends to keep it that way. The sites will be given precisely the amount of drug needed for the study, not a drop more, and will have to return the empty bottles etc. and follow very strict protocol. Apparently, the drug is a “cream” rather than an alcoholic solution. The idea of shaving a portion of my vertex is quite bothersome but I think it’s written in stone. As I said, I’ll get some more info and keep you posted.”
We forwarded the above email to our representative in the La Jolla office, and received the following reply:
“I am the dermatologist in the San Diego area conducting the study along with other physicians in various parts of the U.S. I must admit that your description of your hair loss pattern makes it less likely that you would qualify for the study. It is not that Bristol Myers is not interested in your problem, only that such studies are designed with fairly rigid criteria to allow the greatest possible chance of succes for the drug. Eliminating variables make this easier. As far as the head shaving goes, the study uses hair counts as a measure of efficacy (still the best measure we have). These are done with careful macro photography of the scalp then digitization of the image for consistent counting. The photos are taken with carefully designed macrophotography devices that take a close up photo of ~12 mm of the scalp (they take 12 mm to get 10 mm readable). To get the photograph, the hairs in the area are clipped (not really shaved but it’s semantics) to a length of ~1 mm. The area to be clipped is chosen by the doctor as a site of “active” hair loss (usually the front edge of the balding area on the vertex or crown). The area can often (but not always) be covered by existing hair (depending upon hairstyle). With regard to question #4; the phase I studies are primarily safety studies with only one efficacy trial that I know of. I do not expect this medication to be “really amazing at regrowing hair” but more likely that it is substantially better than the existing topical product, minoxidil. Thanks for your interest.”
