By Linda Marsa
Times Staff Writer

Now that Botox has received U.S. approved as an anti-wrinkle treatment, doctors already are warning that an expected promotional blitz will likely send many image-conscious Americans flocking for treatment to inexperienced health professionals, resulting in potentially dangerous complications.

Approval by the Food and Drug Administration will give consumers more confidence about the safety of the procedure, doctors said, and the product's manufacturer, Irvine based Allergan, has announced plans for a $50-million advertising campaign to raise awareness and boost sales. Moreover, experts anticipate a flurry of advertising and fierce price competition among dermatologists and other doctors, similar to the laser eye-surgery boom that began in the mid-1990s.

"This will convince a lot of people who've never touched (Botox) before that it's OK to use," said Dr. Richard G Glogau, a clinical professor of dermatology at UC San Francisco, who has used botulinum toxin type A, or Botox, in his practice for eight years. "But we're going to see all sorts of strange aesthetic outcomes when these procedures are performed by physicians who haven't done them before."

People tend to think New Yorkers are bold and independent. The sad truth is that most of us are like poor little lab mice in a maze ruled by some diabolical scientist who stimulates our desire sensors over and over again, keeping us in a permanent state of debilitating stuff-lust: You've just recovered from seeing the world's most beautiful bias-cut Vera Wang evening dress in the window of Bergdorf's and are beginning to think about higher things again when you pass a furniture showroom and the sight of an elegant Eames late-50's table hits you over the head like a sledgehammer. Over time, I've made what I think is a pretty healthy adaptation: I've become an ace bargain-hunter. Still, after about ten years spent honing my craft, I'm running out of closet space and entering a time when one realizes that all the clothes in the world won't make you look good if, say, that big clot of broken capillaries around your nose refuses to be covered by the most industrial strength concealer. A problem I didn't think I could bargain hunt away: Cosmetic procedures are the very things we're told we must never bargain over. We've all read the cautionary tales and seen the grisly pictures. So, I had almost resigned myself to paying ... choke, wince... retail.

The time aspect is one drawback. A lot of the studies require a year's follow up to notice the duration of the side effects. Checkup appointments are made well in advance when you sign the consent forms, so taking a spontaneous round the world cruise is going to be a problem, because the visit can be shifted only a day or so in either direction. Additionally, certain clinical trials ask that patients not seek other forms of treatment that could muddy the results, says Richard Glogau, MD, a San Francisco dermatologist who does a lot of testing. The protocols that delineate these rules are written by the person or persons ordering the study, be they a single doctor or a large pharmaceutical company. Protocols can forbid additional treatments such as microdermabrasion, Retin-A, and Kinerase cream, even if they're the only thing saving a patient from a face full of acne or fine lines. Sudden weight gain or loss can have a dramatic effect on the skin, so someone planning to drop fifty pounds would not be selected for participation. "Weight gain and loss is generally tolerable within the 10 to 15 percent range," Glogau says. A subject's sex is not considered a significant variable, so studies usually take both men and women.

Still, by nature clinical trials involve uncertainty. To protect themselves, bargain hunters should ask the trial coordinator if the study has been approved by an IRB. The IRB is also charged with approving consent forms, so their seal should be on all the forms given out before the trial starts. Potential guinea pigs could also ask the doctor to see the actual paperwork - and there is plenty - that has passed between them and the IRB. Doctors involved in clinical trials are usually well known. Their credentials can be checked with the American Board of Medical Specialties.