Blepharospasm

New York -- Jean Carruthers, M.D., thinks it might be appropriate for her and her dermatologist husband, Alastair, to change their middle names to "determination."

The "d" word as she terms it, is what it has taken to not only get botulinum toxin type A (Botox[R], Allergan) accepted by the medical community, but to make it one of the most frequently performed cosmetic procedures in the world.

And the Carruthers now have a 15-year retrospective study to prove the drug's safety--an aspect often cited as a patient concern. The study coincides with Botox's 15th anniversary. The Carruthers couldn't be happier that a drug they have believed in for many years and that has been in existence as a compound since 1979 now has the safety data to back its cosmetic use.

The Carruthers are credited with being the pioneers of the cosmetic application of botulinum toxin type A, which was initially cleared by the U.S. Food and Drug Administration (FDA) in 1989 for treatment of blepharospasm and strabismus, and approved in 2000 for treatment of abnormal head position and neck pain associated with cervical dystonia. In 2002, Botox was approved under the name of Botox Cosmetic for treatment of glabellar lines between the brows. Its latest approval, granted in July, was for hyperhidrosis.

Alastair Carruthers is affiliated with the department of dermatology, University of British Columbia, Vancouver; Jean with the university's department of ophthalmology. They have a private practice, the Carruthers Dermatology Centre, in Vancouver.

The study

The study, Long-Term Safety Review of Subjects Treated with Botulinum Toxin Type A for Cosmetic Use, was presented at the recently concluded American Academy of Dermatology Academy '04 meeting in New York.

The study shows Botox is safe and well-tolerated for facial cosmetic procedures when used in multiple treatment sessions over an extended period of time, and when administered by a qualified and trained healthcare professional.

According to Alastair, looking back, the current study's positive results have been long-awaited.

"Getting accepted has been frustrating for so long," he tells Cosmetic Surgery Times. "We could see the potential, we knew it was a winner, but no one was listening to us."

"They were frightened," Jean continues. "There was an article published in 1969 that called botulinum type A 'the most poisonous poison.' That stuck in the consciousness of a lot of people. It had to overcome that reputation.

"Even though its use started in ophthalmology, it was dermatologists who had the open minds to accept it as a really interesting new treatment," Jean says. "It is a privilege to be able to present our retrospective study here (at Academy '04)."

Legacy

The Carruthers describe the success of Botox as "absolutely amazing." A belief in themselves, the product and a healthy dose of tenacity fueled them.

"It was such a fringe idea in 1987; we never would've believed it would enjoy the success it's having today," Jean says. "It was quite difficult to get 30 participants to put our first study together. People would say, 'You want to inject what in my face?' We got used to disbelief. We got used to people saying, 'no thanks,' yet when you injected them and saw the results, it was so rewarding. We knew it was just a matter of keeping at it."

Still overcoming obstacles

Even though Botox has overcome many of the obstacles that it first confronted, the education battle is still not over.

"It's still overcoming the fact it's a toxin," Alastair says. "That's why we did this study. The patient questions that are being asked are principally about safety. This study can give those patients reassurance. The bogeyman that frightens people is that you're doing something that is going to rot your liver or brain and that horrendous complications will arise. We have found no evidence of any of this in our study or in other studies."

Jean says the study answers the needs of the early majority--patients who do their homework and want to see written proof of a product's efficacy.

"One thing about Botux's safety depends on injection technique," Jean explains. "A physician who is a successful injector/treater with Botox has to not only understand what it is the patient would like and be a good communicator, they have to understand what's underneath the skin and understand the way to achieve the aesthetic that the person wants."

Alastair considers over-injection of Botox to be the biggest complication.

"The worst," he says.

"There needs to be a balance," Jean explains. "With too much Botox a person crosses that invisible line between looking restored, enhanced and rejuvenated into--frankly--looking bad. That's not what you want to do."

She says physicians should use Botox with an artist's touch.

"Use it to reset the balance between muscle groups so that you stop the muscle groups that pull the face down and make it tired and desperate and draggy, and allow the upward-moving muscles to lift the brows to where they were, to soften the look.

"That is something that is so powerful," she continues. "Instead of people having facelifts surgically, especially younger people, you can get a better result with Botox, which gives people no downtime."

While the physicians agree that Botox will never eclipse surgery, they believe it can enhance, preserve and maintain a surgical facelift.

"Botox fits in extremely well with the ethos of the baby boomers--no downtime, recovery or inconvenience," Jean says.

"Botox is a choice," Alastair says. "And people need to know what their choices are. One thing is for sure. It's going to wear off, 100 percent, like it or not. If you have tried Botox, then you know how Botox works for you and when it would be appropriate for you to use it in the future."

The future

The Carruthers agree the uses for Botox are limitless.

"When used with other agents, such as fillers and intense pulsed light, Botox is an enhancement," Jean says. "It is a symbiotic relationship. One enhances the other."

Alastair agrees. "I don't think it's achieved its full potential in the home run territory, which is the frown area. People are under-dosing. We can do better with areas around the mouth and lower face."

"Penicillin was the wonder drug of the last century," Jean says. "I think Botox will be the wonder drug of this century, because there's so many different cholinergic junctions in the body that it can effect."

Botox is being looked at to help with pain, salivary gland dysfunction, posture, and spastic arms, legs and bladders, among other conditions.

"Botox will never go away," Alastair says. "Dosages may be adjusted or something else will change about it, but the knowledge that we've gained about the inside of the cell as a result of working with Botox, is here to stay."

For more information

www.botoxcosmetic.com

www.facialenhance.org

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