Botox turns 20: Safety, efficacy unparalleled - but competition lurks

May 1, 2009

Nearly two decades after the introduction of botulinum toxin A for therapeutic indications, Botox Cosmetic (botulinum toxin A, Allergan) ranks among the safest and most successful æsthetic treatments available, dermatologists say. But, because of its relatively high cost, doctors say they would welcome competitive botulinum toxin options.

Key Points

National report - Nearly two decades after the introduction of botulinum toxin A for therapeutic indications, Botox Cosmetic (botulinum toxin A, Allergan) ranks among the safest and most successful aesthetic treatments available, dermatologists say. But, because of its relatively high cost, doctors say they would welcome competitive botulinum toxin options.

Botox originally earned Food and Drug Administration (FDA) approval for treating blepharoplasty and strabismus in December 1989. It was approved to treat cervical dystonia in 2000 and primary axillary hyperhydrosis in 2004.

Approved for glabellar lines - its only cosmetic indication to date - in 2002, Botox Cosmetic ranks among the favorite and most frequently used treatments of all dermatologists interviewed by Dermatology Times.

For patients, Botox Cosmetic provides "a lot of gain without much pain," says Judith Hellman, M.D., a New York dermatologist in private practice and assistant clinical professor of dermatology, Mount Sinai School of Medicine, New York.

Thanks to Botox, lasers and fillers, "There's been a major revolution in the field of rejuvenation, which now is much more nonsurgical. It's able to spare people from extensive downtime and surgical risk," she says.

Ross Kaplan, M.D., finds Botox to be predictable, with a minimal side effect profile. "And it makes many of my patients very happy with what I can do for a very small expenditure," he says.

Dr. Kaplan is medical director of Camarillo, Calif., Coastal Dermatology Medical and Cosmetic Center.

"I use Botox almost daily," says Gennady Rubinstein, M.D., clinical instructor, department of medicine (dermatology), University of California, Los Angeles, and director, Dermatology and Laser Center of Studio City.

Botox: How do competitors compare?

"I find it to be one of the most important cosmetic dermatology treatments in my arsenal," Dr. Rubinstein says. "It's probably the most common procedure performed in my office."

Indications

Along with strabismus and blepharospasm, Botox's therapeutic indications currently include severe primary axillary hyperhidrosis and cervical dystonia, according to Allergan.

In the United States, the neurotoxin is also being investigated for conditions including chronic migraines, overactive bladder and post-stroke spasticity, according to the company's Web site.

Botox Cosmetic's only FDA-approved indication is for "temporary improvement in the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity" in patients ages 65 or younger, the product's package insert states.

However, doctors say they also use Botox Cosmetic off-label in other upper-face locations, such as crows' feet, and, occasionally, in the lips, depressor anguli oris, mentalis and platysmal bands.

In addition to Botox's short-term effects, Dr. Rubinstein says, "One thing I talk about with patients nowadays is how patients who have been steadily using Botox for many years are able to prevent wrinkling and reverse the process of aging, to some extent."

People may not have prominent wrinkles yet, "but it's important for them to realize that Botox has that effect - to prevent aging, as well," he says.