Experts Speak
BOTOX
BOTOX GETS FDA NOD FOR TREATING GLABELLAR LINES
According to statistics from the American Society for Dermatologic Surgery, liposuction surgery
With the Food and Drug Administration's approval of botulinum toxim A for cosmetic use, dermatology would appear to have it's Viagra - a drug that is likely to have blockbuster sales and prompt cocktail party conversations and the late-nite talk show host jokes.
The FDA's April 15 approval of botulinum toxin A (Botox) for the treatment of glabellar lines was based on a multicenter, double-blind, placebo-controlled study of 535 patients whose lines were assessed at baseline and at different points up to 4 months after treatment with 20 unites of Botox injected into the procerus and corrugator muscles.
The study reported that the maximum response rate occurred at day 30 after treatment. At day 30, 80% of 405 subjects in the active treatment arm had a reduction in the severity of their glabellar lines at maximum frown, from moderate or severe at baseline to mild or none, according to blinded investigator assessment.
That compared with 3% of 130 subjects in the study's placebo arm.
Eighty nine percent of the treated subjects reported that they thought they had a significant improvement in their glabellar wrinkles, compared with 7% of those who received placebo.
Many dermatologist who regularly perform Botox injection greeted the approval with enthusiuasm and predicted that it will only further increase the popularity of this procedure, already the most prformed in the United States.
"This is all to the good," said Dr. Alastair Carruthers of Vancouver, B.C., the first physician to use botulinum toxiz A to treat frown lines and a prime mover in promoting its use. Botox popularity "is going to do nothing but go up. There are still a lot of people worried at the "P" words - paralysis and poison- and this will allay some of those fears. We're still a long way from reaching [market] saturation."
Dr. Carruthers predicted that the approval will help to proote responsible use. Approval frees the company, Allergan Inc., to dispense information and have greater cfontrol of the marketplace.
Specifically noting the Botox parties and events that are becoming popular in places like Los Angeles, where groups of people get together for injection over cockaits or lunch, Dr. Carruthers said the company sponsored promotion is likely to help change the perception that Botox is something to be done "with the amount of thought you put into having a glass of wine" toward one that acknowledges that the injections are a surgical procedure.
"This is the premier cosmetic product in the world at this time, and it will be in the company's interest to see that this is not trivialized," said Dr. Carruthers, who serves as a paid consultant to Allergan.
No one interviewed for this article had any criticism of the FDA's action, but critics of cosmetic dermatology said that they approval is a symbol of further erosion of the integrity of dermatology as a profession dedicated to services to patients with disease.
"Anything that takes American Dermatology further away from dealing with disease is not in the best ineterst of dermatology," said Dr. A Bernard Ackerman of New York City. "The issue of Botox is fundamentally about lucre. If this pervasive trend continues, it is inevitable that one day dermatologist will be competing against barbers for haircuts and, in the endevor, seeking to attract "customer" by proclaiming "We know more about keratin."
Liposuction Safety
According to statistics from the American Society for Dermatologic Surgery, liposuction surgery performed as a solo procedure under local tumescent anesthesia in an outpatient setting carries an exceptionally high safety record. The tumescent technique involves injecting solution made up of local anesthetic and adrenalin (to reduce blood loss) into the areas to be suctioned. This also speeds recovery time and reduces discomfort for the patient. Moreover, the society's findings confirm that the primary predictor of complication after liposuction is the use of general anesthesia.
"We are very encouraged by these data because they support not only the highest standard of patient care, but also the safety of surgical procedures that was as dermatologists routinely perform under local anesthesia in our offices," says dermatologic surgeon Brett Coldiron, MD.
New research demonstrates that office-based procedures are generally safe that that no surgical complication appear to be specifically related to the office setting
Based on a review of incident reports in Florida, Dr. Coldiron discovered that there were actually no deaths associated with office procedures using local anesthesia, regional block anesthesia, or intravenous sedation.
Data collected by the Florida Agency for Health Care Administration in 2000 indicated 31 procedure-related complication or deaths involving 28 physicians. Six deaths were reported, and of those, three patients had undergone liposuction using general anesthesia.
Source: American Society for Dermatologic Surgery "Healthy Skin & Hair" Spring 2002:pp 5
Vitamin C and Vehicle for Rejuvenation of Photodamage
BACKGROUND. Aging of the population, in particular the "baby boomers," has resulted in increased interest in methods of reversal of photodamage. Non-invasive treatments are in high demand, and our knowledge of mechanisms of photodamage to skin, protection of the skin, and repair of photodamage are becoming more sophisticated and complex.
OBJECTIVE. The objective of this study is to determine if the topical use of a vitamin C preparation can stimulate the skin to repair photodamage and result in clinically visible differences, as well as microscopically visible improvement.
METHODS. Ten patients applied in a double-blind manner a newly formulated vitamin C complex having 10% ascorbic acid (water soluble) and 7% tetrahexyldecyl ascorbate (liquid soluble) in an anhydrous polysilicone gel base to one-half of the face and the inactive polysilicone gel base to the opposite side. Clinical evaluation of wrinkling, pigmentation, inflammation, and hydration was performed prior to the study and at weeks 4, 8, and 12. Two mm punch biopsies of the lateral cheeks were performed at 12 weeks in four patients and stained with hematoxylin and eosin, as well as in situ hybridization studies using an anti-sense probe for mRNA for typeI collagen. A questionnaire was also completed by each patient.
RESULTS. A statistically significant improvement of the vitamin C-treated side was seen I the decreased photoaging scores of the cheeks (P = 0.0006) and the peri-oral area (P = 0.01). The peri-orbital area improved bilaterally, probably indicating improved hydration. The overall facial improvement of the vitamin C side was statistically significant (P = 0.01). Biopsies showed increased Grenz zone collagen, as well as increased staining for mRNA for type I collagen. No patients were found to have any evidence of inflammation. Hydration was improved bilaterally. Four patients felt that the vitamin C-treated side improved unilaterally. No patient felt the placebo side showed unilateral improvement.
CONCLUSION. This formulation of vitamin C results in clinically visible and statistically significant improvement in wrinkling when used topically for 12 weeks. This clinical improvement correlates with biopsy evidence of new collagen formation.
Source: American Soceity for Dermatologic Surgery, Inc: Blackwell Publishing, Inc. Dermatol Surg 2002;28:231-236
