BBI Contributing Editor
Combining topical eflornithine hydrochloride 13.9% cream (Vaniqa) with light-based epilation is safe and enhances overall results, according to clinical studies. "Laser and light-based therapies don't seem to be particularly effective for people with light-colored hair or velus hair," observed Harvey Lui, MD, professor and chair of the division of dermatology at the University of British Columbia (Vancouver, British Columbia). "If you don't have enough pigment in the hair, you will not absorb enough photons of light. Without this absorption, there will not be sufficient heat to cause local destruction of the hair follicle."
In contrast, the effects from Vaniqa "appear to be independent of hair color," Lui said. The mechanism of action is totally different. "The growth of hair depends on multiplication of cells in the hair bulb. Certain chemicals are necessary to sustain the growth cycle of hair. Vaniqa controls the effects of some of these chemicals by blocking one of the enzymes, which in turn slows down or even arrests hair growth." A split-face comparison study conducted by Lui found an overall increased benefit with Vaniqa and laser treatment combined, compared to either laser or Vaniqa alone. "With the combination treatment, you can probably enhance results by 20% to 30%," he said.
Results of another split-face comparison were presented at the annual meeting of the American Academy of Dermatology (Schaumburg, Illinois) in San Francisco, California, in March. Subjects applied either Vaniqa or placebo medication twice daily for 34 weeks. Patients also underwent laser hair removal at two weeks and then again at 10 weeks. "Patients were able to identify a benefit to the Vaniqa-treated side of the face in roughly 75% of cases," said clinical investigator Stacy Smith, MD, an assistant clinical professor of dermatology at the University of California, San Diego. Regarding safety, the study found no differences between Vaniqa and the placebo-treated sides in frequency of use or types of adverse reactions. But starting at the first follow-up visit at two weeks, patient ratings were consistently higher for adjunctive use of Vaniqa. "Data bears out that patients were very satisfied with the treatment," Smith noted. "These Vaniqa patients are definitely more involved in their care and motivated to find out how this drug is working. In fact, most patients continued a prescription after the study was completed."
Smith prefers that his patients begin Vaniqa use at least two weeks before their first laser treatment. The product is very similar to Propecia or Renova, in the sense that they are all long-term, slow-result therapies. "Adding Vaniqa to one's practice can potentially have a positive benefit on revenues," he pointed out. Besides increased patient satisfaction, "you are offering a more complete hair removal package than simply providing laser treatment. You can prescribe and dispense this product directly out of your office."
According to research, an effective off-label use of Vaniqa is for treating pseudofolliculitis barbae (PFB). "I use Vaniqa in combination with other agents that treat PFB," said Valerie Callender, MD, a dermatologist in private practice in Mitchellville, Maryland, who estimates that this combination therapy is effective approximately 80% of the time.
Patients of Callender first undergo laser hair removal with the CoolGlide from Altus Medical (Burlingame, California), a long-pulse Nd:YAG laser system. Three sessions are usually required, at four-week intervals. "Patients start on Vaniqa one week after the first treatment," she said. In addition, after the second treatment, patients begin a combination hydroquinone/glycolic acid cream (GlyQuin XM). "This therapy addresses not only the PFB, which is the hair curling under the skin, but also the hyperpigmentation that results from the PFB. At the end of the third treatment, patients usually have about an 80% success rate." Vaniqa also "works very well in women with PFB, which is a population that has not been addressed for treatment," Callender added.
Iltefat Hamzavi, MD, is a dermatologist in private practice in Detroit, Michigan, who specializes in photomedicine and lasers. "Based on studies we have performed, Vaniqa can improve the response of laser hair removal," he confirmed. "Laser treatment alone will normally achieve a 67% to 75% reduction in hair count. Adding Vaniqa, however, will increase those reductions to about 94%. Overall, there is a faster and greater rate of response compared to placebo."
Laser and Vaniqa combination therapy is particularly helpful in patients "who have gray or blonde hair," said Hamzavi, a clinical professor of dermatology at Wayne State University (Detroit). "Vellus hair can also be effectively treated, for which laser hair removal alone is ineffective."
His study protocol involved laser hair removal once a month, for up to six months. In addition, 50% of patients received Vaniqa and the remaining 50% applied a placebo cream. The placebo group achieved about a 67% response rate for all types of hair as opposed to nearly 95% with Vaniqa. "There is usually a faster clearance within three treatments with Vaniqa," Hamzavi said.
The lip and chin are the two most popular areas to treat. For an upper lip, he charges between $145 and $175 per session, not including the prescription cost of Vaniqa. About 80% of his patients are women. "By prescribing Vaniqa, I think practitioners will retain more patients because some patients are unhappy with the overall effect of laser hair removal alone," Hamzavi said.
Vaniqa received FDA approval in July 2000 as the first and only topical prescription treatment for women with unwanted facial hair. It was developed through a partnership formed in 1996 between Gillette (Boston, Massachusetts) and Bristol-Myers Squibb (New York). In June 2002, Women First HealthCare (San Diego, California) acquired worldwide rights to this product and began marketing it in the U.S. Women First HealthCare recently launched its Vaniqa Direct program to permit dispensing of Vaniqa directly by physicians.
ThermaCool's tissue-tightening capability
The facial tissue tightening effects of the ThermaCool TC System from Thermage (Hayward, California) are gradual and impressive, according to several clinical presentations at the American Society for Laser Medicine and Surgery (ASLMS; Wausau, Wisconsin) annual meeting, held earlier this year in Anaheim, California.
"There is nothing else in the minimally invasive realm that tightens tissue like ThermaCool," said Brian Zelickson, MD, an assistant professor of dermatology at the University of Minnesota (Minneapolis, Minnesota). "Most patients are satisfied with treatment, but it usually takes about three to four months to see results. At one month, though, most patients notice a tightening of the area that has been treated."
Zelickson was principal investigator of a histological and ultrastructural evaluation of this non-ablative, radio frequency (RF) technology. The investigators found changes in collagen fibril morphology, as well as increased collagen mRNA. "We usually perform one session initially, then wait about three months to determine if additional treatment is needed," Zelickson said. "We seem to achieve some improvement in the lower chin and jowl areas. Patient selection focuses on early signs of laxity in these areas, but the techniques and protocols are still evolving."
Richard Fitzpatrick, MD, a dermatologist in private practice in Encinitas, California, headed up the first multi-center clinical study of ThermaCool. These researchers found that at four months post-treatment, 61% of treatment areas (periorbital wrinkles and brow skin) rated a significant improvement in the Fitzpatrick wrinkling score. By six months, 80% of treated areas showed greater improvement. "We're able to tighten loose skin without downtime," said Fitzpatrick, who has treated between 200 and 300 patients. "Overall, patients are happy. Results are better than we expected."
The ideal candidate is someone with early laxity. "I tell patients it may take anywhere from one to three sessions," he commented. "But we don't like to perform repeat treatments until we see something happening from the first treatment." Two months is the typical interval between sessions for Fitzpatrick's patients. However, "in some patients it has taken a full six months before noticing a change," he noted.
"Although there can be significant change with only one session, I've been very impressed with the results from two or three sessions," said Douglas J. Key, MD, medical director at the Key Laser Institute for Aesthetic Medicine (Portland, Oregon). "Instead of simply holding up a mirror to our patients, we need to point out specific areas of improvement, such as around the eyes or cheeks." By using this approach, "every one of our patients comment that they didn't realize how much they improved," reported Key, who has treated more than 200 patients with ThermaCool.
In a study of 30 patients, who received two or three treatments (four weeks apart), he demonstrated significant improvement in rhytides and subdermal skin laxity at six months. Besides incorporating baseline photography and isolating the gravitational effect of the full facial mask, Key has dramatically enhanced his results by integrating ThermaCool with non-ablative modalities, lipografting and facial liposculpture.