Leg Vein Treatments
Promising procedures and greater patient comfort.
T hough radiofrequency is not a new technology and has had FDA approval as a leg vein treatment since March 1999, it’s really starting to gain momentum as a standard treatment choice with dermatologists.

Robert Weiss, M.D., says many dermatologists were wary of the decision when the technology was first approved because they believed it was too hazardous or too invasive to do in their office. For the VNUS Radiowave Occlusion Closure procedure that Dr. Weiss uses, you administer tumescent anesthesia around the vein, then insert a thin catheter into the vein through a small opening to deliver radiofrequency (RF) energy to the vein wall, causing it to heat, collapse, and seal shut. This allows other healthy veins to take over and empty blood from the leg. Once dermatologists understand what the procedure actually entails, they realize that is requires skills they possess, says Dr. Weiss.

He believes it’s pretty typical for a new technology to take about 10 years to really catch on, explaining that even laparoscopy took about that long to become standard.

At his practice at the Maryland Laser, Skin and Vein Institute, Dr. Weiss says about half of his patients seek anti-aging cosmetic treatments and half are there for leg vein treatments.

“The most thankful are those leg vein patients we saved from the pretty invasive stripping procedure.” Many patients who were horrified by the possibility of going through the stripping procedure now have this alternative. As opposed to the invasive stripping procedure, which requires general anesthesia, the Radiowave Occlusion Closure procedure involves administration of a tumescent anesthesia and takes about 45 minutes to
1 hour. The procedure can be used on all types of veins, but Dr. Weiss does say at times he’ll use ambulatory phlebectomy in conjunction to treat smaller branches.

A Look at the Results
Long-term effects of radiofrequency treatments look good so far. Dr. Weiss says he’s seen back all of the patients he had treated in 1999, and 90% appear to have no veins, giving the impression the veins were surgically removed. The other 10% still have the veins, but they’re very small from treatment, and these patients no longer suffer from any symptoms. He had one patient who needed retreatment because he didn’t use enough RF energy.

Patients quickly see results and have little down time. “I’ve had patients golf the next day,” adds Dr. Weiss.

The main side effect Dr. Weiss has seen in his patients — he’s seen it in less than 1% of them — is a small area above or below the knee with decreased sensation that may last from 3 to 6 months.

On the Horizon
Currently, Dr. Weiss is working on a study of a foamed sclerotic agent, which is a can of air or oxygen mixed with a sclerosing solution. The foam, Varisolve, was manufactured by UK company Provensis and is available in Europe. Dr. Weiss explains that when the foam is injected, it shrinks varicose veins. European data show a 90% success rate. One rare side effect seen in early studies was deep venous thrombosis in two patients.

He is now working with Provensis to obtain FDA approval and is working on the initial stages of a Phase II clinical trial, which started in September. They are scheduled to treat 60 patients and are currently working on 10 patients. So far, he adds, results are very good and the treatment looks promising.

Non-Ablative Laser Rejuvenation
A look at its effectiveness.
T his year, there’s been a shift away from ablative, aggressive laser skin resurfacing toward non-ablative resurfacing. A number of new lasers and intense pulsed light sources have been developed and have received FDA indication for treating wrinkles and acne scars.

Benefits include little to no down time, no side effects and improved scars and wrinkles. However, much discussion has been sparked about subtle results many dermatologists are seeing and the lack of clinical data to support non-ablative lasers for treating these conditions.

So just how affective are these non-ablative lasers? To answer this question, Paul Friedman, M.D., Roy Geronemus, M.D., and colleagues performed a study using an in vivo, 3-D optical skin imaging device (Primos Imaging System) to quantify the skin textural changes resulting from non-ablative laser treatments. This system generates 3-D, virtual models of the skin surface at variable time points so surface microtopography can be compared in an objective, quantitative way.

Dr. Geronemus, president-elect of the American Society for Dermatologic Surgery, explains that many physicians need a quantitative measurement to convince them of this treatment value.

Setting up the Study
For this study, reported on in the March issue of Dermatologic Surgery, the investigators studied two patients in a nonblinded, uncontrolled study. One had photo-damage-induced wrinkles (phototype II, class III rhytides) and the other had mild, atrophic acne scars.

The patients received five low-energy QS Nd:YAG treatments (3 to 3.5 J/cm2, 6-mm spot) every 2 to 3 weeks. Subjects were treated with multiple passes. The photo-damaged patient was treated at the wrinkled periorbital and perioral regions, while the acne-scarred patient was treated on the cheek from the nasolabial folds to the preauricular areas and jawline). Investigators reported that treatments were well tolerated and the end point was mild erythema.

Results were measured by subjective assessment and with the in vivo 3-D microtopography system coupled to a digital micromirror device (Texas Instruments). The physicians took in vivo topographic maps of the skin surfaces of the patients before, during and 6 months after treatment. With these maps, investigators studied the Rz (measures the mean peak-to-valley height) and Ra (averages the height of all points of the topographic profile) values.

The photo-damaged patient had an 11% decrease in skin roughness from baseline after three treatments and a 26% decrease 6 months after treatment. The acne patient had a 33% reduction in his Ra score after three treatments and a 61% reduction 3 and 8 months after treatment.

Assessing the Results
Although the study can’t undergo statistical analysis because it was too small and not controlled, results show quantitative improvement.
Dr. Geronemus continues to use this device for non-ablative studies. “We continue to see excellent results for skin tone, fine lines and acne scars. This device offers an excellent method of demonstrating benefits to patients,” he says.

Filler Substance Update
New and emerging trends.
W hile Botox has received the most press, the filler substance market in general has been exploding with new developments and products that are being considered for FDA approval.

Botulinum toxin. Botox Cosmetic, which is made from type A, though technically not a filler, does have FDA approval for temporary treatment of moderate to severe glabellar lines in men and women aged 65 or younger. The U.S. Botox market may soon see some competition from another botulinum toxin type A, Dysport, which is already available in Europe.

And then there’s Myobloc, a botulinum toxin type B, which is currently under study for FDA approval and could serve as an alternative to Botox and Dysport.

Hyaluronic acid. These derivatives, like Restylane, Restylane Fine Lines and Perlane, are already approved for and available in Canada and Europe and currently under review for FDA approval in the United States. Lance H. Brown, M.D., and Paul J. Frank, M.D., reported on these filler substances in the April 2002 issue of Skin & Aging, as a promising alternative to collagen.

Hyaluronic acid is biocompatible and holds significantly less risk for allergic hypersensitivity reactions associated with bovine collagen. These products, unlike collagen, don’t require a skin test. Restylane, which is made from a bacterial source, may also last longer in tissue than current collagen products. A 1998 study by Duranti et al looked at 158 patients being treated with Restylane and found that 78% of patients maintained a moderate to marked clinical improvement of treated sites after 8 months. The study also found that though 12.5% of patients had localized, transient adverse effects, no long-term or delayed reactions were reported.

Hylaform, a hyaluronic acid filler made from rooster combs rather than bacteria, is also currently under investigation.

Collagen. A promising new collagen that Arnold Klein, M.D., discussed at the Annual Summer AAD meeting in August, is Cosoderm. This bio-engineered human collagen from Inamed Corp., is currently being studied and holds promise for patients sensitive to bovine- and cadaver-based collagens.

Cosmoplast is another bio-engineered human collagen currently under study.
Also, Artecoll is a non-biodegradable, non-removable filler with collagen pending FDA approval.

More Fillers
Many dermatologists are anticipating a resurgence of silicone as a permanent, inexpensive filler that also doesn’t require skin testing. Dr. Brown says one problem with silicone is that it’s difficult to use for physicians not trained in the microdroplet injection technique, but believes silicone will be a promising treatment in the near future.

Fat transfers are also popular. Benefits include long-lasting results, potential to harvest large quantities, ability to freeze for later use and lack of need for testing since patients are injected with their own fat. Dr. Brown says patients like the long-lasting results and that this is an non-foreign, non-allergenic filler.

With so many options available you may want to follow advice Dr. Klein shared at the Summer AAD meeting to pick a few agents you like, stick with them and become a master with them.

Hair Cloning
Will we soon be able to regenerate hair?
W e’re all born with around 100,000 hair follicles, and though we can lose them, we never grow any more. At least, not yet.

While there are some good, solid treatments to help stop hair loss or thinning, and while hair transplants are constantly improving, the real fantasy is to create new hair follicles, explains Ken Washenik, M.D., Ph.D., medical director of Bosley Medical, a hair restoration practice. And that’s just what he and colleagues hope to do at the Aderans Research Institute (ARI), an affiliate of Bosley Medical, which opened in July.

The Need for Hair Regeneration
One of the major limits of traditional hair transplants is that you aren’t creating any new hairs, just moving them from one part of the head to another. This may work for men who only lost hair from the top of their head and still have hair on the back of their heads to pull from, but women who lose hair all over don’t have as much success with the transplant. Hair follicle neogenesis, or hair cloning, would allow these types of patients, along with those with hair loss from a burn or from a surgery scar, to have a better treatment option.

The idea behind hair follicle neogenesis is to isolate follicular fibroblasts with hair inducing ability that we already have in our existing hair and culture them to grow and multiply into thousands, and then implant them back into the skin, says Dr. Washenik. The key is learning exactly how the follicular fibroblasts should be injected so that the seeds can induce growth.

Tried and Proven
Though hair cloning is really in experimental tests at this time, proof exists that the concept does work. Dr. Washenik explains that in November 1999 an article was published in Nature outlining the work of Colin Jahoda who took follicular fibroblasts from his scalp, isolated and cleaned the cells and injected them into the forearm of a woman researcher he was working with. Hair did grow on her arm — DNA tests showed the hair had male DNA. “This,” Dr. Washenik says, “proved that, yes, human follicular fibroblasts can induce the creation of a new hair follicle.”

This theory was tested and proven again. Dr. Washenik says that this past winter a polymer chemist presented at an organ tissue engineering conference that he isolated. cleaned and cultured follicular fibroblasts, then injected cells back into the same man and the man grew a hair.

So now it’s back to the lab room. “The concept was proven, now we have to step back and work on the whole process,” says Dr. Washenik. “We need to approach the process very scientifically and make sure it will reproducibly work.”

The hypothesis now is: If you inject 100 “inductive” packets, will they all produce hair — do they all always have inductive potential? Dr. Washenik believes that they are well on the road to answering this question and proving that it can be done now that they have initiated a research institute with its entire focus on hair. Kurt Stein, M.D., and Thomas Barrows, Ph.D., are two of the scientists working this project full time. Dr. Washenik is working with both at ARI to find the molecular growth factors needed and the exact ways the follicular fibroblasts need to be injected for this process to induce hair growth in a consistent fashion.

What the Future May Hold
Dr. Washenik is confident that in about 5 years, this will either be widely available or be in the later stages of FDA studies.

He hopes that by then patients can go to a hair restoration surgeon where the physician would perform a conventional hair transplant and then take a small sample of donor hair to send off to a lab. The lab would then isolate the fibroblasts, multiply them and then send thousands back to the doctor for implantation. The doctor would then inject them to induce hair regeneration in the patient.

For now, Dr. Washenik says, they’re looking at an autologous process, but in the future sees the potential for a universal donor bank — or allogenic source of inductive cells — readily accessible to many patients.