ThermaCool is a radio frequency device developed by Thermage, Inc. (Hayward, CA, www.thermage.com). This device uses a new form of delivery of radio frequency so that the energy is transmitted through larger areas of the skin. During delivery of this radio frequency pulse the upper layer of the skin – the epidermis – is protected by cool cryogen spray. Thus the radio frequency energy can heat deeper tissue without inducing a superficial skin burn. This controlled heating of deeper layers of skin and other tissue causes skin contraction and tightening and is referred to as volumetric tissue heating. An immediate effect of volumetric tissue heating is collagen contraction or shrinkage. A secondary or later effect is collagen remodeling and production of new collagen as well as continued tightening over time as the skin heals.

With each pulse ThermaCool delivers controlled, uniform, and sustained heat in the tissue underneath the surface of the skin. This produces bulk or volumetric tissue heating that may result in contraction and tightening of flaccid or lax skin. The upper layer of the skin is protected from this heating by cryogen cooling of the treatment tip which keeps the temperature of the epidermis constant while deeper tissues are heated.

Tightening skin in certain key areas can be advantageous for cosmetic improvement, for example:  Treating the skin of the forehead can lift the eyebrows and enhance the appearance of the eyes, making the eyes look more open, less tired, more alert.  Previously, this result could only be obtained with major surgery or BOTOX®.  Other areas of the face such as the skin of the cheeks can also be treated to reduce flaccidity, which produces deep folds with aging.  Other applications are currently being tested and include the neck, chest, elbows, knees, and loose skin of the abdomen. The only current FDA approved application of ThermaCool is the forehead and eye area; however, other areas are commonly treated (treatment of areas other than the forehead and eye area would be a non- FDA approved use of the device).

Each time the machine is fired, there is a sensation of heat in the area. Fortunately, this heat sensation lasts only fractions of a second and is followed by a cool sensation, which also helps reduce discomfort. Initial treatments with ThermaCool were done with the use of a topical anesthetic cream; however, more experience has shown that this is not helpful and may even increase pain because it numbs the cooling sensation from the cryogen spray, which is delivered before, during and after the application of heat. Most patients experience at least moderate pain during the treatment. Some areas are more sensitive than others (jaw line for example). Nerve blocks (injections) may be used in the forehead to reduce pain. We strongly encourage oral analgesic medications prior to your treatment. Use of these medications requires that you have transportation home after your treatment as you will be unable to drive. Pain after treatment is infrequent and typically consists of mild soreness.

Treatment times depend on the size of the area to be treated and the number of passes planned. Typical treatment times for the cheeks and forehead is 30- 45 minutes each area. Other areas may require more time to treat.

You may continue the use of your topical creams or medicines taken by mouth up until the time of the procedure. No special preparation is required; however, the results of your treatment may be enhanced by use of products that promote skin healing and rejuvenation and enhance collagen production. All makeup and creams will be completely removed prior to the start of your treatment.

You may return to your activities immediately, as there is usually no down time.  Minimal redness is seen in some patients but it disappears within an hour.  Swelling and pain are uncommon after the procedure.  Occasionally there is significant swelling that may be noticeable and typically lasts 24 hours up to several days. There is no special care needed afterwards unless you develop crusting which can occur rarely.  If crusting is seen, then Bacitracin or Polysporin ointment should be applied twice daily.

Although in some patients the results are seen immediately, in most patients they will appear gradually over 2 to 6 months.  Since the effects are so gradual, you may not be aware of the extent of the changes. Visual comparison with pre-operative photographs usually will demonstrate the changes. Results however remain variable so that some patients get much better results than others. It is possible that the results you achieve may not be as great as you would like or expect. Treatment with ThermaCool is not as predictable as surgery. We try to maximize your potential for a great outcome by using as high an energy as indicated by skin type and thickness, and by careful placement of treatment grids. Studies have shown that greater than 70% of patients feel that get improvement from ThermaCool.

For many patients one treatment will suffice.  Repeat treatments may be beneficial. You will probably reach your maximum improvement in 3 – 6 months. At that time if you wish to achieve greater improvement, another treatment may be considered. For significant skin laxity, it is very likely that more than one treatment will be required to achieve the best results.

A decision regarding further treatment can be made as early as one month; however, since benefits are delayed, further treatment may be postponed for several months.

The studies to date demonstrate that there may be a variable response. It is likely that any tightening you achieve will be maintained for one year to as long as several years, but this is not currently know because the technology is so new. The few patients initially treated about 2 years ago appear to have maintained their results. We ask most patients to expect to have repeat treatments every 1 to 3 years in order to maintain results and continue to fight ongoing skin laxity and aging.

It is extremely safe.  Although this is a relatively new procedure and a new technology, great effort has been made to make is as safe as possible. The number of adverse events is extraordinarily small. Small, superficial burns have been reported in a few patients. These burns appear to have occurred by not completely removing topical numbing creams (which are currently not used by most practitioners).  Some patients have experienced temporary nerve injury in superficial sensory nerves resulting in mild numbness that recovered with time. A very small number of patients have had small depressions in the skin over the treated area. This correlates to use of too high a energy, so we carefully choose an energy appropriate to the area being treated. At the time of this writing, the number of complications of which we are aware is less than a dozen in thousands of ThermaCool treatments performed.

http://www.thermage.com

http://www.wired.com/news/medtech/0,1286,61967-2,00.html?tw=wn_story_page_next1

http://www.oprah.com/health/beauty/health_beauty_treatments.jhtml

http://abcnews.go.com/sections/GMA/HealthyWoman/GMA031107Thermage-1.html