Thermage-RF Treatments
Breakthrough or Broken Promises?

Paul Van Camp MD

The promise of RF is a face-lift without surgery. Tightening the skin and lifting sagging areas such as the forehead, eyelids and cheeks in a painless, safe and inexpensive procedure with no down-time. It sounds too good to be true, doesn’t it?

Yet that is exactly what the early reports on RF treatments suggested when they came out over the last year. The Thermage RF treatments (also called ThermaCool TC) have been basking in the limelight of national press coverage including a recent segment on the Oprah Show, and other popular programs. Now the phones at Aesthetics MD are ringing with inquiries about RF treatments and especially about the Thermage device.

RF stands for Radio-Frequency energy. It is not a laser and not a light-based device. Rather it is a form of electro-magnetic energy very similar to microwaves. The RF treatment passes radio frequency electricity through the skin to heat up the tissues. This is supposed to make the tissue contract and induce a response to cause tightening of the skin and to improve wrinkles. The Thermage RF system uses only this radio frequency energy. Another company (Syneron) makes a device called the Aurora using intense pulsed light and adding RF energy to it for a combination treatment.

Despite the early claims made when the devices came out, two important questions remain to be answered: Does RF work? And is it safe? Research has now been published which gives us some answers to these questions.

Initial reports presented by physicians who were testing the RF machines came out last April at the largest annual laser conference. They suggested that there were neither complications nor adverse effects seen with the treatments. However, this just didn’t make sense. When you heat the skin with microwave-like RF treatments you would expect some risk of burning the skin. No medical treatment is completely risk free. Therefore, I chose to wait for better data before considering RF treatments. That data has now been published. (Reference is at end of this article.)

The original investigators testing the Thermage RF system published their results on 86 patients. (This includes the physician who appeared on Oprah.) They followed the patients for six months after the RF treatments. Indeed there were serious complications: 17% of their patients experienced second-degree burns from the treatment. Many of these burns were considered "deep" second-degree burns. This resulted in 3.4% of the patients being scarred on their faces because of the RF treatments. This is a completely unacceptable degree of risk for an elective cosmetic procedure.

Moreover, what about comfort: do the treatments hurt? Physicians previously had stated that the treatments were "nearly pain free" for most patients. However, in the published study the authors admitted that there was some problem with pain during the treatments. In fact, these RF treatments tend to be very painful. Many patients required intravenous pain medicines to get through the treatment. It can feel like someone is burning your face — which in a way, they are.

So, what were the results of this process for the patients in the study? Did they achieve a "non-surgical facelift? Was it worth the trouble? Were they satisfied with the improvement?

The physicians claimed they achieved "a measurable lift effect" from the treatment. By carefully measuring the height of the eyebrows from the level of the pupils before treatment and again six months after treatment, they measured an average "lift" of 0.5 mm. One-half of one millimeter is the width of a line drawn by a medium ball-point pen! That is insignificant improvement. In looking very carefully at the before and after photos published with the study, one cannot discern a noticeable "lift" effect. Therefore, it is not surprising the patients tended to be disappointed.

The physicians reported in their research that just half of the patients (50%) were satisfied with the results. That is not a very good result. We should expect a cosmetic procedure to provide at least 90% of patients being highly satisfied. Thermage RF disappoints far too many who have undergone a risky and painful procedure.

This is the first controlled study published on the use of RF energy for facial rejuvenation. It used the Thermage ThermaCool device to deliver the treatments. The physicians who performed the study are highly experienced cosmetic physicians. Despite their tendency to state their results in a positive light, we can conclude the following: Radiofrequency (RF) treatments such as the Thermage ThermaCool do not provide substantial improvements in facial skin laxity or wrinkles when used in this manner. The treatments can be very painful and are accompanied by an unacceptable degree of risk of burning the skin including a 3.4% risk of scarring.

Other well established treatments such as Erbium laser skin resurfacing provide far greater degrees of improvement in wrinkles (typically 70% improved) and provide better skin tightening (typically 10- 15% tightening) with a far better safety record. Scarring is rare with laser skin resurfacing of the face using the Erbium laser (much less than 1%). For non-ablative treatments, FotoFacial intense pulsed light treatments have been proven far more effective while preserving an exceptional level of safety.

Perhaps the use of RF will be refined in the future and have a place to contribute to our choices of cosmetic treatments. For now, much better choices exist. Treatment regimens and recommendations must always be individualized. Interested persons should have a consultation with their cosmetic surgeon and obtain all of the facts, including risks and limitations, before deciding.

The study discussed was the "Multicenter Study of Noninvasive Radiofrequency for Periorbital Tissue Tightening", by Richard Fitzpatrick MD et al. published in Lasers in Medicine and Surgery Nov. 2003.

The above information is presented for educational purposes and not to recommend treatment for any individual or condition. Dr. Paul Van Camp is a cosmetic laser surgeon and is medical director of Aesthetics MD. Further information is available at www.aesthetics-md.com or by calling 330-6160.