Newswise — As the baby boomers continue to age it is anticipated that the demand will increase for non-invasive techniques for facial rejuvenation and diminishing facial skin wrinkles and other body surface irregularities. Procedures used include dermabrasion, laser and chemical resurfacing; the long-term facial rejuvenation results of each require a short-term healing process of re-epithelialization, rebuilding of the cellular avascular covering of the affected area, and skin remodeling.
A new technology that allows radiofrequency energy to heat the dermis without removing the epidermis has been developed by Thermage, Inc., Hayward, CA. The applied heat causes a thermal injury, which causes a healing response to be initiated. . The device differs from previous radiofrequency devices in that it uses capacitive coupling rather than conductive coupling to deliver the therapeutic energy. (Note: Conductive coupling is based on energy concentrated at the tip of an electrode being delivered to a target. This results in heat production at the skin surface in contact with the electrode, which can produce a thermal injury to the dermis and would necessitate injury to the overlying epidermis. Capacitive coupling disperses energy across a surface to create a zone of temperature increase.)
By cooling the epidermis prior to administration of energy, a zone of heat production in excess of sixty-five degrees centigrade in the dermis, with temperatures ranging thirty-five to forty-five degrees centigrade is created within the epidermis. This heat zone allows the thermally sensitive collagen bonds in the dermis to exceed their denaturation threshold of sixty degrees centigrade. The device is reported to produce an immediate tightening of the skin, as well as collagen deposition and remodeling over time.
Early indicators are that the majority of patients who undergo radiofrequency without ablation see improvement within four to twelve weeks post-treatment. Even though the new device has been approved by the FDA for use in the periorbital region for treatment of rhytids there is sparse information available about the effectiveness and patient satisfaction association with the ThermaCool Device.
A new study reports the results of twenty-four patients who were treated with the ThermaCool TCTM device for elevation of brow position. The authors of "The Use of a Non-Ablative, Radiofrequency Device to Rejuvenate the Upper One-Third of the Face," are Benjamin A. Bassichis MD, Clinical Assistant Professor, Department of Otolaryngology-Head and Neck Surgery, University of Texas-Southwestern Medical Center and Director, Advanced Facial Plastic Surgery Center, P.A.; Steven Dayan MD, FACS, Clinical Assistant Professor, and J. Regan Thomas, MD, FACS, Professor and Chairman, both in the Department of Otolaryngology-Head and Neck Surgery, University of Illinois at Chicago. Their findings were presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation http://www.entnet.org Annual Meeting and OTO EXPO, being held September 21-24, 2003, at the Orange County Convention Center, Orlando, FL.
Methodology: A prospective study using this new radiofrequency procedure was performed on twenty-four patients at a facial plastic surgery office. The patients were not given any compensation for their participation, but did receive the treatment free of charge. The study group agreed to have pre-treatment and post-treatment photographs, as well as answering a questionnaire at the end of the study. A control group of twelve patients, subjects of another study that did not address the upper one-third of the face, were used for comparison purposes. The goals of the study were to objectively measure the amount of brow elevation following treatment, compare those results to the control group and to the pretreatment measures, and obtain a subjective measure of patient satisfaction with the procedure.
Results: Examination of preoperative and postoperative photographs and survey results found:
"¢ The amount of energy delivered to the treatment areas did not appear to affect the amount of brow elevation. Even in the ten patients who received nerve block local anesthetic (Lidocaine, one percent);"¢ In the majority of patients it was noted that statistically significant elevation of the eyebrow was found at one, two, and three months. Improvement was observed as time progressed. (This finding is consistent with the hypothesis that there are initial benefits, as well as longer-term changes in the dermal collagen architecture.) "¢ Although there are clearly improvements in the amount of brow elevation, many of the patients demonstrated asymmetry of greater than one mm elevation between each brow, and within the same brow, which could be a significant aesthetic consequence in certain patients."¢ The majority (81.8 percent) of patients was satisfied with the procedure and liked the ability to return to daily routine after leaving the office, thereby substantiating the trend in popularity of non-invasive rejuvenating procedures. The only patients who were not happy with the procedure were those who had pain that was not well tolerated during the procedure. However, when asked if they were satisfied with the results, the majority (64 percent) were not pleased and saw no results. Those that did see results (36 percent) did not think that they lasted very long, with the average being under four months."¢ The complication rate was very low, with no blistering, long lasting erythema, or induration.
Conclusion: The study found that the ThermaCool TMTM non-ablative, radiofrequency device for in-office rejuvenation of the upper one-third of the face provides a measurable improvement in the majority of patients treated. Eyebrow elevation is not consistent with similar energy settings in different patients, and the majority of patients showed post-treatment asymmetry within various brow locations.
The patients were pleased with the convenience of this non-invasive procedure, but the majority did not perceive a cosmetic benefit. In evaluating facial rejuvenation procedures, patient satisfaction with treatment effects is of paramount importance. Lack of patient satisfaction with the outcome of this ThermaCool TMTM treatment may outweigh any objective measurement of improvement evidenced in this study.
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