Results of New Study on Nonsurgical Facial Skin Tightening Published in Dermatologic Surgery

Dr. Brian Zelickson, medical director for Zel Skin & Laser Specialists, a cosmetic skin care clinic, and Dr. Jeffrey Dover, SkinCare Physicians, Chestnut Hill, Mass., are the lead authors of a study on nonsurgical facial skin tightening published in the August 2007 issue of the journal Dermatologic Surgery.

To date, this is the largest study in the world evaluating the effects of non–invasive tissue tightening procedures. In the study, 5,700 patients were surveyed to determine the optimal treatment methods and protocol for nonsurgical facial skin tightening, medically known as monopolar radiofrequency therapy.

Monopolar radiofrequency therapy is a non–ablative procedure that delivers heat to the deeper layers of the skin (dermis) while leaving the surface layer (epidermis) relatively unaffected and intact. The heating action causes collagen fibers, the material that supports the skin’s structure, to immediately tighten and also stimulates the gradual growth of new collagen, which further plumps up and tightens the skin.

Results of the study indicate that a new treatment protocol of using larger device tips at lower energy levels and multiple passes offers patients better results and satisfaction. The study results also show that patient feedback on the heat sensation is the preferred method for optimal energy selection based on an extensive questionnaire given to the 5,700 patients by 13 dermatologists, plastic surgeons and cosmetic facial surgeons across the United States and one in Hong Kong.

First cleared by the Food and Drug Administration for the treatment of wrinkles around the eyes in November 2002, radiofrequency therapy was cleared for treating the rest of the face in June 2004 and for skin treatment on the rest of the body in December 2005. Zel Skin & Laser Specialists offers several state–of–the–art radiofrequency technologies, with treatment options tailored to individual needs and desired outcomes.

A graduate of the University of Colorado and the Mayo Medical School in Rochester, Minn., Dr. Zelickson completed his post–graduate medical training at Hennepin County Medical Center and the Mayo Clinic Graduate School of Medicine. In 1990, he received special training at the University of North Carolina, Chapel Hill. He is a member of the faculty at the University of Minnesota Medical School’s Department of Dermatology and a director of the department’s Electron Microscopy Laboratory. Although he has extensive training in all aspects of dermatology, he is nationally recognized for his contributions to laser medicine and surgery. He has published more than 50 medical journal articles in the field and currently serves as the Government Liaison/Blue Ribbon Committee for the American Society for Laser Medicine and Surgery. In addition, he has completed specialized training in electron microscopy of the skin, cutaneous light and laser interactions, laser therapy, Botox and Restylane.

Susan E. Walgrave, MD, of Zel Skin & Laser Specialists, presents findings at ASLMS conference

Safety and Efficacy of Cryolipolysis for Non Invasive Reduction of Submental Fat

The American Society for Dermatologic Survey 2015 Survey on Cosmetic Dermatologic Procedures revealed that half of the patients surveyed were considering a cosmetic procedure. Top reasons specified were to look as young as they felt, to appear more attractive, and to feel more confident. The most common area of concern was excess weight, as reported by 88%, followed by skin texture and/or discoloration, reported by 72%, and lines and wrinkles around and under the eyes, reported by 69%. The fourth most common area of interest was excess fat under the chin and neck, as reported by 67% of respondents [1]. Another survey showed similar results; 77% of the patients surveyed reported noticeable excess fat under their chins and 61% expressed a desire to have submental fat reduced.

Background and Objectives: Cryolipolysis has previously received FDA clearance for fat reduction in the abdomen, flanks, and thighs. There is also interest in small volume fat reduction for areas such as the chin, knees, and axilla. This article reports the results of a cryolipolysis pivotal IDE study for reduction of submental fullness.

Study Design/Material and Methods: Aprototype small volume vacuum applicator (CoolMini applicator, CoolSculpting System, ZELTIQ Aesthetics) was used to treat 60 subjects in the submental area. At each treatment visit, a single treatment cycle was delivered at 108C for 60 minutes, the same temperature and duration used in current commercially-available cryolipolysis vacuum applicators. At the investigator’s discretion, an optional second treatment was delivered 6 weeks after the initial treatment. The primary efficacy endpoint was 80% correct identification of baseline photographs by independent physician review. The primary safety endpoint was monitoring incidence of device and/or procedure-related serious adverse events. Secondary endpoints included assessment of fat layer thickness by ultrasound and subject satisfaction surveys administered 12 weeks after final cryolipolysis treatment.
Results: Independent photo review from 3 blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicated mean fat layer reduction of 2.0mm. Patient questionnaires revealed 83% of subjects were satisfied, 80% would recommend submental cryolipolysis to a friend, 77% reported visible fat reduction, 77% felt that their appearance improved following the treatment, and 76% found the procedure to be comfortable. No device- or procedure-related serious adverse events were reported.
Conclusion: The results of this clinical evaluation of 60 patients treated in a pivotal IDE study demonstrate that submental fat can be reduced safely and effectively with a small volume cryolipolysis applicator. Patient surveys revealed that submental cryolipolysis was well-tolerated, produced visible improvement in the neck contour, and generated high patient satisfaction. These study results led to FDA clearance of cryolipolysis for submental fat treatment.