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A Prospective Multicenter Study of Efficacy and Safety

Roy C. Grekin, MD; Whitney D. Tope, MPhil, MD; John M. Yarborough Jr, MD; Ingrid H. Olhoffer, MD; Peter K. Lee, MD, PhD; David J. Leffell, MD; Christopher B. Zachary, FRCP

Arch Dermatol. 2000;136:1309-1316.

Background  A novel electrosurgical technology that uses a bipolar electrode-tipped stylet to deliver relatively low-radiofrequency energy through an electrically conductive medium has been developed.

Objective  To evaluate the efficacy and safety of the radiofrequency resurfacing system for the treatment of facial wrinkles.

Design  Multicenter, prospective, noncomparative study with longitudinal follow-up.

Setting  Four US academic dermatologic surgery clinics.

Patients  Ninety-five patients with mild to severe photodamage (Fitzpatrick classes I-III) involving periorbital (75 treatment sites) and perioral (50 sites) facial skin.

Intervention  Radiofrequency resurfacing with the use of 2 to 3 passes at 125 or 139 V.

Main Outcome Measures  Wrinkle and cosmetic improvements evaluated by patients, investigators, and, by means of photographs, an independent panel of 5 evaluators.

Results  All evaluators determined a positive mean improvement in wrinkles for both periorbital and perioral anatomic sites, with greater improvement for patients with more severe wrinkles at baseline. An increased number of passes and higher voltage settings had a positive impact on wrinkle improvement. Transient postinflammatory hyperpigmentation occurred in 26% of periorbital and 4% of perioral sites. Hypertrophic scars occurred in 3.8% of treatment sites, with all but 1 scar resolving by 6 months. For the most part, healing was rapid, pain was minimal, and erythema largely resolved within 2 months. Other untoward effects were relatively few and short-lived.

Conclusions  At the study settings used, radiofrequency resurfacing is an effective modality in the treatment of periorbital and perioral wrinkles in patients with Fitzpatrick class I, II, and III photodamage. There is less severe postoperative morbidity than seen with carbon dioxide or coagulating erbium:YAG lasers. The potential risks are similar to those seen with other resurfacing modalities.

From the Department of Dermatology, University of California, San Francisco (Drs Grekin and Zachary); Department of Dermatology, University of Minnesota Medical School, Minneapolis (Drs Tope and Lee); Department of Dermatology, Tulane University School of Medicine, New Orleans, La (Dr Yarborough); and Departments of Dermatology and Surgery, Yale University School of Medicine, New Haven, Conn (Drs Olhoffer and Leffell). Drs Grekin, Leffell, and Zachary received stock options in ArthroCare for consultation before the beginning of the clinical trial.

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