Background and Objective: To determine the efficacy and safety of the ThermaCool 1 TC radiofrequency system for treatment of hypertrophic and keloid scars and evaluate treatment associated collagen changes. Materials and Methods: Six subjects with hypertrophic and four with keloid scars were treated with the ThermaCool 1 device: one-third of the scar received no treatment (control), one-third received one treatment and one-third received two treatments (4-week interval). Scars were graded before and then 12 and 24 weeks after treatment on symptoms, pigmentation, vascularity, pliability, and height. Biopsies were taken from four subjects with hypertrophic scars and evaluated with hematoxylin and eosin (H & E) staining, multiphoton microscopy, and pro-collagen I and III immunohistochemistry. Results: No adverse treatment effects occurred. Clinical and H & E evaluation revealed no significant differences between control and treatment sites. Differences in collagen morphology were detected in some subjects. Increased collagen production (type III > type I) was observed, appeared to peak between 6 and 10 weeks posttreatment and had not returned to baseline even after 12 weeks. Conclusion: Use of the Thermage radiofrequency device on hypertrophic scars resulted in collagen fibril morphology and production changes. ThermaCool 1 alone did not achieve clinical hypertrophic scar or keloid improvement. The collagen effects of this device should be evaluated further in order to optimize its therapeutic potential for all indications.
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