Safety and Effectiveness of a Thermo-Mechanical Fractional System at Low Settings for the Treatment of Photodamage

Abstract

Objective: To evaluate the efficacy and safety of a thermo-mechanical fractional device for the treatment of photodamaged skin.

Methods and materials: Twenty-five subjects received three thermo-mechanical fractional device treatments at monthly intervals. Low treatment settings of a 5 ms pulse duration and 100 μm tip protrusion were administered in 1-2 passes. Digital images were evaluated for improvement on the Fitzpatrick Wrinkle Classification Score 3 months after the final treatment. Secondary efficacy endpoints included ratings on a Global Aesthetic Improvement Score and Subject SatIsfaction Questionnaire.

Results: Forty-eight percent of subjects demonstrated a ≥ 1 score improvement in the Fitzpatrick Wrinkle Classification Score, and 96% of subjects demonstrated a good to excellent Global Aesthetic Improvement Score. Sixty-eight percent of subjects were "satisfied" to "very satisfied" with treatment results.

Conclusions: The thermo-mechanical fractional device at low settings is safe and effective for improving signs of photodamage with minimal patient discomfort.

Keywords: ablative; fractional; non‐ablative; protrusion; pulse duration; wrinkles.