Nonablative fractional laser resurfacing for the treatment of hypertrophic scars: a randomized controlled trial.

BACKGROUND: Nonablative fractional laser (NAFL) therapy is a noninvasive procedure that has been suggested as a treatment option for hypertrophic scars.

OBJECTIVES: To evaluate the efficacy and safety of 1540-nm NAFL therapy in the treatment of hypertrophic scars.

MATERIALS AND METHODS: An intraindividual randomized controlled trial (RCT) with split lesion design and single-blinded outcome evaluations. Patients received four NAFL treatments at monthly intervals. Primary endpoint was a blinded on-site visual and palpable Physician Global Assessment (PhGA). Adverse event registration and pain evaluation were used to evaluate safety. Patient global assessment (PGA) was a secondary endpoint to additionally evaluate efficacy.

RESULTS: The PhGA did not find a statistically significant difference between the treated and untreated control side of 18 patients, although there was significant difference on the PGA 1 (p = .006) and 3 (p = .02) months after last treatment (Wilcoxon signed rank test). Patients experienced moderate pain during treatment and mild adverse events.

CONCLUSION: In this trial, blinded PhGA could not confirm the clinical efficacy of 1540-nm nonablative fractional laser in the treatment of hypertrophic scars, but the treatment is safe, and patients judged that the treated part had a better global appearance.