Treatment of mild-to-moderate acne vulgaris using a combined light and heat energy device: home-use clinical study.

ABSTRACT

INTRODUCTION: Light and heat devices have become widely used for the treatment of mild-to-moderate inflammatory acne as an alternative to retinoids and antibiotics. The purpose of this study was to examine whether a hand-held device that emits both light and heat energy can safely and effectively be applied at home to shorten the time to improvement and time to resolution of acne papules and pustules. METHODS: A two-center, randomized, placebo-controlled, double-blind study was conducted on 63 subjects with at least four inflamed, facial, acne lesions. Treatments were self-administered twice a day for 4 days. All lesions were photographed on a daily basis. Treatment results were assessed by two blinded evaluators, based on the macro photographs, using a 4-point visual analogue scale (VAS) and a photographic lesion reference scale (PLRS), as well as by the subjects. Safety was assessed based on evaluators and subjects' reported side effects and adverse events. RESULTS: Twenty-nine subjects in the treatment arm and 32 subjects in the placebo arm, with skin types II-VI, successfully completed the study. Based on blinded VAS scores, 92.24% of the lesions treated with an active device improved within a median time of 1 day versus 75.78% and a median time of 2 days for the placebo arm. At 24 hours the improvement rate was 76.72% for the active arm versus 15.63% for the placebo arm. Based on blinded PLRS scores, 87.07% of the lesions treated with an active device improved within a median time of 2 days versus 64.8% and 3 days for the placebo. A total of 51.7% of the active arm lesions resolved within a median time of 4 days versus 36% (no median) for the placebo arm lesions. No device-related adverse events occurred throughout the study. CONCLUSION: This study demonstrates the safety and effectiveness of the hand-held, combined light and heat energy device for at-home treatment of individual mild-to-moderate inflammatory acne lesions. Statistically significant shorter lesion improvement and lesion resolution rates were found.