Split-face study to evaluate efficacy of global cryomodulation for reduction of pain and inflammation after nonablative fractional resurfacing

Objectives: Cryomodulation, or the delivery of controlled cooling to down-regulate inflammatory processes in the skin, has been proposed to mitigate acute side effects following various dermatologic treatments. A new controlled cooling device has been developed to deliver cryomodulation for a range of different indications. In this clinical study, we evaluate the device for the reduction of pain, erythema, and edema following nonablative fractional resurfacing (NAFR). Methods: A single-blind, prospective, randomized, split-face study was conducted to assess the efficacy of the controlled dermal cooling device for the reduction of pain, edema, and erythema following nonablative fractional resurfacing with the dual 1550 nm erbium-doped fiber and 1927 nm thulium fiber laser. Subjects were randomized to receive a 10-min controlled cooling treatment to either the left or right side of the face immediately following full face NAFR. Pain ratings were recorded immediately postlaser treatment and immediately postcryomodulation treatment. At follow-up, subjects were surveyed for reduction of side effects and treatment satisfaction. Blinded review of photographs by two physicians was conducted to assess efficacy. Results: The average pain score for subjects immediately post-NAFR was 5.15. Following cryomodulation, the average pain score on the treatment side was reduced by 69%, to an average of 1.6. The untreated side of the face was reduced by 19%, to an average of 4.2. Overall, 90% of subjects endorsed reduced discomfort. At follow-up, 70% of subjects reported a noticeable improvement in edema and 50% reported a noticeable improvement in erythema between the treatment and control sides. The average subject satisfaction score for the cryomodulation treatment was 4.2. All subjects (100%) indicated that they would elect to undergo the cryomodulation treatment again. Both blinded physician reviewers were successful in identifying the cryomodulation-treated side of the face in 70% of subjects' posttreatment photographs. Conclusions: The results of this split-face study support the efficacy of a global cryomodulation device for the reduction of pain, edema, and erythema following NAFR treatment. Cryomodulation was delivered in a simple 10 min procedure and yielded high patient satisfaction.