Light emitting diode-red light for reduction of post-surgical scarring: Results from a dose-ranging, split-face, randomized controlled trial

Abstract

Scarring has significant esthetic and functional consequences for patients. A need exists for anti-scarring therapeutics. Light emitting diode-red light (LED-RL) has been shown to modulate skin fibrosis. The aim of this study is to evaluate the safety and efficacy of LED-RL to reduce post-operative scarring. Cutaneous Understanding of Red-light Efficacy on Scarring was a randomized, mock-controlled, single-blind, dose-ranging, split-face phase II clinical trial. Starting 1 week post-surgery, patients received LED-RL irradiation and temperature-controlled mock therapy to incision sites at fluences of 160, 320 or 480 J/cm2 , triweekly for 3 weeks. Efficacy was assessed at 1, 3 and 6-12 months. The primary endpoint was difference in scar pliability between LED-RL-treated and control sites. Secondary outcomes included Patient and Observer Scar Assessment Scale, collagen and water concentration, and adverse events. There were no significant differences in scar pliability between treated and control scars. At certain fluences, treated scars showed greater improvements in observer rating and scar pliability, reflected by greater reductions in induration, from baseline to 6 months compared to control scars. Treatment-site adverse events included blistering (n = 2) and swelling (n = 1), which were mild and resolved without sequelae. LED-RL phototherapy is safe in the early postoperative period and may reduce scarring.

Keywords: low level light therapy; phototherapy; scarring; wound healing.

Conflict of interest statement

Conflict of Interest

Dr. Jared Jagdeo and Dr. Daniel Siegel are on the Scientific Advisory Board for Global Med Tech. Dr. Jared Jagdeo also serves as a consultant for Global Med Tech. The other authors have no conflict of interests to declare.

© 2021 The Authors. Journal of Biophotonics published by Wiley-VCH GmbH.

Figures

Figure 1.

Schematic of study design for the CURES trial.

Figure 2.

Custom-designed headset containing an LED-RL treatment device and mock phototherapy device on opposing sides.

Figure 3.

The low and medium dose-treated scars in (Groups 1 and 2) showed greater improvements in scar pliability compared to the control scars. (A) In group 1 (low dose), the treated scars showed a 62.5% decrease in induration from baseline to 6 months compared to a 40.0% decrease for the control scars. (B) In group 2 (medium dose), the treated scars showed a 77.8% decrease in induration from baseline to 6 months compared to a 50.0% decrease for the control scars.

Figure 4.

The low and medium dose-treated scars in (groups 1 and 2) showed greater improvements in observer rating from baseline to 6 months compared to the control scars. (A) In Group 1 (low dose), the treated scars showed a 45.5% improvement from baseline to 6 months compared to 24.2% for the control scar. (B) In Group 2 (medium dose), the treated scars showed a 57.9% improvement from baseline to 6 months compared to no improvement for the control scars.

Figure 5.

Control scar compared to low dose LED-RL-treated scar (group 1) at 6-month visit.