Efficacy of phototherapy to treat facial ageing when using a red versus an amber LED: a protocol for a randomised controlled trial.

INTRODUCTION: The skin undergoes morphological and physiological changes with the advancing age of an individual. These changes may be caused by intrinsic and extrinsic factors that contribute to cellular ageing and consequent skin ageing. The term photoageing is used to characterise the ageing of the skin caused by solar radiation. Clinically, the skin becomes more flaccid, thicker and hyperpigmented, while there is an early appearance of wrinkles and other skin changes, such as skin cancer. Nowadays, there are numerous treatments for ageing skin, and one of them is with the use of phototherapy, which uses light-emitting diodes (LEDs). The objective of this study will be to evaluate the percentages of reduction in the volume of periocular wrinkles when treated with red and amber LEDs.

METHODS AND ANALYSIS: All of the participants will receive photobiomodulation to treat their periocular wrinkles. They will be using red and amber LEDs, with one colour being used on each hemiface. The facial side to be treated with each colour will be randomised. After an interval of 180 days, the participants will receive a cross-treatment. The primary variable of the study is the volume of periocular wrinkles (crow's feet), which will be measured by a VisioFace equipment. The secondary variables are elasticity (measured by Cutometer) and hydration (measured by Corneometer). Quality of life and self-assessment of the participants will be measured using the adapted Melasma Quality of Life scale - Brazilian Portuguese adaption (MelasQoL-BP) and Skindex-29 questionnaires. All of the variables will be measured before and after a group of 10 sessions.

ETHICS AND DISSEMINATION: This protocol was approved by the Research Ethics Committee of the Nove de Julho University (acceptance number: 2.550.732). This trial has been registered in the Registro Brasileiro de Ensaios Clínicos (Brazilian Clinical Trials Registry) (REBEC number: RBR-6YFCBM). This study is not recruiting yet.

TRIAL REGISTRATION NUMBER: RBR6YFCBM; Pre-results.