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Open Access Protocol Efficacy of phototherapy to treat facial ageing when using a red versus an amber LED: a protocol for a randomised controlled trial Lidiane Rocha Mota,1 Lara Jansiski Motta,1 Ivone da Silva Duarte,2 Anna Carolina Ratto Tempestini Horliana,1 Daniela de Fátima Teixeira da Silva,1 Christiane Pavani1 To cite: Rocha Mota L, Motta LJ, Duarte IdS, et al. Efficacy of phototherapy to treat facial ageing when using a red versus an amber LED: a protocol for a randomised controlled trial. BMJ Open 2018;8:e021419. doi:10.1136/ bmjopen-2017-021419 AbstrACt 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. IntroduCtIon The skin covers the body and has essential functions in maintaining the homeostasis strengths and limitations of this study ► Each woman participating in this study will be eval- uated before and after the treatment, and the reduc- tion in wrinkles will be measured. ► There is no control or placebo group and all of the participants will be treated; in this sense, each par- ticipant is in both the treatment group and the con- trol group. ► This split-face study will eliminate the individu- al factors of each participant that affect treatment outcomes. ► The VisioFace equipment will standardise the pa- rameters in acquiring photographs, such as light exposure, and it will minimise bias. ► Thehabitsoftheparticipantsmayaffecttheresults, as a consequence of their diet, their use of cosmet- ics and their exposure to the sun. ► Prepublication history for this paper is available online. To view these files, please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2017- 021419). Received 27 December 2017 Revised 19 April 2018 Accepted 24 April 2018 1Biophotonics Applied to Health Sciences Postgraduate Program, Universidade Nove de Julho (UNINOVE), Sao Paulo, Brazil 2Coordenação da Medicina, Faculdade de Pato Branco, Paraná, Paraná, Brazil Correspondence to Dr Christiane Pavani; chrispavani@gmail.com ultraviolet (UV) radiation. Once UVA radi- ation penetrates deeper into the dermis, the resulting oxidative stress causes damage to the elastin fibres and collagen. In addition, there may occur a decrement in physiological antioxidant reserves and/or in the protective capacity of the skin.2 The changes that are caused by ageing modify the physical proper- ties of the skin, leaving visible signs such as epidermal hyperplasia, irregular pigmenta- tion, telangiectasia, sagging tissues, a reduc- tion of collagen and elastin fibres, as well as a decrement in the natural moisturising factor. These changes result in the appearance of expression lines and creases.3 4 of an organism, presenting roles such as defence, thermoregulation and sensory awareness. Maintenance of healthy skin and integrity is extremely important.1 Exposure to the sun speeds up the intrinsic ageing of the skin, due to the formation of free radi- cals and reactive oxygen species, as a result of 1 Rocha Mota L, et al. BMJ Open 2018;8:e021419. doi:10.1136/bmjopen-2017-021419 1PDF Image | Efficacy of phototherapy to treat facial aging when using a red versus an amber LED
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