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Open Access Elasticity/Sagging Other non-invasive measurements of the facial region will also be performed. The viscoelasticity of the skin will be evaluated in the periocular region by Cutom- eter Dual MPA 580 (CK Electronic) instrumentation. Cutaneous elasticity is an important parameter because it provides indirect information on the quality and quan- tity of collagen and elastic fibres (structural fibres) that are degraded by the metalloproteinases. It is known that photoaged skin presents disorganised elastin and decreased collagen fibres.28 Hydration Skin hydration will be evaluated by a Corneometer CM 825 (CK Electronic) probe. This parameter is related to the amount of water in the dermis and epidermis, which allows for suitable skin functions.29 Quality of life and self-assessment by the participants The participants will respond to the quality of life and self-assessment questionnaires. An interview of around 20 min will be enough to get all of the participants’ answers. In terms of the quality of life, two adapted questionnaires will be applied. First, an adaptation of the questionnaire for the quality of life of participants with dermatolog- ical diseases will be used (Skindex-29).30 The second is the adapted version of the Melasma Quality of Life scale - Brazilian Portuguese adaption (MelasQoL-BP) ques- tionnaire.31 Due to these adaptations, the questionnaires will be evaluated in terms of reproducibility and internal consistency. For this, 20 participants, external to the main research, will respond to the questionnaires twice, with an interval of 30 days between answers. Statistical analyses will then be conducted. These particular participants will be duly informed about the research and, if they agree to participate in the study, they will sign the terms of free and informed consent. The rhytidectomy outcome eval- uation questionnaire will be performed before and after the phototherapy treatments for the verification of the self-assessment by participants.32 All of the measurements will be performed by LRM, who was previously trained by the CK Electronic’s representa- tive in Brazil. The VisioFace equipment has standardised illumination and face positioning in order to minimise any experimental bias. The questionnaires will be applied by LRM. The data that will be collected from this study will be managed only by the principal investigators (authors of this paper). The data will be saved on the university computer, protected by a password. The complete study timeline is presented in figure 1. Statistical analyses and data analyses plan The Shapiro-Wilk test will be used to test for normality of data. If the data are non-parametric, the normalisation will be performed by a math strategy. Student’s t-test for dependent variables will be used for inferential analyses. A p value <0.05 will be considered statistically significant. DdFTdS will perform all the statistical analyses. dIsCussIon Photobiomodulation has been extensively studied for wound healing in the medical literature, showing good results.33–35 The effect is related to the increased prolifer- ation of dermal fibroblasts, collagen synthesis, decrease of the inflammatory cells and formation of granulation tissue. The use of both LED and lasers has been consid- ered effective.36 37 Recently, some studies proposed the use of phototherapy in aesthetics protocols for rejuve- nation.15 38 However, it is still needed to optimise photo- therapy parameters such as energy and the number of sessions.39 Despite the fact that phototherapy has been proposed as an interesting tool to reduce wrinkles, clinical trials evalu- ating any real effects are sparse.11 40 41 On this subject, this study’s protocol was designed to evaluate the reduction of wrinkles when using red or amber LED devices. This current work has described a study protocol for a unicen- tric randomised clinical trial based on the comparison of the two interventions. The study has been designed to optimise the obtainment of results and to minimise bias. First, the participants will be their own control, since the measurements are going to be accomplished before and after a series of 10 sessions of interventions. Second, by performing a split-face study, this will eliminate the indi- vidual factors of each participant that affect treatment outcomes. Pre-existing systemic pathologies, personal daily care and food intake, together with smoking and drinking habits, may affect the results obtained, and performing both treatments on each patient will make these factors influence the results equally for the two groups. In addition, if the application of phototherapy generates some systemic effects, it will have the same influence on the results of the two treatments. This has been carefully considered, since some studies have shown systemic effects of phototherapy.42 43 Third, it is known that melanin absorbs light in the visible and infrared region of the spectra. Thus, the results of the application of both LED, in red and amber, may be affected by the melanin content of the skin. In this sense, skin types II, III and IV were chosen as inclusion criteria to standardise the melanin content of the participants, excluding skin types with high melanin content (types V and VI) and lower melanin content (type I). Fourth, a double-blind study will reduce errors of bias due to the subconscious influence of the volunteers as well as the researchers on data acquisition. Finally, this randomisation will be performed in an equal way (ie, group A=group B); then in case of a patient’s withdrawal after the first randomi- sation, new inscriptions and a new randomisation can be generated, thus allowing the researchers to reach the desired number of patients for the study. The aesthetics of the face may have positive or negative effects on the quality of life of patients, as well as on their self-esteem. Despite being treated as futilities, aesthetic treatments may have strong and important influences on psychological and emotional levels, as well as on the well-being of people. Some studies have already shown 4 Rocha Mota L, et al. BMJ Open 2018;8:e021419. doi:10.1136/bmjopen-2017-021419PDF Image | Efficacy of phototherapy to treat facial aging when using a red versus an amber LED
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