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Open Access improvements in the quality of life and self-assessments by patients after aesthetic treatments.44 45 In this sense, the aforesaid questionnaires will be used to evaluate these aesthetic effects. Since the quality of life and the self-assess- ment questionnaires that have been validated in Portu- guese when related to wrinkles are sparse, we decided to make fairly minor adaptations on some previously validated ones. The adaptation of the quality of life questionnaire for participants with dermatological diseases (Skindex-29)30 has involved the removal of 10 questions related to skin diseases that are not suitable for participants with wrinkles, resulting in a new questionnaire with 19 questions. The adaptation of the quality of life questionnaire for partici- pants with melasma (MelasQoL-BP)31 has included the substitution of the word ‘melasma’ by the word wrinkles. Due to these adaptations, the questionnaires will be evalu- ated in terms of reproducibility and internal consistency, as has been previously performed on other questionnaires.46 When considering the importance of aesthetics of the face on the life role of a person, the development of efficacious treatments is essential. However, to prove that a treatment presents efficacy, the choice of a quantitative evaluation method is challenging. Most of the trials evaluating facial skin that can be found in the literature are based on subjec- tive measurements (patient satisfaction and photos), since quantitative studies use biopsies.40 41 47 For this research, non-invasive quantification methods will be used aimed at evaluating a group of variables that may be affected or improved by photobiomodulation therapy (volume of wrin- kles, elasticity/sagging and hydration). Treatment and eval- uation procedures during this study will be performed by beauticians, since the procedures are non-invasive and they are included in beauticians’ professional attributions. In case the participants present any complication, IdSD will evaluate the participant and guide the treatment. Some studies have pointed to the efficacy of LEDs in tissue repair, cutaneous hydration and increase in the production of the sustentation fibres. However, there are still studies that standardise dosimetry and the parameters of use.48 49 Here, the choice of wavelengths was made from studies that had demonstrated that an application of red light on the skin could trigger cell proliferation, increased collagen fibres and decreased metalloproteinases; these studies had also demonstrated that an amber light can interact with the epidermal cells, triggering mitosis and cell renewal, as well as acting on the protection and the hydration of the epidermis; all of this information is, together with clinical trials, showing an improvement of wrinkles using photo- therapy.11 15 22 41 50 There is no consensus in the literature regarding the washout period for phototherapy, which varies from 7 days to 12 weeks.51–54 Due to this, a washout of 180 days for performing the cross-over treatment was chosen to evaluate if there were any residual effects from the first photobiomodulation treatment performed. The results of this clinical trial may confirm the effica- ciousness of phototherapy in reducing periocular wrin- kles and show improvements in certain other parameters. Besides, the comparison between the reduction of wrinkles achieved by each wavelength may be a valuable contribu- tion to the aesthetics area and pave the way to developing new treatment protocols with satisfactory results. EthICs And dIssEMInAtIon This protocol was approved by the Research Ethics Committee of the Nove de Julho University (acceptance number: 2.550.732). The trial has already been registered in the Registro Brasileiro de Ensaios Clínicos (REBEC number: RBR-6YFCBM) and it grants public access to the full protocol. After publishing the protocol, the data will be collected and the results will be presented at confer- ences and published in a peer-reviewed journal, selected by interest area and impact factor. At the end of the study, the main results will be disseminated to participants by email. The authorship of the results paper will include the authors of the protocol and others who may contribute to the procedures or analysis of data. Acknowledgements The authors thank Ieda Cristina Silva Santos Rocha (ICSSR), who performed the treatments, Cosmedical (Mauá, Brazil) which kindly provided the LED device, Lineallux to be used in this research, and Tecnotests (São Paulo, Brazil), the CK Electronic representative in Brazil, which kindly provided the devices for non-invasive analysis of the skin. Contributors LRM wrote the protocol and will execute the measurements. LJM adapted the QoL and the self-assessment questionnaires and will perform the reproducibility and internal consistency analysis, and LRM will apply them to the participants. IdSD designed the protocol and will evaluate the participants using the inclusion/exclusion criteria. DdFTdS performed the sample size calculation, proposed the statistics and will analyse the data. ACRTH generated the randomisation and designed the study. CP conceived and designed the treatment protocol. All of the authors have read and approved the final version of the protocol and of the manuscript. Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Competing interests None declared. Patient consent Not required. Ethics approval This protocol was approved by the Research Ethics Committee of the Nove de Julho University on 22 June 2017 (#2.134.166) and the amendment with 137 patients on 19 March 2018 (#2.550.732). Provenance and peer review Not commissioned; externally peer reviewed. open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/ licenses/by-nc/4.0/ © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. rEFErEnCEs 1. Mukherjee S, Date A, Patravale V, et al. Retinoids in the treatment of skin aging: an overview of clinical efficacy and safety. Clin Interv Aging 2006;1:327–48. 2. Mukherjee PK, Maity N, Nema NK, et al. Bioactive compounds from natural resources against skin aging. Phytomedicine 2011;19:64–73. 3. Boyd AS, Naylor M, Cameron GS, et al. The effects of chronic sunscreen use on the histologic changes of dermatoheliosis. J Am Acad Dermatol 1995;33:941–6. 4. Fourtanier A, Moyal D, Seité S. Sunscreens containing the broad- spectrum UVA absorber, Mexoryl SX, prevent the cutaneous 6 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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