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► With thyroid disorders (hyperthyroidism or hypothy- roidism) and who are not undertaking the due treat- ment, or those who have been taking the medications for less than 1 year. ► Who have received a facial filling in the last 12 months. ► Who are doing any facial aesthetic procedure. ► Who are using retinoic acid or any vitamin A deriva- tive (tretinoin or isotretinoin, topical or oral). ► Who are using cosmetics or medications that may increase the photosensitivity of the skin. ► Who present any pathology of the skin, such as acne, psoriasis, vitiligo and so forth. ► Who present big laterality of skin ageing. ► Professional drivers. ► Who have undergone bariatric surgery or who are confined to a strict diet. ► Who are using any supplement (topic or oral) for the improvement of their skin condition. ► Who are pregnant or lactating. ► Who are not regular attendees of treatments. sample size calculation A pilot study with 10 patients was performed to generate the data for the sample size calculation. All of the partici- pants of this pilot study signed the informed consent form. The largest and the smallest values of the percentages of reduction in the volume of the wrinkles for each treat- ment were obtained, as well as for the Standard deviation (SD) of the measurements. The worst-case scenarios were used for this calculation. The smallest and the largest values were 95 and 5, respectively; the highest SD was 29 and the number of treatment groups was 2. These values were used for the calculation of the effect size, as follows: largest−smallest 95−5 ∆= (σ )2 =(29)2 =0.214 √n √2 By using the effect size value as calculated above, t-tests were used to evaluate the differences between the two dependent means (matched pairs); the test power was 80% and the one-tailed test was at 5%; and the sample size calculated by the G*Power software (V.3.1.9.2, Dussel- dorf, Germany) was 137. randomisation The equal randomisation will be performed by a researcher (ACRTH) who is not directly involved in the treatment of the participants. It will be generated on Excel 2013 software (Microsoft, USA). The opaque envelopes will be marked and identified by sequential numbers, and each envelope will have a paper containing the information on which particular treatment will be performed on the right hemiface of the participant, in accordance with the draw. These envelopes will be sealed and securely stored in a safe place, with utmost confidentiality, by the same researcher who generated the randomisation. Immedi- ately before the treatments, the researcher responsible for the treatment will receive the envelope, in sequence, and will then perform the indicated procedure. Interventions All of the participants will have their faces cleaned with a neutral cleansing soap and receive eye protection, followed by the LED application. The participants will have their eyes protected by goggles, in order to safely allow the illumination of their periocular region. This will also make the study blind, so that they do not know which wavelength is being applied to each hemiface. The application of phototherapy and the measurement of the parameters will be performed by ICSSR. Thus, this protocol will be a double-blind study. All of the participants will receive photobiomodula- tion to treat their periocular wrinkles, using red and amber LEDs, with one colour only at each hemiface. The facial side to be treated with each different colour will be randomised. Group A will receive a red LED on the right side of their face and an amber LED on the left side of their face; group B will receive a red LED on the left side of their face and an amber LED on the right side of their face. For both of the groups, the session will last for 10min (3.8J/cm2 at each wavelength), and the complete treatment will be composed of 10 sessions, 2–3 sessions per week, within 1 month. After a period of 180 days, the cross-over treatment will be performed: the participants in group A will receive the application of an amber LED on their right hemiface and a red LED on their left hemi- face, while group B participants will receive a treatment with a red LED on their right hemiface and an amber LED on their left hemiface. As performed in the first part of the study, both of the groups will have 10min of exposure per session (5.4J/cm2 at each wavelength), with a complete treatment of 10 sessions, performed 2–3 sessions per week, within 1month. All of the variables will be measured before and after a group of 10 sessions. This procedure will be conducted for each hemiface. This second group of data can inform if the effects of the first treatment would disappear after the washout period and if the clinical response to the second treatment would be different from the first one. The participants may not receive any other facial aesthetic procedure or any supplement (topic or oral) for the improvement of their skin condition during the development of this study. Variables of the study The primary outcome of the study is the volume of wrin- kles in the periocular region. The secondary outcomes are elasticity/sagging, hydration, melanin/spots, quality of life and self-assessment by the participants. Volume of wrinkles in the periocular region and the melanin spots For measurements of the primary variable, VisioFace RD (CK Electronic, Cologne, Germany) equipment will be used. This apparatus has a digital camera with white diode illumination that will record a standardised photo- graph of each participant’s face. Through a computer program, parameters will be determined that will indicate the volume of wrinkles in the periocular region, which is commonly known as crow’s feet. Open Access Rocha Mota L, et al. BMJ Open 2018;8:e021419. doi:10.1136/bmjopen-2017-021419 3PDF Image | Efficacy of phototherapy to treat facial aging when using a red versus an amber LED
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