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. The skin covers the body and has essential functions in maintaining the homeostasis of an organism, presenting roles such as defence, thermoregulation and sensory awareness. Maintenance of healthy skin and integrity is extremely important. Exposure to the sun speeds up the intrinsic ageing of the skin, due to the formation of free radicals and reactive oxygen species, as a result of ultraviolet (UV) radiation. Once UVA radiation 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. The changes that are caused by ageing modify the physical properties of the skin, leaving visible signs such as epidermal hyperplasia, irregular pigmentation, telangiectasia, sagging tissues, a reduction 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.
Recent data from the Brazilian Institute of Geography and Statistics (IBGE) have shown that the average life expectancy of the Brazilian population has increased from 66 years in 1991 to 75 years in 2016. This is similar to the increase that has been verified on worldwide population. The challenge faced by science in the last few years has been the development of procedures and technologies that aim to delay the signs of ageing and increase the quality of life of elderly people, by achieving a healthy skin. Nowadays, the procedures in use aim to promote a cosmetic benefit and an improvement in the quality of the skin, increasing self-esteem, with a reduction in skin infections. As a result, these procedures can contribute to a longer and healthier life. Among the technologies being used to promote skin repair are dermocosmetics, as well as equipment such as radiofrequency, phototherapy (intense pulsed light, laser and light-emitting diodes (LEDs)) and microneedles.
Phototherapy is a non-invasive procedure that has been used for tissue repair and healing. The treatment is based on the use of a light-emitting device, and the resulting photons are absorbed by the biological tissues, promoting photochemical, photophysical and photobiological actions. Phototherapy is not ablative, nor does it promote thermal effects, since the devices that are used in phototherapy are low-powered lasers and LEDs; that is, there is no cutaneous damage and no need for any recovery time.The LED devices are produced in a wide range of wavelengths, from UV through the visible to infrared spectrum (247–1300 nm). When compared with laser, the LED devices have lower cost and have being used in instruments that can illuminate larger surfaces. Studies have shown that LEDs can be used in therapeutic procedures with excellent results. The use of LEDs in clinical practice has increased significantly, and their main use has been in wound healing, tissue repair and rejuvenation since they do not cause trauma or tissue destruction. Some findings have suggested that if suitable parameters are used, the light acts on skin regeneration by modulating cellular activity and collagen expression, with a decrease in matrix metalloproteinases. Usually, the wavelengths are chosen by the function that is needed for the purpose of the therapy. The wavelengths in the blue range (400–470 nm) are mainly used in the treatment of acne. The wavelengths in the green range (500–570 nm) have shown their ability to induce proliferation of fibroblasts, as well as production and maturation of the collagen fibres. The infrared range (700–1200 nm) accelerates the healing process of lesions in the skin, increases proliferation of cell differentiation, as well as contributes to an increase in the extracellular matrix. Many in vitro, in vivo and clinical studies have demonstrated the anti-inflammatory, repair, skin rejuvenation and healing effects that are promoted by red light. For an amber light, a study that was published by Smith in 2005 showed that it is absorbed by keratinocytes, melanocytes, as well as for the cells of Merkel and Langerhans, which are all of extreme importance in the maintenance of the epidermis. Both of these wavelengths are absorbed by cytochrome c oxidase; however, it is considered that the red light penetrates deeper into the skin than the amber light due to the presence of melanin. Given this background, this work will aim to evaluate the percentages of reduction in the volume of periocular wrinkles when treated with red and amber LEDs.
Methods and Analysis: This will be a controlled, randomised, double-blind, split-face, cross-over and unicentric clinical trial. This protocol has been written based on the guidelines of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). The study will be performed in the ambulatory of the Nove de Julho University (UNINOVE), São Paulo, Brazil. Dissemination and registration for participation in the study will be conducted through the UNINOVE website, and the recruited participants will mainly be residents of the city of São Paulo. The participants will be informed about the research, procedures, risks and benefits, and they will sign the informed consent form. Only those participants who have read and have agreed to sign the informed consent form will be included in the study. The study will last for 2 years, with a start date of May 2018. The study is not recruiting yet.
After recruitment, the researcher will check if the patient meets the inclusion/exclusion criteria based on anamnesis and skin evaluation. Anamnesis is an interview performed by the health professional to know patients’ medical and aesthetics treatment history, as well as daily personal and social habits, which may have an influence on treatment outcome. Regarding the daily personal and social habits, anamnesis will include information on sun exposure, smoking and drinking frequency, sleep quality, dietary habits, water intake, professional aesthetics treatment on the face and homecare cosmetics use. Anamnesis was not validated since it is not an instrument to measure patient outcome. Skin evaluation, which will be performed by a medical doctor (IdSD), includes skin phototype and degree of severity of the wrinkles. Patients will receive information on the importance of the use of sunscreen on skin health, preventing skin cancer and wrinkles.
Resources: BMJ journal,