This article presents a detailed protocol for a randomized controlled trial that aims to investigate the efficacy of phototherapy in reducing periocular wrinkles using red and amber LED lights. The study focuses on the aging process of the skin, particularly the effects of intrinsic and extrinsic factors, including solar radiation, on cellular aging and skin aging.
The skin undergoes morphological and physiological changes as an individual ages, leading to various signs of aging, including increased skin flaccidity, thickening, hyperpigmentation, wrinkles, and even skin cancer. To address these issues, numerous treatments have been developed, and one promising approach is phototherapy using light-emitting diodes (LEDs).
The primary objective of this study is to evaluate the reduction in the volume of periocular wrinkles (crow's feet) when treated with red and amber LEDs. The study will be conducted as a controlled, randomized, double-blind, split-face, cross-over, and unicentric clinical trial. The participants, women aged 40-65 with specific skin phototypes and severity of wrinkles, will undergo photobiomodulation treatment using either red or amber LEDs on different sides of their face.
The treatment sessions will be conducted over a period of one month, with 10 sessions performed at 2-3 sessions per week. The primary outcome measure will be the volume of wrinkles in the periocular region, which will be assessed using a specialized imaging system called VisioFace RD. Secondary outcome measures include skin elasticity/sagging (evaluated using Cutometer Dual MPA 580), skin hydration (measured with Corneometer CM 825), melanin spots, quality of life, and self-assessment by the participants.
To ensure rigorous methodology and minimize bias, several measures have been implemented. Participants will act as their own controls, as measurements will be taken before and after the treatment sessions. Additionally, a split-face design will eliminate individual factors that may influence treatment outcomes. The study will also be conducted in a double-blind manner, with the researchers and participants unaware of which wavelength (red or amber) is being applied to each side of the face.
The article discusses the rationale behind the choice of red and amber wavelengths based on previous studies that have demonstrated their effects on cellular activity, collagen expression, and skin regeneration. The study also addresses potential confounding factors, such as participants' habits, skin characteristics, and the influence of melanin content on the results.
The sample size calculation was performed based on a pilot study, and randomization will be achieved using opaque envelopes marked with sequential numbers. The study will adhere to ethical guidelines, and data collection and analysis will be performed by trained researchers using validated instruments and questionnaires.
The protocol emphasizes the importance of phototherapy as a non-invasive and potentially effective treatment for reducing wrinkles and improving skin appearance. The results of this study may contribute to the development of optimized treatment protocols for aesthetic rejuvenation and provide valuable insights into the comparative efficacy of red and amber LED lights.
Once the study is completed, the data will be analyzed, and the results will be disseminated through conferences and peer-reviewed publications. The article concludes by acknowledging the contributions of individuals and organizations involved in the research, highlighting the importance of collaboration and access to specialized equipment for non-invasive skin analysis.
Authors and Affiliations
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.
https://bmjopen.bmj.com/content/8/5/e021419