Twice a week, for 20 minutes, participants will undergo exposure to blue, red, and infrared light as part of the light therapy treatment.

• Comprehensive Weekly Skin Health Self-Assessment: Conducted weekly.
• Dermatology Life Quality Index (DLQI): Conducted during the study.
• Facial Skin Self-Assessment Survey: Conducted during the study.
• Pre/Post Photos of Participants’ Skin: Conducted at the beginning and end of the study.

The study entitled "See the Impact Beem's Blue Light Therapy Has on Your Skin Health!" aims to evaluate the effectiveness of a light therapy regimen on improving skin health. This single-arm observational trial, conducted under Efforia's Signal Phase study design, involves participants undergoing a twice-weekly, 20-minute light therapy session. Each session is structured into three phases: starting with blue light, transitioning to red light, and concluding with infrared light, each targeting different aspects of skin health. By allowing participants to act as their own control, the trial will provide initial insights into the potential benefits of this therapy for enhancing skin appearance and health, with a focus on gathering preliminary efficacy and safety data.

The study's methodology is designed to assess how these light therapies influence skin conditions through a series of personalized assessments and feedback mechanisms. Participants will engage in various self-assessment tasks, including a Comprehensive Weekly Skin Health Self-Assessment, Dermatology Life Quality Index (DLQI) surveys, and Facial Skin Self-Assessment Surveys. These tasks are complemented by pre- and post-therapy photographic documentation to visually track skin changes. By collecting this data, the trial seeks to discern patterns and indications of improvement in skin health, potentially providing a directional indication of positive results from the intervention.

Should the trial demonstrate a positive signal suggesting the effectiveness of the light therapy, it will pave the way for more rigorous study designs in the future. The current study also aims to compile a more comprehensive safety profile for the intervention, addressing the current lack of robust data in this area. Participants' adherence to study protocols, including maintaining consistent skincare routines and promptly reporting any health concerns, is crucial for ensuring the validity and reliability of the study's findings. For further details on study protocols and participant guidelines, refer to the Minimal Risk Umbrella protocol.

The statistical plan for this study aligns with the Minimal Risk Umbrella protocol, ensuring that we adhere to the established guidelines for studies that involve minimal risk to participants. The study design incorporates validated measures and surveys to assess various dimensions of skin health and participant expectations, allowing for a comprehensive evaluation of the effects of Beem’s Blue Light Therapy on skin health.

To maintain consistency with the Minimal Risk Umbrella protocol, we have integrated a statistical approach that emphasizes the safety and well-being of participants while ensuring robust data analysis. This approach includes descriptive statistics to summarize baseline characteristics and outcome measures, as well as inferential statistics to assess changes over time and the potential impact of the intervention.

For reviewers interested in evaluating the details of our statistical plan, we recommend consulting the statistical section within the Minimal Risk Umbrella protocol. This section provides a thorough overview of the methodologies and analytical techniques approved for use in minimal risk studies, ensuring that our approach is compliant and methodologically sound.

By adhering to the guidelines outlined in the umbrella protocol, we aim to maintain the integrity and ethical standards expected in clinical research, while providing meaningful insights into the potential benefits of light therapy on skin health.

This single-arm observational trial, conducted under the Minimal Risk Citizen Science Umbrella Protocol, aims to evaluate the potential benefits of Blue Light Therapy—a combination of blue, red, and infrared wavelengths—on skin health and clarity. While the absence of a control group is a significant limitation that could introduce bias, efforts have been made to mitigate this through an expectations questionnaire. By assessing participant expectations, we aim to quantify potential biases and better understand how these perceptions might influence reported outcomes. This approach helps ensure that any changes in skin appearance and vitality are not solely attributed to participant enthusiasm or placebo effects.

Another limitation of our study is the relatively small sample size, which may affect the generalizability of the findings. To address this, our statistical methodology incorporates stratification by participant demographics, such as age and baseline skin condition, allowing us to analyze data more precisely. This stratification helps identify trends and patterns that may inform future, larger-scale studies. As a signal detection study, the primary objective is to identify preliminary efficacy signals, such as improvements in skin clarity or healing. Positive initial findings will pave the way for subsequent research employing more controlled and rigorous designs to validate these results.

The overarching goal of Efforia and the Minimal Risk Umbrella Protocol is to democratize clinical research, particularly by supporting exploratory research questions that might otherwise be overlooked. In this context, our study contributes to the burgeoning field of light therapy by generating valuable preliminary data. By involving participants directly in a minimally invasive study, we enable them to gain personalized insights into their skin health while contributing to a broader understanding of the potential benefits of light therapy. Participants are encouraged to refer to the Minimal Risk Umbrella Protocol for further information on the methodological framework underpinning this study.