- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07298382
See the Impact Beem's Blue Light Therapy Has on Your Skin Health!
Study Overview
Detailed Description
Treatment activities:
Twice a week, for 20 minutes, participants will undergo exposure to blue, red, and infrared light as part of the light therapy treatment.
Assesments and frequency:
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.
Methodology:
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthew Amsden
- Phone Number: (646) 679-2479
- Email: help@efforia.com
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Recruiting
- Efforia
-
Contact:
- Matthew Amsden
- Phone Number: (646) 679-2479
- Email: help@efforia.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Exclusion Criteria:
- Individuals with Epilepsy
- Individuals with Photosensitivity
- Individuals with eye conditions
- Pregnant individuals
- Individuals with skin sensitivity
- Individuals taking certain light-sensitive medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Arm longitudinal where participants act as their own control
|
Blue Light Therapy therapy, combining blue, red, and infrared light, has been backed by studies showing improved skin health and reduced signs of aging. The medical community generally supports light therapy for its non-invasive nature and potential benefits, though results can vary. Social media buzz highlights glowing testimonials, while the general population views it as a promising skincare enhancement with minimal risks. Benefits include improved complexion and reduced acne, with risks being rare and minor, such as temporary redness. Treatment: First 5 Minutes 450nm (Blue) Second 5 Minutes 450nm (Blue) 660nm (Red) 810nm (Infrared) Final 10 Minutes 660nm (Red) 810nm (Infrared) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comprehensive Weekly Skin Health Self-Assessment
Time Frame: Baseline through Day 30 (weekly assessments)
|
The Comprehensive Weekly Skin Health Self-Assessment is designed to meticulously evaluate various aspects of skin health, including clarity, breakouts, pore size, redness, moisture, sensitivity, and signs of aging. This detailed survey allows individuals to track changes weekly, providing insights into the effectiveness of their skincare routines and the impact of lifestyle choices on their skin's condition. By regularly monitoring a wide range of skin health indicators, users can make informed adjustments to their skincare practices, aiming for optimal skin health. The survey fosters a proactive approach to skincare, emphasizing the importance of observation and adjustment based on personal skin behavior. Scoring scale 0-75 Interpretation Higher score is associated with better perceived skin health Lower score is associated with worse perceived skin health |
Baseline through Day 30 (weekly assessments)
|
|
Dermatology Life Quality Index (DLQI)
Time Frame: Baseline through Day 30 (weekly assessments)
|
The Dermatology Life Quality Index (DLQI) is a survey designed to measure the impact of skin-related issues on the quality of life over the past week. It assesses various dimensions of daily living, from personal discomfort to social interactions, influenced by skin conditions. This index is valuable for both patients and healthcare providers to understand the severity and emotional toll of dermatological issues. By quantifying the effects on daily activities and personal relationships, the DLQI helps in guiding treatment decisions and measuring treatment outcomes. Scoring Range Minimum score: 0 Maximum score: 30 Each of the 10 items is scored from 0 to 3, yielding a total score between 0 and 30. Score Interpretation Higher scores indicate worse outcomes, meaning a greater negative impact of skin disease on a participant's quality of life. |
Baseline through Day 30 (weekly assessments)
|
|
Facial Skin Self-Assessment Survey
Time Frame: Baseline through day 30 (weekly assessments)
|
The Comprehensive Weekly Skin Health Self-Assessment is designed to meticulously evaluate various aspects of skin health, including clarity, breakouts, pore size, redness, moisture, sensitivity, and signs of aging. This detailed survey allows individuals to track changes weekly, providing insights into the effectiveness of their skincare routines and the impact of lifestyle choices on their skin's condition. By regularly monitoring a wide range of skin health indicators, users can make informed adjustments to their skincare practices, aiming for optimal skin health. The survey fosters a proactive approach to skincare, emphasizing the importance of observation and adjustment based on personal skin behavior. Scoring scale 0-75 Interpretation Higher score is associated with better perceived skin health Lower score is associated with worse perceived skin health |
Baseline through day 30 (weekly assessments)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 46140
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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