A Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A +/- High-Energy Visible Blue Light Exposure
- Conditions
- Skin PigmentationPhotobiology
- Registration Number
- NCT06654102
- Lead Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Brief Summary
The objective of this study is to assess the level of pigmentation following an acute exposure of skin to light regimens representative of portions of the natural sunlight spectrum and that contain Deep UVA wavelengths with or without HEV Blue Light, as compared to non-irradiated control skin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 18
- Uniform skin color over the whole test area (the lower back) with minimal variation between test sites.
- At least 3 subjects per skin type, as defined by self-reported reaction to sun exposure and Chromameter measurements.
- Generally in good health.
- Able to read, write, speak, and understand English.
- Intends to complete the study and is willing and able to follow the subject responsibilities.
- In another study without approval by the study site.
- Has known allergies or negative reactions to common topical skincare products or UV light.
- Has a history of abnormal responses to sunlight or UV radiation.
- Has used a tanning bed/lamp, has had extended sun exposure of the test area, or has participated in a UV exposure study within the past 4 weeks.
- Has a current illness/condition/situation, a medical history of a disease/condition, or a skin condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, etc.) that could confuse the study results, interfere with participation, or increase health risk to the subject, as determined by the study investigator.
- Has shaved/waxed the test area within 2 weeks before Visit 1.
- Has used any products in the test area within 24 hours before Visit 1.
- Has sunburn, suntan, scars, tattoos, active dermal lesions, nevi, or other conditions in the test area that could confuse the study results or increase health risk to the subject, as determined by the study investigator.
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
- Is immunosuppressed (such as HIV-positive, transplant patients, undergoing chemotherapy or radiotherapy, etc.).
- Has been using a product or medication that the study investigator determines will increase health risk to the subject or confuse the study results
- Has a personal or family history of skin cancer.
- Skeletal protrusions and/or extreme areas of curvature in the test area.
- Is pregnant, nursing, or planning to become pregnant.
- Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pigmentation level as determined by clinical evaluation 15 mins and 18-22 hours Post-Irradiation The subsites of each test site will be graded for immediate or persistent pigmentation darkening (IPD/PPD) by a trained evaluator using a 0-2 grading scale, where 0 = no pigmentation darkening and 2 = moderate to intense pigmentation darkening.The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2.
- Secondary Outcome Measures
Name Time Method Pigmentation response as quantified by imaging Baseline, 15 mins and 18-22 hours Post-Irradiation Images of each test site will be analyzed to quantify the level of pigmentation using L\* and b\* color space values, where an increase in pigmentation corresponds to a decrease in L\* values and a potential decrease in b\* values or increase in a\* values. Change from baseline will be calculated. The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2.
Pigmentation response as quantified by Chromameter Baseline, 15 mins and 18-22 hours Post-Irradiation A Chromameter will be used to quantify the level of pigmentation of subsites 1 and 7 using L\* and b\* color space values, where an increase in pigmentation corresponds to a decrease in L\* values and a potential decrease in b\* values or increase in a\* values. Change from baseline will be calculated. The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2.
Trial Locations
- Locations (1)
SGS Union Research Center, a Division of SGS North America, Inc.
🇺🇸Union City, New Jersey, United States