A Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A +/- High-Energy Visible Blue Light Exposure
NCT ID: NCT06654102
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2024-10-23
2024-11-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Regimen 1: Deep UVA
Deep UVA, 380-400nm, will be used for subsites 2 to 7 of Test Sites 1 and 2.
Deep UVA Irradiation
A timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 1 and 2 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes.
Regimen 2: Deep UVA + HEV Blue Light
Deep UVA + HEV Blue Light, 380-420 nm, will be used for subsites 2 to 7 of Test Sites 3 and 4
Deep UVA+HEV Blue Light Irradiation
A timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 3 and 4 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes.
Non-irradiated control
Subsite 1 in each test site (Test Sites 1-4) will be a non-irradiated control
No interventions assigned to this group
Interventions
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Deep UVA Irradiation
A timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 1 and 2 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes.
Deep UVA+HEV Blue Light Irradiation
A timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 3 and 4 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
60 Years
FEMALE
Yes
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Locations
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SGS Union Research Center, a Division of SGS North America, Inc.
Union City, New Jersey, United States
Countries
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Other Identifiers
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CS2024SK100175
Identifier Type: -
Identifier Source: org_study_id