Clinical trial NCT06654102: A Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A +/- High-Energy Visible Blue Light Exposure
Official title: A Controlled, Single Center Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A (UVA) +/- High-Energy Visible (HEV) Blue Light Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Pigmentation
Photobiology
Keywords: Skin Pigmentation
Photobiology
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 test sites will be defined on the subjects' backs. Each test site will contain 7 subsites
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pigmentation level as determined by clinical evaluation
timeFrame: 15 mins and 18-22 hours Post-Irradiation
Secondary outcomes:
measure: Pigmentation response as quantified by imaging
timeFrame: Baseline, 15 mins and 18-22 hours Post-Irradiation
measure: Pigmentation response as quantified by Chromameter
timeFrame: Baseline, 15 mins and 18-22 hours Post-Irradiation
Other outcomes:
Locations:
city: Union City
country: United States
facility: SGS Union Research Center, a Division of SGS North America, Inc.
state: New Jersey
Study officials:
References: