A Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A +/- High-Energy Visible Blue Light Exposure

Johnson & Johnson (J&J)

Status: Completed

Conditions: Photobiology; Skin Pigmentation

Treatments: Other: Deep UVA+HEV Blue Light Irradiation; Other: Deep UVA Irradiation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06654102

CS2024SK100175

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Regimen 1: Deep UVA

Experimental group

Description:

Deep UVA, 380-400nm, will be used for subsites 2 to 7 of Test Sites 1 and 2.

Treatment:

Other: Deep UVA Irradiation

Regimen 2: Deep UVA + HEV Blue Light

Experimental group

Description:

Deep UVA + HEV Blue Light, 380-420 nm, will be used for subsites 2 to 7 of Test Sites 3 and 4

Treatment:

Other: Deep UVA+HEV Blue Light Irradiation

Non-irradiated control

No Intervention group

Description:

Subsite 1 in each test site (Test Sites 1-4) will be a non-irradiated control