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

NCT06654102 | Completed

• 1 other identifier: CS2024SK100175
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Pigmentation; Photobiology

Keywords

Skin Pigmentation; Photobiology

Outcome Measures

Primary Outcomes (1)

• Pigmentation level as determined by clinical evaluation

  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.

  15 mins and 18-22 hours Post-Irradiation

Secondary Outcomes (2)

• Pigmentation response as quantified by imaging

  Baseline, 15 mins and 18-22 hours Post-Irradiation

• Pigmentation response as quantified by Chromameter

  Baseline, 15 mins and 18-22 hours Post-Irradiation

Study Arms (3)

Regimen 1: Deep UVA

EXPERIMENTAL

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

Other: Deep UVA Irradiation

Regimen 2: Deep UVA + HEV Blue Light

EXPERIMENTAL

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

Other: Deep UVA+HEV Blue Light Irradiation

Non-irradiated control

NO INTERVENTION

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

Interventions

Deep UVA Irradiation OTHER

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 1: Deep UVA

Deep UVA+HEV Blue Light Irradiation OTHER

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.

Regimen 2: Deep UVA + HEV Blue Light

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

SGS Union Research Center, a Division of SGS North America, Inc.

Union City, New Jersey, 07083, United States

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4 test sites will be defined on the subjects' backs. Each test site will contain 7 subsites

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: October 23, 2024
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)