Visible Light Study

NCT02663921 | Completed

• 1 other identifier: 14-02039
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about the potential effects of visible light on the skin. More specifically, this study will examine whether an incandescent lamp (light bulb) or LED light bulb can cause skin to become darker. Investigators will determine the minimum threshold dose required to achieve immediate pigmentation darkening (IPD), persistent pigmentation darkening (PPD), and delayed tanning (DT) for Fitzpatrick skin types IV - VI utilizing two visible light sources.

Conditions

Skin Disease; Pigment Disorders

Keywords

Fitzpatrick Skin-Type; Melanin; Ultraviolet Light (UV)

Outcome Measures

Primary Outcomes (5)

• Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin

  12 weeks

• Quantification of the scattering and absorption properties of the skin in which the beam of light will penetrate using DRS

  12 weeks

• Measurement of pigmentation changes induced by the two light sources using diffuse reflectance spectrometer

  12 weeks

• Measurement of pigmentation changes induced by the two light sources using Colorimetry

  12 weeks

• Measurement of pigmentation changes induced by the two light sources using Cross-Polarized Digital Photography

  12 weeks

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Healthy volunteers without cutaneous disorders associated with pigmentary changes

Other: Part A: Baseline-Week 2; Other: Part B: Week 4-Week 12

Interventions

Part A: Baseline-Week 2 OTHER

The study doctor will shine 2 different light bulbs (one a regular or incandescent bulb and the other an LED light bulb) on 12 different areas of patients skin approximately 6 square centimeters in size (less than 1 square inch or the size of your thumb nail). Each light bulb will be exposed to your skin for approximately 20 - 35 minutes. After exposure, the study doctor will perform skin assessments at 3 time points: 1. Immediately after the light exposure; 2. 30 minutes after light exposure; and 3. 1 hour after light exposure.

Healthy volunteers

Part B: Week 4-Week 12 OTHER

The study doctor will perform the same 4 skin assessments used in Part A at each visit to assess potential changes in your skin: Digital Photography 1. Visual Clinical Assessment 2. Spectroscopy 3. Colorimetry

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a healthy volunteer with Fitzpatrick skin types I-VI;
• Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection;
• Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
• Agree to follow and undergo all study-related procedures.

You may not qualify if:

• Women who are lactating, pregnant, or planning to become pregnant;
• Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post-inflammatory hyperpigmentation;
• Patients with a known history of photosensitivity disorders;
• Photosensitizing medications may be continued throughout of the study at the discretion of the investigator ;
• Patients with a known history of melanoma or non-melanoma skin cancers;
• Concomitant use of tanning beds;
• Sun exposure of the irradiated or control areas;
• Patients with serious systemic disease.
• Patients with a known history of hypersensitivity to adhesives including adhesive tape.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Skin Diseases; Pigmentation Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicholas Soter

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 26, 2016
• Study Start: September 1, 2015
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: June 17, 2019

Record last verified: 2019-06

Locations

US (1)