Visible Light Study

June 13, 2019 updated by: NYU Langone Health

Determination of the Minimal Dose of Visible Light Required to Achieve Immediate Pigment Darkening, Persistent Pigment Darkening, and Delayed Tanning for Fitzpatrick Skin Types IV-VI Utilizing Two Visible Light Sources.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Healthy volunteers without cutaneous disorders associated with pigmentary changes
Other: Part A: Baseline-Week 2

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.
Other: Part B: Week 4-Week 12

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin
Time Frame: 12 weeks
12 weeks
Quantification of the scattering and absorption properties of the skin in which the beam of light will penetrate using DRS
Time Frame: 12 weeks
12 weeks
Measurement of pigmentation changes induced by the two light sources using diffuse reflectance spectrometer
Time Frame: 12 weeks
12 weeks
Measurement of pigmentation changes induced by the two light sources using Colorimetry
Time Frame: 12 weeks
12 weeks
Measurement of pigmentation changes induced by the two light sources using Cross-Polarized Digital Photography
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Nicholas Soter, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

April 17, 2019

Study Completion (Actual)

April 17, 2019

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

June 17, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-02039

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Disease

Clinical Trials on Part A: Baseline-Week 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe