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Visible Light Study

Primary Purpose

Skin Disease, Pigment Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Part A: Baseline-Week 2
Part B: Week 4-Week 12
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin Disease focused on measuring Fitzpatrick Skin-Type, Melanin, Ultraviolet Light (UV)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy volunteers

Arm Description

Healthy volunteers without cutaneous disorders associated with pigmentary changes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 21, 2016
Last Updated
June 13, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02663921
Brief Title
Visible Light Study
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
April 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Disease, Pigment Disorders
Keywords
Fitzpatrick Skin-Type, Melanin, Ultraviolet Light (UV)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Healthy volunteers without cutaneous disorders associated with pigmentary changes
Intervention Type
Other
Intervention Name(s)
Part A: Baseline-Week 2
Intervention Description
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: Immediately after the light exposure; 30 minutes after light exposure; and 1 hour after light exposure.
Intervention Type
Other
Intervention Name(s)
Part B: Week 4-Week 12
Intervention Description
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 Visual Clinical Assessment Spectroscopy Colorimetry
Primary Outcome Measure Information:
Title
Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin
Time Frame
12 weeks
Title
Quantification of the scattering and absorption properties of the skin in which the beam of light will penetrate using DRS
Time Frame
12 weeks
Title
Measurement of pigmentation changes induced by the two light sources using diffuse reflectance spectrometer
Time Frame
12 weeks
Title
Measurement of pigmentation changes induced by the two light sources using Colorimetry
Time Frame
12 weeks
Title
Measurement of pigmentation changes induced by the two light sources using Cross-Polarized Digital Photography
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Soter
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Visible Light Study

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