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Completed

NCT Number: NCT02663921

Visible Light Study

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.

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Key information

Conditions

Skin Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Pigment Disorders Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • Immediately after the light exposure;
  • 30 minutes after light exposure; and
  • 1 hour after light exposure.

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

  • Visual Clinical Assessment
  • Spectroscopy
  • Colorimetry

Primary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2016
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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