Visible Light Study

Skin Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663921
• Other study ID #: 14-02039
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: April 17, 2019

Study information

• Verified date: June 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pigment Disorders
• Pigmentation Disorders
• Skin Disease
• Skin Diseases

Intervention

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: Immediately after the light exposure; 30 minutes after light exposure; and 1 hour after light exposure.
• 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 Visual Clinical Assessment Spectroscopy Colorimetry

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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