Clinical trial NCT02663921: 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
Overall status: COMPLETED
Phase: NA
Conditions: Skin Disease
Pigment Disorders
Keywords: Fitzpatrick Skin-Type
Melanin
Ultraviolet Light (UV)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin
timeFrame: 12 weeks
measure: Quantification of the scattering and absorption properties of the skin in which the beam of light will penetrate using DRS
timeFrame: 12 weeks
measure: Measurement of pigmentation changes induced by the two light sources using diffuse reflectance spectrometer
timeFrame: 12 weeks
measure: Measurement of pigmentation changes induced by the two light sources using Colorimetry
timeFrame: 12 weeks
measure: Measurement of pigmentation changes induced by the two light sources using Cross-Polarized Digital Photography
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Nicholas Soter
role: PRINCIPAL_INVESTIGATOR
References: