Visible Light Study

Study Overview
=================
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.

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.

Conditions
-----------------
Skin Disease, Pigment Disorders

Intervention / Treatment
-----------------
* Other: Part A: Baseline-Week 2
* Other: Part B: Week 4-Week 12


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br>Healthy volunteers without cutaneous disorders associated with pigmentary changes | Other: Part A: Baseline-Week 2<br>* 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.<br>Other: Part B: Week 4-Week 12<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fitzpatrick Skin-Type, Melanin, Ultraviolet Light (UV)