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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Healthy volunteers
Healthy volunteers without cutaneous disorders associated with pigmentary changes
Intervention: Part A: Baseline-Week 2 (Other)
Healthy volunteers
Healthy volunteers without cutaneous disorders associated with pigmentary changes
Intervention: Part B: Week 4-Week 12 (Other)
Outcomes
Primary Outcomes
Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin
Time Frame: 12 weeks
Measurement of pigmentation changes induced by the two light sources using Cross-Polarized Digital Photography
Time Frame: 12 weeks
Quantification of the scattering and absorption properties of the skin in which the beam of light will penetrate using DRS
Time Frame: 12 weeks
Measurement of pigmentation changes induced by the two light sources using Colorimetry
Time Frame: 12 weeks
Measurement of pigmentation changes induced by the two light sources using diffuse reflectance spectrometer
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported