Visible Light Study

NCT ID: NCT02663921

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-04-17

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.

Conditions

Skin Disease; Pigment Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Healthy volunteers without cutaneous disorders associated with pigmentary changes

Group Type: EXPERIMENTAL

Part A: Baseline-Week 2

Intervention Type: 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:

1. Immediately after the light exposure;

2. 30 minutes after light exposure; and

3. 1 hour after light exposure.

Part B: Week 4-Week 12

Intervention Type: 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

1. Visual Clinical Assessment

2. Spectroscopy

3. Colorimetry

Interventions

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:

1. Immediately after the light exposure;

2. 30 minutes after light exposure; and

3. 1 hour after light exposure.

Intervention Type: OTHER

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

1. Visual Clinical Assessment

2. Spectroscopy

3. Colorimetry

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Soter

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

14-02039

Identifier Type: -

Identifier Source: org_study_id