Skin DiseaseNCT02663921
Visible Light Study
A study testing Part A: Baseline-Week 2 and Part B: Week 4-Week 12 in people with Skin Disease and Pigment Disorders, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Disease, Pigment Disorders
- What is being tested?
- Part A: Baseline-Week 2 and Part B: Week 4-Week 12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 17 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this 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.
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
- Being tested
- Part A: Baseline-Week 2, Part B: Week 4-Week 12
- Keywords
- Fitzpatrick Skin-Type, Melanin, Ultraviolet Light (UV)
- Medical subject headings
- Skin Diseases, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A: Baseline-Week 2Other
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 12Other
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Healthy volunteers without cutaneous disorders associated with pigmentary changes Receives: Other: Part A: Baseline-Week 2; Other: Part B: Week 4-Week 12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin
Measured: 12 weeks
Quantification of the scattering and absorption properties of the skin in which the beam of light will penetrate using DRS
Measured: 12 weeks
Measurement of pigmentation changes induced by the two light sources using diffuse reflectance spectrometer
Measured: 12 weeks
Measurement of pigmentation changes induced by the two light sources using Colorimetry
Measured: 12 weeks
Measurement of pigmentation changes induced by the two light sources using Cross-Polarized Digital Photography
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startSep 2015
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Soter, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663921
- Sponsor's protocol ID
- 14-02039
- Status last verified
- Jun 2019
- First submitted
- 21 Jan 2016
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02663921
- Acronym / sponsor ID
- 14-02039
- Conditions
- Skin Disease, Pigment Disorders
- Keywords
- Fitzpatrick Skin-Type, Melanin, Ultraviolet Light (UV)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: Part A: Baseline-Week 2, Other: Part B: Week 4-Week 12Healthy volunteers without cutaneous disorders associated with pigmentary changes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part A: Baseline-Week 2The 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. | Other | Healthy volunteers |
| Part B: Week 4-Week 12The 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 | Other | Healthy volunteers |
Primary outcome
Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin
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 diffuse reflectance spectrometer
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 Cross-Polarized Digital Photography
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
Related trials for Skin Disease
RecruitingObservational study
Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor
Axial Spondylarthritis (axSpA), Psoriatic Arthritis (PsA)
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Enrolling by invitation
Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
Androgenic Alopecia, Hair Loss/Baldness
Not yet recruiting
Decision Support for Chemoprevention
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Soter principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Part A: Baseline-Week 2 and Part B: Week 4-Week 12 in people with Skin Disease and Pigment Disorders, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffuse Reflectance Spectroscopy (DRS) to examine the optical properties of melanin and deoxyhemoglobin (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.