Optimizing Phototesting and Investigating Photobiology of Visible Light

April 30, 2026 updated by: Indermeet Kohli, Henry Ford Health System

Specific Aim 1: To determine the impact of spectral composition of the VL+UVA1 source on the associated biologic effects.

Specific Aim 2: To investigate differential responses of subjects with different skin phototypes to VL+UVA1, including immediate and delayed erythema and pigmentation, and photodamage.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The design of the study consists of a total of 4 visits within a two week period. The first visit consists of VL+UVA1 irradiation with different light source on the opposite site of patients' back. A combination of non-invasive measurements (e.g., photography, redness and color changes of the skin using colorimetry and diffuse reflectance spectrometry) will be conducted throughout the 4 visits. Biopsies will be taken at various time points.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy individuals age 18 and older
  • Fitzpatrick skin phototype (SPT) I-VI, 7 with SPT I-III and 7 with SPT IV-VI, with normal healthy skin
  • Able to understand the requirements of the study and its associated risks
  • Able to complete and sign a consent form
  • Willing and able to refrain from any medications or herbal supplements during the duration of the study, unless permitted by the investigator
  • Agrees to refrain from using any new topical skin care products, laundry detergents, or fragrances while participating in the study
  • Has not had excessive sun exposure for 7 days prior to enrollment in the study

Exclusion Criteria:

  • Recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post-inflammatory hyperpigmentation
  • History of relevant skin conditions such as atopic dermatitis, eczema, or sunburn on any part of the body
  • History of photodermatoses or photosensitivity disorders
  • History of melanoma or non-melanoma skin cancers
  • Use of tanning parlors or exposure of the irradiated sites to sun light during the duration of the study
  • Use of topical or systemic treatment that is likely to interfere with assessment, study results, or pose safety concerns
  • Subjects with a tendency to bleed excessively
  • Known allergies to anesthetics (lidocaine) or anaphylaxis treatment (epinephrine)
  • History of hypertrophic scarring or keloid formation
  • Use of any photosensitizing medication within the visible light range or additional medication at the discretion of the investigator [examples include - but not limited to - thiazide diuretics, regular use of NSAIDs, hydroxychloroquine, or voriconazole
  • A woman who is lactating, pregnant, or planning to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: VL+UVA1
Participants will be treated with VL + UVA1 light source
Device: Light Source B: Visible Light solar simulator (VL + UVA1)
Patients will be radiated with light source B (Visible light solar simulator)
Device: Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)
Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Erythema assessment for all 14 participants
Time Frame: Visit 1 (Day 0)

Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].

Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Visit 1 (Day 0)
Erythema assessment for all 14 participants
Time Frame: Visit 2 (Day 1)

Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].

Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Visit 2 (Day 1)
Erythema assessment for all 14 participants
Time Frame: Visit 3 (Day 7)

Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].

Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Visit 3 (Day 7)
Erythema assessment for all 14 participants
Time Frame: Visit 4 (Day 14)

Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].

Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Visit 4 (Day 14)
Pigmentation assessment for all 14 participants
Time Frame: Visit 2 (Day 1)

Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].

Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Visit 2 (Day 1)
Pigmentation assessment for all 14 participants
Time Frame: Visit 3 (Day 7)

Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].

Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Visit 3 (Day 7)
Pigmentation assessment for all 14 participants
Time Frame: Visit 4 (Day 14)

Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].

Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Visit 4 (Day 14)
Erythema assessment for all 14 participants.
Time Frame: Visit 1 (Day 0)

Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema

  1. Almost clear of erythema
  2. Mild, but noticeable erythema
  3. Moderate erythema (pink), no sharp borders
  4. Severe erythema (dark pink), sharp borders
  5. Very severe erythema (very dark pink to almost red)
Visit 1 (Day 0)
Erythema assessment for all participants
Time Frame: Visit 2 (Day 1)

Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema

  1. Almost clear of erythema
  2. Mild, but noticeable erythema
  3. Moderate erythema (pink), no sharp borders
  4. Severe erythema (dark pink), sharp borders
  5. Very severe erythema (very dark pink to almost red)
Visit 2 (Day 1)
Erythema assessment
Time Frame: Visit 3 (Day 7)

Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema

  1. Almost clear of erythema
  2. Mild, but noticeable erythema
  3. Moderate erythema (pink), no sharp borders
  4. Severe erythema (dark pink), sharp borders
  5. Very severe erythema (very dark pink to almost red)
Visit 3 (Day 7)
Erythema assessment for 14 participants
Time Frame: Visit 4 (Day 14)

Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema

  1. Almost clear of erythema
  2. Mild, but noticeable erythema
  3. Moderate erythema (pink), no sharp borders
  4. Severe erythema (dark pink), sharp borders
  5. Very severe erythema (very dark pink to almost red)
Visit 4 (Day 14)
Pigmentation assessment for all 14 participants.
Time Frame: Visit 1 (day 0)

Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation

  1. Almost clear of hyperpigmentation
  2. Mild, but noticeable hyperpigmentation
  3. Moderate hyperpigmentation (medium brown)
  4. Severe hyperpigmentation (dark brown)
  5. Very severe hyperpigmentation (very dark brown to almost black)
Visit 1 (day 0)
Pigmentation assessment for all 14
Time Frame: Visit 2 (Day 1)

Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation

  1. Almost clear of hyperpigmentation
  2. Mild, but noticeable hyperpigmentation
  3. Moderate hyperpigmentation (medium brown)
  4. Severe hyperpigmentation (dark brown)
  5. Very severe hyperpigmentation (very dark brown to almost black)
Visit 2 (Day 1)
Pigmentation assessment for 14 participants
Time Frame: Visit 3 (Day 7)

Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation

  1. Almost clear of hyperpigmentation
  2. Mild, but noticeable hyperpigmentation
  3. Moderate hyperpigmentation (medium brown)
  4. Severe hyperpigmentation (dark brown)
  5. Very severe hyperpigmentation (very dark brown to almost black)
Visit 3 (Day 7)
Pigmentation assessment for all 14
Time Frame: Visit 4 (Day 14)

Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation

  1. Almost clear of hyperpigmentation
  2. Mild, but noticeable hyperpigmentation
  3. Moderate hyperpigmentation (medium brown)
  4. Severe hyperpigmentation (dark brown)
  5. Very severe hyperpigmentation (very dark brown to almost black)
Visit 4 (Day 14)
Pigmentation assessment for all 14 participants..
Time Frame: Visit 1 (day 0)

Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].

Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Visit 1 (day 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Time Frame: Visit 1 (Day 0)
Histology assess parameter including pigmentation, inflammation and proliferation.
Visit 1 (Day 0)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Time Frame: Visit 2 (Day 1)
Histology assess parameter including pigmentation, inflammation and proliferation.
Visit 2 (Day 1)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Time Frame: Visit 3 (Day 7)
Histology assess parameter including pigmentation, inflammation and proliferation.
Visit 3 (Day 7)
RNA sequencing for 8 participants
Time Frame: Visit 2 (Day 1)
Molecular changes- sample collection for RNA sequencing
Visit 2 (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henry Ford Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Indermeet Kohli, PhD, Henry Ford Health Dermatology Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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