Optimizing Phototesting and Investigating Photobiology of Visible Light

NCT05964907 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 14869
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (16)

• Erythema assessment for all 14 participants.

  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

  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

  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

  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)

• Erythema assessment for all 14 participants

  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

  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

  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

  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.

  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

  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

  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

  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..

  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)

• Pigmentation assessment for all 14 participants

  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

  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

  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)

Secondary Outcomes (4)

• Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants

  Visit 1 (Day 0)

• Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants

  Visit 2 (Day 1)

• Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants

  Visit 3 (Day 7)

• RNA sequencing for 8 participants

  Visit 2 (Day 1)

Study Arms (1)

VL+UVA1

OTHER

Participants will be treated with VL + UVA1 light source

Device: Light Source B: Visible Light solar simulator (VL + UVA1); Device: Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)

Interventions

Light Source B: Visible Light solar simulator (VL + UVA1) DEVICE

Patients will be radiated with light source B (Visible light solar simulator)

VL+UVA1

Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1) DEVICE

Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight)

VL+UVA1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Study Officials

• Indermeet Kohli, PhD

  Henry Ford Health Dermatology Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: July 28, 2023
• Study Start: October 6, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)