Optimizing Phototesting and Investigating Photobiology of Visible Light

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: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: Light Source B: Visible Light solar simulator (VL + UVA1); Device: Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)

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: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fanar Razoky, Bachelors; Phone Number: 313-694-1923; Email: Frazoky1@hfhs.org
• Study Contact Backup: Name: Indermeet Kohli, PhD; Phone Number: 313-220-4576; Email: ikohli1@hfhs.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	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)
Erythema assessment for all 14 participants.	Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema; Almost clear of erythema; Mild, but noticeable erythema; Moderate erythema (pink), no sharp borders; Severe erythema (dark pink), sharp borders; 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; Almost clear of erythema; Mild, but noticeable erythema; Moderate erythema (pink), no sharp borders; Severe erythema (dark pink), sharp borders; 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; Almost clear of erythema; Mild, but noticeable erythema; Moderate erythema (pink), no sharp borders; Severe erythema (dark pink), sharp borders; 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; Almost clear of erythema; Mild, but noticeable erythema; Moderate erythema (pink), no sharp borders; Severe erythema (dark pink), sharp borders; Very severe erythema (very dark pink to almost red)	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; Almost clear of hyperpigmentation; Mild, but noticeable hyperpigmentation; Moderate hyperpigmentation (medium brown); Severe hyperpigmentation (dark brown); 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; Almost clear of hyperpigmentation; Mild, but noticeable hyperpigmentation; Moderate hyperpigmentation (medium brown); Severe hyperpigmentation (dark brown); 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; Almost clear of hyperpigmentation; Mild, but noticeable hyperpigmentation; Moderate hyperpigmentation (medium brown); Severe hyperpigmentation (dark brown); 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; Almost clear of hyperpigmentation; Mild, but noticeable hyperpigmentation; Moderate hyperpigmentation (medium brown); Severe hyperpigmentation (dark brown); 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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants	Histology assess parameter including pigmentation, inflammation and proliferation.	Visit 1 (Day 0)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants	Histology assess parameter including pigmentation, inflammation and proliferation.	Visit 2 (Day 1)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants	Histology assess parameter including pigmentation, inflammation and proliferation.	Visit 3 (Day 7)
RNA sequencing for 8 participants	Molecular changes- sample collection for RNA sequencing	Visit 2 (Day 1)

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID 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