Optimizing Phototesting and Investigating Photobiology of Visible Light

Not Applicable

Active, not recruiting

• Conditions: Healthy

• Registration Number: NCT05964907
• Lead Sponsor: Henry Ford Health System

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.

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 Timeline

• Study Start: 2021-10-06
• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-07-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pigmentation assessment for all 14 participants.	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)
Erythema assessment for all 14 participants.	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)
Erythema assessment for all participants	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)
Erythema assessment	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)
Pigmentation assessment for all 14	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)
Erythema assessment for all 14 participants	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
Erythema assessment for 14 participants	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)
Pigmentation assessment for all 14 participants..	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
Pigmentation assessment for all 14 participants	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
Pigmentation assessment for 14 participants	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Henry Ford Medical Center; 🇺🇸 Detroit, Michigan, United States