Optimizing Phototesting and Investigating Photobiology of Visible Light

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Phototesting and Investigating Photobiology of Visible Light

Conditions
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Healthy

Intervention / Treatment
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* Device: Light Source B: Visible Light solar simulator (VL + UVA1)
* Device: Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VL+UVA1<br>Participants will be treated with VL + UVA1 light source | Device: Light Source B: Visible Light solar simulator (VL + UVA1)<br>* Patients will be radiated with light source B (Visible light solar simulator)<br>Device: Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)<br>* Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 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) | 
| 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 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) |