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.
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
Patients will be radiated with light source B (Visible light solar simulator)
Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight)
Henry Ford Medical Center
Detroit, Michigan, United States
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Visit 4 (Day 14)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Histology assess parameter including pigmentation, inflammation and proliferation.
Time frame: Visit 1 (Day 0)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Histology assess parameter including pigmentation, inflammation and proliferation.
Time frame: Visit 2 (Day 1)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Histology assess parameter including pigmentation, inflammation and proliferation.
Time frame: Visit 3 (Day 7)
RNA sequencing for 8 participants
Molecular changes- sample collection for RNA sequencing
Time frame: Visit 2 (Day 1)