xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05964907</url>
    </required_header>
    <id_info>
      <org_study_id>14869</org_study_id>
      <nct_id>NCT05964907</nct_id>
    </id_info>
    <brief_title>Optimizing Phototesting and Investigating Photobiology of Visible Light</brief_title>
    <official_title>Optimizing Phototesting and Investigating Photobiology of Visible Light</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Henry Ford Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Henry Ford Health System</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Specific Aim 1: To determine the impact of spectral composition of the VL+UVA1 source on the&#xD;
        associated biologic effects.&#xD;
  &#xD;
        Specific Aim 2: To investigate differential responses of subjects with different skin&#xD;
        phototypes to VL+UVA1, including immediate and delayed erythema and pigmentation, and&#xD;
        photodamage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The design of the study consists of a total of 4 visits within a two week period. The first&#xD;
        visit consists of VL+UVA1 irradiation with different light source on the opposite site of&#xD;
        patients' back. A combination of non-invasive measurements (e.g., photography, redness and&#xD;
        color changes of the skin using colorimetry and diffuse reflectance spectrometry) will be&#xD;
        conducted throughout the 4 visits. Biopsies will be taken at various time points.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 6, 2021</start_date>
    <completion_date type="Anticipated">July 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Erythema assessment for all 14 participants</measure>
      <time_frame>Visit 1 (Day 0)</time_frame>
      <description>Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema&#xD;
  Almost clear of erythema&#xD;
  Mild, but noticeable erythema&#xD;
  Moderate erythema (pink), no sharp borders&#xD;
  Severe erythema (dark pink), sharp borders&#xD;
  Very severe erythema (very dark pink to almost red)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema assessment for all 14 participants</measure>
      <time_frame>Visit 2 (Day 1)</time_frame>
      <description>Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema&#xD;
  Almost clear of erythema&#xD;
  Mild, but noticeable erythema&#xD;
  Moderate erythema (pink), no sharp borders&#xD;
  Severe erythema (dark pink), sharp borders&#xD;
  Very severe erythema (very dark pink to almost red)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema assessment for all 14 participants</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema&#xD;
  Almost clear of erythema&#xD;
  Mild, but noticeable erythema&#xD;
  Moderate erythema (pink), no sharp borders&#xD;
  Severe erythema (dark pink), sharp borders&#xD;
  Very severe erythema (very dark pink to almost red)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema assessment for all 14 participants</measure>
      <time_frame>Visit 4 (Day 14)</time_frame>
      <description>Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema&#xD;
  Almost clear of erythema&#xD;
  Mild, but noticeable erythema&#xD;
  Moderate erythema (pink), no sharp borders&#xD;
  Severe erythema (dark pink), sharp borders&#xD;
  Very severe erythema (very dark pink to almost red)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema assessment for all 14 participants</measure>
      <time_frame>Visit 1 (Day 0)</time_frame>
      <description>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)].&#xD;
  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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema assessment for all 14 participants</measure>
      <time_frame>Visit 2 (Day 1)</time_frame>
      <description>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)].&#xD;
  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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema assessment for all 14 participants</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>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)].&#xD;
  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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema assessment for all 14 participants</measure>
      <time_frame>Visit 4 (Day 14)</time_frame>
      <description>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)].&#xD;
  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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pigmentation assessment for all 14 participants</measure>
      <time_frame>Visit 1 (day 0)</time_frame>
      <description>Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation&#xD;
  Almost clear of hyperpigmentation&#xD;
  Mild, but noticeable hyperpigmentation&#xD;
  Moderate hyperpigmentation (medium brown)&#xD;
  Severe hyperpigmentation (dark brown)&#xD;
  Very severe hyperpigmentation (very dark brown to almost black)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pigmentation assessment for all 14 participants</measure>
      <time_frame>Visit 2 (Day 1)</time_frame>
      <description>Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation&#xD;
  Almost clear of hyperpigmentation&#xD;
  Mild, but noticeable hyperpigmentation&#xD;
  Moderate hyperpigmentation (medium brown)&#xD;
  Severe hyperpigmentation (dark brown)&#xD;
  Very severe hyperpigmentation (very dark brown to almost black)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pigmentation assessment for all 14 participants</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation&#xD;
  Almost clear of hyperpigmentation&#xD;
  Mild, but noticeable hyperpigmentation&#xD;
  Moderate hyperpigmentation (medium brown)&#xD;
  Severe hyperpigmentation (dark brown)&#xD;
  Very severe hyperpigmentation (very dark brown to almost black)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pigmentation assessment for all 14 participants</measure>
      <time_frame>Visit 4 (Day 14)</time_frame>
      <description>Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation&#xD;
  Almost clear of hyperpigmentation&#xD;
  Mild, but noticeable hyperpigmentation&#xD;
  Moderate hyperpigmentation (medium brown)&#xD;
  Severe hyperpigmentation (dark brown)&#xD;
  Very severe hyperpigmentation (very dark brown to almost black)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pigmentation assessment for all 14 participants</measure>
      <time_frame>Visit 1 (day 0)</time_frame>
      <description>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)].&#xD;
  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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pigmentation assessment for all 14 participants</measure>
      <time_frame>Visit 2 (Day 1)</time_frame>
      <description>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)].&#xD;
  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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pigmentation assessment for all 14 participants</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>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)].&#xD;
  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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pigmentation assessment for all 14 participants</measure>
      <time_frame>Visit 4 (Day 14)</time_frame>
      <description>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)].&#xD;
  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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants</measure>
      <time_frame>Visit 1 (Day 0)</time_frame>
      <description>Histology assess parameter including pigmentation, inflammation and proliferation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants</measure>
      <time_frame>Visit 2 (Day 1)</time_frame>
      <description>Histology assess parameter including pigmentation, inflammation and proliferation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Histology assess parameter including pigmentation, inflammation and proliferation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RNA sequencing for 8 participants</measure>
      <time_frame>Visit 2 (Day 1)</time_frame>
      <description>Molecular changes- sample collection for RNA sequencing</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>VL+UVA1</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will be treated with VL + UVA1 light source</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Light Source B: Visible Light solar simulator (VL + UVA1)</intervention_name>
      <description>Patients will be radiated with light source B (Visible light solar simulator)</description>
      <arm_group_label>VL+UVA1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)</intervention_name>
      <description>Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight)</description>
      <arm_group_label>VL+UVA1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy individuals age 18 and older&#xD;
  &#xD;
            -  Fitzpatrick skin phototype (SPT) I-VI, 7 with SPT I-III and 7 with SPT IV-VI, with&#xD;
               normal healthy skin&#xD;
  &#xD;
            -  Able to understand the requirements of the study and its associated risks&#xD;
  &#xD;
            -  Able to complete and sign a consent form&#xD;
  &#xD;
            -  Willing and able to refrain from any medications or herbal supplements during the&#xD;
               duration of the study, unless permitted by the investigator&#xD;
  &#xD;
            -  Agrees to refrain from using any new topical skin care products, laundry detergents,&#xD;
               or fragrances while participating in the study&#xD;
  &#xD;
            -  Has not had excessive sun exposure for 7 days prior to enrollment in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Recent history of vitiligo, melasma, and other disorders of pigmentation with the&#xD;
               exception of post-inflammatory hyperpigmentation&#xD;
  &#xD;
            -  History of relevant skin conditions such as atopic dermatitis, eczema, or sunburn on&#xD;
               any part of the body&#xD;
  &#xD;
            -  History of photodermatoses or photosensitivity disorders&#xD;
  &#xD;
            -  History of melanoma or non-melanoma skin cancers&#xD;
  &#xD;
            -  Use of tanning parlors or exposure of the irradiated sites to sun light during the&#xD;
               duration of the study&#xD;
  &#xD;
            -  Use of topical or systemic treatment that is likely to interfere with assessment,&#xD;
               study results, or pose safety concerns&#xD;
  &#xD;
            -  Subjects with a tendency to bleed excessively&#xD;
  &#xD;
            -  Known allergies to anesthetics (lidocaine) or anaphylaxis treatment (epinephrine)&#xD;
  &#xD;
            -  History of hypertrophic scarring or keloid formation&#xD;
  &#xD;
            -  Use of any photosensitizing medication within the visible light range or additional&#xD;
               medication at the discretion of the investigator [examples include - but not limited&#xD;
               to - thiazide diuretics, regular use of NSAIDs, hydroxychloroquine, or voriconazole&#xD;
  &#xD;
            -  A woman who is lactating, pregnant, or planning to become pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Fanar Razoky, Bachelors</last_name>
      <phone>313-694-1923</phone>
      <email>frazoky1@hfhs.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Indermeet Kohli, PhD</last_name>
      <phone>313-220-4576</phone>
      <email>ikohli1@hfhs.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Henry Ford Medical Center</name>
        <address>
          <city>Detroit</city>
          <state>Michigan</state>
          <zip>48202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fanar Razoky, Bachelors</last_name>
        <phone>313-694-1923</phone>
        <email>Frazoky1@hfhs.org</email>
      </contact>
      <investigator>
        <last_name>Kohli Indermeet, Phd</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
      <investigator_full_name>Indermeet Kohli</investigator_full_name>
      <investigator_title>Associate Scientist</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05964907
  org study id: 14869
  nct id: NCT05964907
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Erythema assessment for all 14 participants
  time frame: Visit 1 (Day 0)
  description: 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)
  measure: Erythema assessment for all 14 participants
  time frame: Visit 2 (Day 1)
  description: 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)
  measure: Erythema assessment for all 14 participants
  time frame: Visit 3 (Day 7)
  description: 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)
  measure: Erythema assessment for all 14 participants
  time frame: Visit 4 (Day 14)
  description: 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)
  measure: Erythema assessment for all 14 participants
  time frame: Visit 1 (Day 0)
  description: 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
  measure: Erythema assessment for all 14 participants
  time frame: Visit 2 (Day 1)
  description: 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
  measure: Erythema assessment for all 14 participants
  time frame: Visit 3 (Day 7)
  description: 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
  measure: Erythema assessment for all 14 participants
  time frame: Visit 4 (Day 14)
  description: 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
  measure: Pigmentation assessment for all 14 participants
  time frame: Visit 1 (day 0)
  description: 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)
  measure: Pigmentation assessment for all 14 participants
  time frame: Visit 2 (Day 1)
  description: 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)
  measure: Pigmentation assessment for all 14 participants
  time frame: Visit 3 (Day 7)
  description: 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)
  measure: Pigmentation assessment for all 14 participants
  time frame: Visit 4 (Day 14)
  description: 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)
  measure: Pigmentation assessment for all 14 participants
  time frame: Visit 1 (day 0)
  description: 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
  measure: Pigmentation assessment for all 14 participants
  time frame: Visit 2 (Day 1)
  description: 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
  measure: Pigmentation assessment for all 14 participants
  time frame: Visit 3 (Day 7)
  description: 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
  measure: Pigmentation assessment for all 14 participants
  time frame: Visit 4 (Day 14)
  description: 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
  measure: Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
  time frame: Visit 1 (Day 0)
  description: Histology assess parameter including pigmentation, inflammation and proliferation.
  measure: Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
  time frame: Visit 2 (Day 1)
  description: Histology assess parameter including pigmentation, inflammation and proliferation.
  measure: Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
  time frame: Visit 3 (Day 7)
  description: Histology assess parameter including pigmentation, inflammation and proliferation.
  measure: RNA sequencing for 8 participants
  time frame: Visit 2 (Day 1)
  description: Molecular changes- sample collection for RNA sequencing
  arm group label: VL+UVA1
  arm group type: Other
  description: Participants will be treated with VL + UVA1 light source
  intervention type: Device
  intervention name: Light Source B: Visible Light solar simulator (VL + UVA1)
  description: Patients will be radiated with light source B (Visible light solar simulator)
  arm group label: VL+UVA1
  intervention type: Device
  intervention name: Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)
  description: Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight)
  arm group label: VL+UVA1
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fanar Razoky, Bachelors
  phone: 313-694-1923
  email: frazoky1@hfhs.org
  last name: Indermeet Kohli, PhD
  phone: 313-220-4576
  email: ikohli1@hfhs.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Henry Ford Health System
  investigator full name: Indermeet Kohli
  investigator title: Associate Scientist
  sharing ipd: No