<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/NCT03007589</url>
  </required_header>
  <id_info>
    <org_study_id>SPF-2014-001</org_study_id>
    <nct_id>NCT03007589</nct_id>
  </id_info>
  <brief_title>Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics</brief_title>
  <official_title>Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Protection Foundation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Protection Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess how human skin reacts and how sunscreens and sun&#xD;
      protection fabrics protect in natural sunlight compared to their labeled claims, indoor&#xD;
      testing methods (existing or modified) and instructions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the difference in the level of erythema and persistent pigment darkening sun&#xD;
      protection following a single period of natural sunlight exposure or laboratory solar&#xD;
      simulator exposure afforded by application of sunscreens, use of fabrics, and use of pass&#xD;
      through glass filters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Anticipated">January 2030</completion_date>
  <primary_completion_date type="Anticipated">January 2030</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Erythema</measure>
    <time_frame>16-24 hours post exposure to natural sunlight</time_frame>
    <description>• Erythema was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible erythema but spotty or without clear borders (&lt;1 MED); 2 = minimal erythema over the entire site with distinct borders (1 MED reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters.&#xD;
Determination made by blinded evaluator on-site or using chroma-meter and photographs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistent Pigment Darkening (PPD)</measure>
    <time_frame>16-24 hours post exposure to natural sunlight</time_frame>
    <description>Persistent Pigment Darkening was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible but spotty or without clear borders (&lt;1 MPPDD); 2 = minimal PPD over the entire site with distinct borders (1 MPPDD reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters&#xD;
Determination made by blinded evaluator on-site or using chroma-meter and photographs.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Sunburn</condition>
  <condition>Sun Damaged Skin</condition>
  <condition>Overexposure to Sun Rays</condition>
  <arm_group>
    <arm_group_label>Location</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Location and Intensity of Exposure to Sunlight otc sunscreens sun protection fabrics optical filters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Duration or SPF Test</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single exposure of interventions or multiple exposures of interventions (SPF or PPD-PF tests) otc sunscreens sun protection fabrics optical filters</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>otc sunscreens</intervention_name>
    <description>Sunscreens of various SPF levels and ingredients</description>
    <arm_group_label>Location</arm_group_label>
    <arm_group_label>Single Duration or SPF Test</arm_group_label>
    <other_name>30 SPF Broad Spectrum Sunscreen</other_name>
    <other_name>40 SPF Broad Spectrum Sunscreen</other_name>
    <other_name>45 SPF Broad Spectrum Sunscreen</other_name>
    <other_name>50 SPF Broad Spectrum Sunscreen</other_name>
    <other_name>60 SPF Broad Spectrum Sunscreen</other_name>
    <other_name>100 SPF Broad Spectrum Sunscreen</other_name>
    <other_name>110 SPF Broad Spectrum Sunscreen</other_name>
    <other_name>Sunscreen Standard P2 15 SPF</other_name>
    <other_name>Sunscreen Standard S2 12 UVA-PF</other_name>
    <other_name>Sunscreen Standard P1 4 SPF</other_name>
    <other_name>70 SPF Broad Spectrum Sunscreen</other_name>
    <other_name>85 SPF Broad Spectrum Sunscreen</other_name>
    <other_name>Reference Standard Sunscreens at various SPF levels</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sun protection fabrics</intervention_name>
    <description>fabrics</description>
    <arm_group_label>Location</arm_group_label>
    <arm_group_label>Single Duration or SPF Test</arm_group_label>
    <other_name>100+ SPF Broad Spectrum Fabric Solumbra</other_name>
    <other_name>30+ SPF Broad Spectrum Fabric Solumbra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optical Filters</intervention_name>
    <description>Optical band pass or long pass filters or surfaces/mirrors used in solar simulators</description>
    <arm_group_label>Location</arm_group_label>
    <arm_group_label>Single Duration or SPF Test</arm_group_label>
    <other_name>Pass Through Glass</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Fitzpatrick Type I, II, III, IV or V type skin.&#xD;
&#xD;
          2. Must be able to be exposed to natural sunlight for up to 4 hours in a prone position&#xD;
&#xD;
          3. Able to read, write, speak and understand the English language.&#xD;
&#xD;
          4. Has personally read, signed, and dated the Informed Consent Form (including HIPAA&#xD;
             disclosure) and Photograph Release&#xD;
&#xD;
          5. Generally in good health based on medical history reported by the subject&#xD;
&#xD;
          6. Healthy male or female subjects with no history or evidence of clinically relevant&#xD;
             medical disorder, as determined from a brief medical history interview.&#xD;
&#xD;
          7. Willing and able to follow the study instructions, including:&#xD;
&#xD;
               -  Remain outdoors exposed to the sun or in the laboratory for up to 4 hours on Day&#xD;
                  1 during the study with exposed skin on back protected by sunscreens and fabrics&#xD;
&#xD;
               -  Apply the specific sunscreens and fabrics to designated sites on the back and lie&#xD;
                  motionless.&#xD;
&#xD;
               -  No visual signs of recent sun exposure to the back.&#xD;
&#xD;
               -  No sunscreens or lotions recently used on the back.&#xD;
&#xD;
               -  Attend scheduled visits and intend to successfully complete the study&#xD;
&#xD;
               -  Stay out of the sun or stay indoors from sun exposure until after observation on&#xD;
                  Day 2.&#xD;
&#xD;
               -  Women are discouraged from using a bra that applies pressure to the skin site&#xD;
                  areas that may make it difficult to assess erythema or PPD on Day 2.&#xD;
&#xD;
               -  Refrain from using other sunscreen products or tanning bed use during the&#xD;
                  duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals with known allergies or sensitivities to sunscreens or any ingredient&#xD;
             contained in the test products or common topical skincare products, including&#xD;
             adhesives.&#xD;
&#xD;
          2. Perceptible erythema, PPD on the back as determined by the PI or designee.&#xD;
&#xD;
          3. Women known to be pregnant or nursing.&#xD;
&#xD;
          4. Individuals with any disease or condition of the skin (e.g., active [i.e. flaring]&#xD;
             eczema or psoriasis, skin cancer, atypical nevus, polymorphic light eruption (PMLE),&#xD;
             porphyria, systemic lupus erythematous (SLE), xeroderma pigmentosa (XP)) that could&#xD;
             interfere with the study or increase risk to the subject.&#xD;
&#xD;
          5. Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes,&#xD;
             hypertension, hyper/hypothyroidism, hypercholesterolemia&#xD;
&#xD;
          6. Subjects who are taking medication for chronic conditions that may make a subject more&#xD;
             sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)&#xD;
&#xD;
          7. Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which may&#xD;
             influence the outcome of the study&#xD;
&#xD;
          8. An individual who has any condition which in the PI's judgment makes the candidate an&#xD;
             inappropriate subject for study participation&#xD;
&#xD;
          9. Individuals with a condition or situation which, in the PI's opinion, may put the&#xD;
             subject at significant risk, may confound the study results, or may interfere&#xD;
             significantly with the subject's participation in the study&#xD;
&#xD;
         10. Individual viewed by the PI as not being able to complete the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaun Hughes, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Protection Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sun Protection Foundation</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Protection Foundation</name>
      <address>
        <city>Waimea</city>
        <state>Hawaii</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Protection Foundation</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Protection Foundation</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Protection Foundation</name>
      <address>
        <city>Arequipa</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
    <country>Peru</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>erythema</keyword>
  <keyword>persistent pigment darkening</keyword>
  <keyword>sunburn</keyword>
  <keyword>suntan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sunburn</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sunscreening Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03007589
org study id: SPF-2014-001
nct id: NCT03007589
lead sponsor: 
has dmc: No
The purpose of this study is to assess how human skin reacts and how sunscreens and sun
      protection fabrics protect in natural sunlight compared to their labeled claims, indoor
      testing methods (existing or modified) and instructions.
To evaluate the difference in the level of erythema and persistent pigment darkening sun
      protection following a single period of natural sunlight exposure or laboratory solar
      simulator exposure afforded by application of sunscreens, use of fabrics, and use of pass
      through glass filters.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Erythema
time frame: 16-24 hours post exposure to natural sunlight
description: • Erythema was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible erythema but spotty or without clear borders (<1 MED); 2 = minimal erythema over the entire site with distinct borders (1 MED reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters.
Determination made by blinded evaluator on-site or using chroma-meter and photographs.
measure: Persistent Pigment Darkening (PPD)
time frame: 16-24 hours post exposure to natural sunlight
description: Persistent Pigment Darkening was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible but spotty or without clear borders (<1 MPPDD); 2 = minimal PPD over the entire site with distinct borders (1 MPPDD reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters
Determination made by blinded evaluator on-site or using chroma-meter and photographs.
arm group label: Location
arm group type: Other
description: Location and Intensity of Exposure to Sunlight otc sunscreens sun protection fabrics optical filters
arm group label: Single Duration or SPF Test
arm group type: Other
description: Single exposure of interventions or multiple exposures of interventions (SPF or PPD-PF tests) otc sunscreens sun protection fabrics optical filters
intervention type: Drug
intervention name: otc sunscreens
description: Sunscreens of various SPF levels and ingredients
arm group label: Location
arm group label: Single Duration or SPF Test
other name: 30 SPF Broad Spectrum Sunscreen
other name: 40 SPF Broad Spectrum Sunscreen
other name: 45 SPF Broad Spectrum Sunscreen
other name: 50 SPF Broad Spectrum Sunscreen
other name: 60 SPF Broad Spectrum Sunscreen
other name: 100 SPF Broad Spectrum Sunscreen
other name: 110 SPF Broad Spectrum Sunscreen
other name: Sunscreen Standard P2 15 SPF
other name: Sunscreen Standard S2 12 UVA-PF
other name: Sunscreen Standard P1 4 SPF
other name: 70 SPF Broad Spectrum Sunscreen
other name: 85 SPF Broad Spectrum Sunscreen
other name: Reference Standard Sunscreens at various SPF levels
intervention type: Other
intervention name: sun protection fabrics
description: fabrics
arm group label: Location
arm group label: Single Duration or SPF Test
other name: 100+ SPF Broad Spectrum Fabric Solumbra
other name: 30+ SPF Broad Spectrum Fabric Solumbra
intervention type: Other
intervention name: Optical Filters
description: Optical band pass or long pass filters or surfaces/mirrors used in solar simulators
arm group label: Location
arm group label: Single Duration or SPF Test
other name: Pass Through Glass
criteria: 
gender: All
minimum age: 15 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shaun Hughes, MBA
role: Principal Investigator
affiliation: Sun Protection Foundation
facility: 
facility: 
facility: 
facility: 
facility: 
country: Chile
country: Peru
country: United States
responsible party type: Sponsor
mesh term: Sunburn
mesh term: Sunscreening Agents
sharing ipd: No