<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/NCT03033654</url>
  </required_header>
  <id_info>
    <org_study_id>H-1-2014-094</org_study_id>
    <nct_id>NCT03033654</nct_id>
  </id_info>
  <brief_title>Two Consecutive Sunscreen Applications Optimize Sun Protection</brief_title>
  <official_title>Two Consecutive Sunscreen Applications Optimize Sun Protection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to investigate how much two consecutive applications of sunscreen&#xD;
      before sun exposure can increase the quantities of sunscreen applied and decrease the skin&#xD;
      area left without sunscreen compared to a single application. Volunteers wearing swimwear&#xD;
      applied sunscreen in a laboratory environment twice and had pictures taken in black light&#xD;
      before and after. As sunscreens absorb black light the darkness of the skin increased with&#xD;
      increasing amounts of sunscreen applied. The investigators conducted a standard curve&#xD;
      establishing a link between picture darkness and applied sunscreen quantity. Participants&#xD;
      were asked to apply sunscreen the way they would normally do but two consecutive times. No&#xD;
      other advice was given. The level of protection was determined by picture analysis as&#xD;
      measurements of darkness of selected skin sites as well as the percentages of skin area left&#xD;
      without sunscreen in different body regions and in total.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sun protection</measure>
    <time_frame>The day of intervention. Sun protection will be assessed right after sunscreen application.</time_frame>
    <description>Sun protection will be determined as sunscreen quantities applied in mg/cm^2 and areas of covered skin in percentage.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Sun Protection</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two Consecutive Sunscreen Applications</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sunscreen, Actinica</intervention_name>
    <description>Two Consecutive Sunscreen Applications</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Caucasians between older than 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffering from a skin disease, were allergic to the content in sunscreen, were&#xD;
             pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Ida M. Heerfordt</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <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/NCT03033654
org study id: H-1-2014-094
nct id: NCT03033654
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim to investigate how much two consecutive applications of sunscreen
      before sun exposure can increase the quantities of sunscreen applied and decrease the skin
      area left without sunscreen compared to a single application. Volunteers wearing swimwear
      applied sunscreen in a laboratory environment twice and had pictures taken in black light
      before and after. As sunscreens absorb black light the darkness of the skin increased with
      increasing amounts of sunscreen applied. The investigators conducted a standard curve
      establishing a link between picture darkness and applied sunscreen quantity. Participants
      were asked to apply sunscreen the way they would normally do but two consecutive times. No
      other advice was given. The level of protection was determined by picture analysis as
      measurements of darkness of selected skin sites as well as the percentages of skin area left
      without sunscreen in different body regions and in total.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Sun protection
time frame: The day of intervention. Sun protection will be assessed right after sunscreen application.
description: Sun protection will be determined as sunscreen quantities applied in mg/cm^2 and areas of covered skin in percentage.
arm group label: Intervention
arm group type: Experimental
description: Two Consecutive Sunscreen Applications
intervention type: Other
intervention name: Sunscreen, Actinica
description: Two Consecutive Sunscreen Applications
arm group label: Intervention
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Ida M. Heerfordt
investigator title: MD
mesh term: Sunscreening Agents
sharing ipd: No