<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/NCT02251756</url>
  </required_header>
  <id_info>
    <org_study_id>RD.03.CIP.29114</org_study_id>
    <secondary_id>ID RCB: 2014-A00491-46</secondary_id>
    <nct_id>NCT02251756</nct_id>
  </id_info>
  <brief_title>Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.</brief_title>
  <official_title>Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study objective To assess the performance of different application regimens of Actinica® on&#xD;
      protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned&#xD;
      healthy subjects (phototype I to III).&#xD;
&#xD;
      Study centers A total of 20 subjects will be enrolled in 1 site in France.&#xD;
&#xD;
      Methodology This will be a monocentre, randomised, controlled, investigator-blind,&#xD;
      intra-individual comparative clinical investigation.&#xD;
&#xD;
      There will be a total of 6 visits for each subject. Each subject will participate for a&#xD;
      period of maximum 35 days.&#xD;
&#xD;
      Study population Healthy subjects, male or female, at least 18-60 years old, with phototype&#xD;
      I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion&#xD;
      criteria.&#xD;
&#xD;
      The clinical investigation will be conducted in 2 parts.&#xD;
&#xD;
      Part 1 - SPF determination:&#xD;
&#xD;
      To determine the SPF of Actinica® with application of two different amounts (0.8 and 2&#xD;
      mg/cm2).&#xD;
&#xD;
      Part 2 - Sun exposure:&#xD;
&#xD;
      To assess the performance of the different application regimens of Actinica® on protection&#xD;
      from UVR-induced erythema throughout 1 day of sun exposure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>erythema score</measure>
    <time_frame>Part 2 -Day 1</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin</condition>
  <arm_group>
    <arm_group_label>Actinica, 0.8 mg/cm2, 1application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Actinica, 0.8 mg/cm2, 1application over one day of sun exposure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Actinica, 0.8 mg/cm2, 2 applications</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Actinica, 0.8 mg/cm2, 2 applications over one day of sun exposure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Actinica, 2 mg/cm2, 1 application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Actinica, 2 mg/cm2, 1 application over one day of sun exposure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Actinica, 2 mg/cm2, 2 applications</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Actinica, 2 mg/cm2, 1 application over one day of sun exposure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Actinica, 0.8 mg/cm2, 1 application</intervention_name>
    <arm_group_label>Actinica, 0.8 mg/cm2, 1application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Actinica, 0.8 mg/cm2, 2 applications</intervention_name>
    <arm_group_label>Actinica, 0.8 mg/cm2, 2 applications</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Actinica, 2 mg/cm2, 1 application</intervention_name>
    <arm_group_label>Actinica, 2 mg/cm2, 1 application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Actinica, 2 mg/cm2, 2 applications</intervention_name>
    <arm_group_label>Actinica, 2 mg/cm2, 2 applications</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, 18-60 years of age,&#xD;
&#xD;
          2. Subject with Phototype I, II or III,&#xD;
&#xD;
          3. Subject with individual typology angle (ITA) 28-70°,&#xD;
&#xD;
          4. Subject with healthy skin / not tanned on the back,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Subject with obvious skin cancer forms within the test areas, 2. Subject with hairs on&#xD;
        the treated area that might interfere with clinical investigation assessments, 3. Subjects&#xD;
        who have performed sun bathing at least four months before enrolment, 10. History of sun&#xD;
        allergy / Mallorca acne, active photo induced or photo aggravated disease, or abnormal&#xD;
        response to the sun (e.g., photosensitive dermatoses, polymorphic light eruption, solar&#xD;
        urticaria, systemic lupus erythematosus, or dermatomyositis).&#xD;
&#xD;
        11. The subject has received, applied or taken the forbidden treatments within the&#xD;
        specified time frame prior to the Day 0 visit (list available on request)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erythema</mesh_term>
  </condition_browse>
  <!-- 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/NCT02251756
org study id: RD.03.CIP.29114
secondary id: ID RCB: 2014-A00491-46
nct id: NCT02251756
lead sponsor: 
has dmc: No
Study objective To assess the performance of different application regimens of Actinica® on
      protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned
      healthy subjects (phototype I to III).

      Study centers A total of 20 subjects will be enrolled in 1 site in France.

      Methodology This will be a monocentre, randomised, controlled, investigator-blind,
      intra-individual comparative clinical investigation.

      There will be a total of 6 visits for each subject. Each subject will participate for a
      period of maximum 35 days.

      Study population Healthy subjects, male or female, at least 18-60 years old, with phototype
      I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion
      criteria.

      The clinical investigation will be conducted in 2 parts.

      Part 1 - SPF determination:

      To determine the SPF of Actinica® with application of two different amounts (0.8 and 2
      mg/cm2).

      Part 2 - Sun exposure:

      To assess the performance of the different application regimens of Actinica® on protection
      from UVR-induced erythema throughout 1 day of sun exposure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: erythema score
time frame: Part 2 -Day 1
arm group label: Actinica, 0.8 mg/cm2, 1application
arm group type: Experimental
description: Actinica, 0.8 mg/cm2, 1application over one day of sun exposure
arm group label: Actinica, 0.8 mg/cm2, 2 applications
arm group type: Experimental
description: Actinica, 0.8 mg/cm2, 2 applications over one day of sun exposure
arm group label: Actinica, 2 mg/cm2, 1 application
arm group type: Experimental
description: Actinica, 2 mg/cm2, 1 application over one day of sun exposure
arm group label: Actinica, 2 mg/cm2, 2 applications
arm group type: Experimental
description: Actinica, 2 mg/cm2, 1 application over one day of sun exposure
intervention type: Device
intervention name: Actinica, 0.8 mg/cm2, 1 application
arm group label: Actinica, 0.8 mg/cm2, 1application
intervention type: Device
intervention name: Actinica, 0.8 mg/cm2, 2 applications
arm group label: Actinica, 0.8 mg/cm2, 2 applications
intervention type: Device
intervention name: Actinica, 2 mg/cm2, 1 application
arm group label: Actinica, 2 mg/cm2, 1 application
intervention type: Device
intervention name: Actinica, 2 mg/cm2, 2 applications
arm group label: Actinica, 2 mg/cm2, 2 applications
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Erythema