<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/NCT02985437</url>
  </required_header>
  <id_info>
    <org_study_id>SMWH01</org_study_id>
    <secondary_id>2015-000890-11</secondary_id>
    <secondary_id>DRKS00011353</secondary_id>
    <nct_id>NCT02985437</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin</brief_title>
  <acronym>SATOSU</acronym>
  <official_title>Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin and Superficial Subepidermal Lesions in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Dr. Ursula Mirastschijski</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bremen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in&#xD;
      preterm infants. Here the drug is administered via airways.&#xD;
&#xD;
      The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is&#xD;
      not yet approved for the treatment of wound healing disorders. In the planned clinical trial&#xD;
      Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No&#xD;
      substance related side effects were observed during the application via airways in neonates.&#xD;
&#xD;
      The innovative idea to use lung surfactant for skin wound healing derived from two&#xD;
      observations. First, when the skin is injured, the barrier protecting the moist body surface&#xD;
      from the dry environment is discontinued and in part lost.&#xD;
&#xD;
      Lung surfactant has several characteristics that might be beneficial for treatment of chronic&#xD;
      cutaneous wounds.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2016</start_date>
  <completion_date type="Actual">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 30, 2017</primary_completion_date>
  <phase>Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits</measure>
    <time_frame>days 2,4,6,8,10,12,14 post baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface</measure>
    <time_frame>up to 14 days and one time follow up after 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain measured by mean Visual Analogue Scale over all visits</measure>
    <time_frame>days 2,4,6,8,10,12,14 post baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure</measure>
    <time_frame>day 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure</measure>
    <time_frame>day 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure</measure>
    <time_frame>day 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure</measure>
    <time_frame>day 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure</measure>
    <time_frame>day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure</measure>
    <time_frame>day 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure</measure>
    <time_frame>day 14</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>up to 14 days and one time follow up after 30 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Abnormal Laboratory Values</measure>
    <time_frame>Baseline and day 14</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Skin and Connective Tissue Diseases</condition>
  <arm_group>
    <arm_group_label>Surfactant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Surfactants</intervention_name>
    <arm_group_label>Surfactant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Solution</intervention_name>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Two healthy forearms,&#xD;
&#xD;
          -  No known chronical skin diseases,&#xD;
&#xD;
          -  Dermatoses or allergies,&#xD;
&#xD;
          -  Signed form of consent,&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or nursing period,&#xD;
&#xD;
          -  Diabetes (Type I or II),&#xD;
&#xD;
          -  Systemic or infectious diseases,&#xD;
&#xD;
          -  Skin disease,&#xD;
&#xD;
          -  Known allergies against bovine products or wound dressings,&#xD;
&#xD;
          -  Mental diseases, missing ability to consent,&#xD;
&#xD;
          -  Addictive disorders (e.g. alcohol, drugs),&#xD;
&#xD;
          -  Peripheral circulatory disorder, Morbus Raynaud,&#xD;
&#xD;
          -  Current (or &lt; 4 weeks ago) participation in clinical trials&#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>
  <overall_official>
    <last_name>Ursula Mirastschijski, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bremen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Bremen</name>
      <address>
        <city>Bremen</city>
        <zip>28359</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Bremen</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Dr. Ursula Mirastschijski</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>wound healing</keyword>
  <keyword>Bovine Lung Surfactant</keyword>
  <keyword>SATOSU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Connective Tissue Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Surfactants</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/NCT02985437
org study id: SMWH01
secondary id: 2015-000890-11
secondary id: DRKS00011353
nct id: NCT02985437
lead sponsor: 
collaborator: 
has dmc: No
Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in
      preterm infants. Here the drug is administered via airways.

      The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is
      not yet approved for the treatment of wound healing disorders. In the planned clinical trial
      Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No
      substance related side effects were observed during the application via airways in neonates.

      The innovative idea to use lung surfactant for skin wound healing derived from two
      observations. First, when the skin is injured, the barrier protecting the moist body surface
      from the dry environment is discontinued and in part lost.

      Lung surfactant has several characteristics that might be beneficial for treatment of chronic
      cutaneous wounds.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits
time frame: days 2,4,6,8,10,12,14 post baseline
measure: Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface
time frame: up to 14 days and one time follow up after 30 days
measure: Pain measured by mean Visual Analogue Scale over all visits
time frame: days 2,4,6,8,10,12,14 post baseline
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
time frame: day 2
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
time frame: day 4
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
time frame: day 6
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
time frame: day 8
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
time frame: day 10
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
time frame: day 12
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
time frame: day 14
measure: Adverse Events
time frame: up to 14 days and one time follow up after 30 days
measure: Number of Participants With Abnormal Laboratory Values
time frame: Baseline and day 14
arm group label: Surfactant
arm group type: Experimental
description: Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times
arm group label: Saline
arm group type: Active Comparator
description: 0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times
intervention type: Drug
intervention name: Surfactants
arm group label: Surfactant
intervention type: Drug
intervention name: Saline Solution
arm group label: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ursula Mirastschijski, Prof. Dr.
role: Principal Investigator
affiliation: University of Bremen
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University of Bremen
investigator full name: Prof. Dr. Dr. Ursula Mirastschijski
investigator title: Principal Investigator
mesh term: Connective Tissue Diseases
mesh term: Pulmonary Surfactants
sharing ipd: No