<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/NCT03036306</url>
  </required_header>
  <id_info>
    <org_study_id>SCX-001-1</org_study_id>
    <nct_id>NCT03036306</nct_id>
  </id_info>
  <brief_title>Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions</brief_title>
  <official_title>A Randomized, Placebo Controlled, Double-blind, Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ScarX Corp</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ScarX Corp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and local tolerability of two different&#xD;
      concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a&#xD;
      day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition, the&#xD;
      absorption and elimination of profiles of this topically applied product will be determined&#xD;
      through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo will be done&#xD;
      but are considered exploratory.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">October 2, 2017</completion_date>
  <primary_completion_date type="Actual">October 2, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of Adverse Events and Tolerability Assessments</measure>
    <time_frame>4 months</time_frame>
    <description>Adverse events, Tolerability assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scar Size</measure>
    <time_frame>4 months</time_frame>
    <description>Repeat measurement of scar size by ultrasound following wound closure to the end of study and digital camera following wounding to the end of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scar Quality</measure>
    <time_frame>4 months</time_frame>
    <description>Repeat measurement of erythema and pigmentation of scars by mexameter following wound closure to the end of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Wound Closure</measure>
    <time_frame>4 months</time_frame>
    <description>Repeat examination of wounds for closure defined as 100% epithelialization of the wound with no exudate observed assessed form time of wounding to wound closure on both hips</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serial serum samples to determine AUC (0-6h, 0-8h)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum observed plasma concentration (Tmax)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serial serum samples to determine Tmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serial serum samples to determine Cmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene expression analysis</measure>
    <time_frame>Done on the day of the last dose of treatment (20 days following wounding)</time_frame>
    <description>RT-qPCR on scar biopsy samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological analysis</measure>
    <time_frame>Done on the day of the last dose of treatment (20 days following wounding)</time_frame>
    <description>Immunohistochemistry on scar biopsy samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collagen orientation analysis</measure>
    <time_frame>Done on the day of the last dose of treatment (20 days following wounding)</time_frame>
    <description>Collagen orientation index on scar biopsy samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Satisfaction</measure>
    <time_frame>4 months</time_frame>
    <description>Repeat measurement of both subject and investigator satisfaction with scar appearance by Subject and Observer Scar Assessment Scale (POSAS) following wound closure to the end of study</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Scarring</condition>
  <arm_group>
    <arm_group_label>1.0 % SCX-001 cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to this arm will have one lateral hip wound treated with 1.0% SCX-001 cream and one wound treated with placebo. Intra-subject hip wound treatment is randomly allocated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3.0% SCX-001 cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to this arm will have one lateral hip wound treated with 3.0% SCX-001 cream and one wound treated with placebo. Intra-subject hip wound treatment is randomly allocated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo cream</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects randomized to this arm will have both lateral hip wounds treated with Placebo cream. Intra-subject hip wound treatment is randomly allocated</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SCX-001</intervention_name>
    <description>Nefopam cream formulation</description>
    <arm_group_label>1.0 % SCX-001 cream</arm_group_label>
    <arm_group_label>3.0% SCX-001 cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Cream formulation without Nefopam</description>
    <arm_group_label>Placebo cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female volunteers aged ≥18 - ≤65 years who have voluntarily signed and dated&#xD;
             an Informed Consent Form (ICF).&#xD;
&#xD;
          2. Subjects with, in the opinion of the Investigator, clinically acceptable results at&#xD;
             screening for the laboratory tests specified in the trial protocol.&#xD;
&#xD;
          3. Women of child bearing potential must provide a negative pregnancy serum/urine test at&#xD;
             time of screening and have to be compliant with an effective form of birth control&#xD;
             throughout the entire study.* Non-child bearing potential means subjects have had a&#xD;
             history of tubal ligation or a hysterectomy or are post-menopausal with no menses for&#xD;
             at least 1 year prior to enrolment in the study.&#xD;
&#xD;
          4. Subjects, who are, in the opinion of the Investigator, able to understand the study,&#xD;
             co- operate with the study procedures and are willing to return to the clinic for all&#xD;
             of the required follow-up visits.&#xD;
&#xD;
          5. Subjects must be able to cooperate with requirements of the study (e.g. able to speak,&#xD;
             read and write English, expect to be available for adverse event monitoring for the&#xD;
             duration of the study).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have scarring from previous interventions or evidence of thermal,&#xD;
             electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the&#xD;
             treatment site.&#xD;
&#xD;
          2. Subjects with a history or family history of keloid formation.&#xD;
&#xD;
          3. Subjects with a concurrent illness or condition that may have interfered with wound&#xD;
             healing like neoplastic, immune-mediated, or primary infectious disease (e.g.&#xD;
             carcinoma, vasculitis, connective tissue disease, immune system disorders, rheumatoid&#xD;
             arthritis, chronic renal impairment, significant hepatic impairment, inadequately or&#xD;
             uncontrolled congestive heart failure or diabetes mellitus) or any clinically&#xD;
             significant medical condition or history of any condition which may impair wound&#xD;
             healing.&#xD;
&#xD;
          4. Subjects with a skin disorder that is chronic or currently active and which the&#xD;
             Investigator considers will adversely affect the healing of acute wounds or will&#xD;
             involve the areas to be examined in this trial (including psoriasis, dermatitis,&#xD;
             eczema)&#xD;
&#xD;
          5. Subjects with a body mass index &lt;15 or &gt;35 kg/m2.&#xD;
&#xD;
          6. A history of radiotherapy to the study scar area.&#xD;
&#xD;
          7. Subjects who have used nicotine-containing products (including vaping) within one&#xD;
             month prior to the screening visit.&#xD;
&#xD;
          8. Subjects who are positive for HIV, hepatitis B or C.&#xD;
&#xD;
          9. Subjects who have known sensitivities to SCX-001 Cream, structurally related compounds&#xD;
             or any of the constituents of SCX-001 Cream.&#xD;
&#xD;
         10. Subjects who have known sensitivities to EMLA cream, chlorhexidine or adhesive&#xD;
             dressings&#xD;
&#xD;
         11. Subjects with a history of any malignancy in the five years prior to the screening&#xD;
             visit.&#xD;
&#xD;
         12. Subjects with a life expectancy of &lt;9 months, terminal conditions or factors making&#xD;
             follow-up difficult (e.g. no fixed address, telephone etc.).&#xD;
&#xD;
         13. Subjects with planned major surgical intervention during the course of the study.&#xD;
&#xD;
         14. Subjects who have received corticosteroids, immunosuppressive agents, anticoagulants,&#xD;
             radiation therapy or chemotherapy at a dose that might have interfered with wound&#xD;
             healing within the last 90 days prior to study enrolment.&#xD;
&#xD;
         15. Subjects who have received NSAIDS or ASA in the past week.&#xD;
&#xD;
         16. Subjects with a creatinine clearance of 80 ml/min or less.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>scar</keyword>
  <keyword>nefopam</keyword>
  <keyword>cicatrix</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
  </condition_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/NCT03036306
org study id: SCX-001-1
nct id: NCT03036306
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and local tolerability of two different
      concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a
      day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition, the
      absorption and elimination of profiles of this topically applied product will be determined
      through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo will be done
      but are considered exploratory.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Occurrence of Adverse Events and Tolerability Assessments
time frame: 4 months
description: Adverse events, Tolerability assessments
measure: Scar Size
time frame: 4 months
description: Repeat measurement of scar size by ultrasound following wound closure to the end of study and digital camera following wounding to the end of the study
measure: Scar Quality
time frame: 4 months
description: Repeat measurement of erythema and pigmentation of scars by mexameter following wound closure to the end of study
measure: Time to Wound Closure
time frame: 4 months
description: Repeat examination of wounds for closure defined as 100% epithelialization of the wound with no exudate observed assessed form time of wounding to wound closure on both hips
measure: Area under the plasma concentration-time curve (AUC)
time frame: 4 weeks
description: Serial serum samples to determine AUC (0-6h, 0-8h)
measure: Time to reach maximum observed plasma concentration (Tmax)
time frame: 4 weeks
description: Serial serum samples to determine Tmax
measure: Maximum observed plasma concentration (Cmax)
time frame: 4 weeks
description: Serial serum samples to determine Cmax
measure: Gene expression analysis
time frame: Done on the day of the last dose of treatment (20 days following wounding)
description: RT-qPCR on scar biopsy samples
measure: Histological analysis
time frame: Done on the day of the last dose of treatment (20 days following wounding)
description: Immunohistochemistry on scar biopsy samples
measure: Collagen orientation analysis
time frame: Done on the day of the last dose of treatment (20 days following wounding)
description: Collagen orientation index on scar biopsy samples
measure: Overall Satisfaction
time frame: 4 months
description: Repeat measurement of both subject and investigator satisfaction with scar appearance by Subject and Observer Scar Assessment Scale (POSAS) following wound closure to the end of study
arm group label: 1.0 % SCX-001 cream
arm group type: Experimental
description: Subjects randomized to this arm will have one lateral hip wound treated with 1.0% SCX-001 cream and one wound treated with placebo. Intra-subject hip wound treatment is randomly allocated
arm group label: 3.0% SCX-001 cream
arm group type: Experimental
description: Subjects randomized to this arm will have one lateral hip wound treated with 3.0% SCX-001 cream and one wound treated with placebo. Intra-subject hip wound treatment is randomly allocated
arm group label: Placebo cream
arm group type: Placebo Comparator
description: Subjects randomized to this arm will have both lateral hip wounds treated with Placebo cream. Intra-subject hip wound treatment is randomly allocated
intervention type: Drug
intervention name: SCX-001
description: Nefopam cream formulation
arm group label: 1.0 % SCX-001 cream
arm group label: 3.0% SCX-001 cream
intervention type: Other
intervention name: Placebo
description: Cream formulation without Nefopam
arm group label: Placebo cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Cicatrix
sharing ipd: No