<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/NCT03253484</url>
  </required_header>
  <id_info>
    <org_study_id>H-17012492</org_study_id>
    <nct_id>NCT03253484</nct_id>
  </id_info>
  <brief_title>Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling</brief_title>
  <official_title>Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to explore the potential clinical effect of targeting&#xD;
      surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to&#xD;
      reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1)&#xD;
      inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding,&#xD;
      2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3)&#xD;
      remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, controlled, assessor - blinded, intra-individual trial&#xD;
      comparing laser exposed skin lesions to untreated control skin lesions in a split scar set-up&#xD;
      to investigate efficacy. The study will be performed on patients undergoing an excision at&#xD;
      Bispebjerg Dermatological Department. One randomly allocated part of each included wound will&#xD;
      receive three NAFL-treatments and the other part will serve as untreated control wound. Scars&#xD;
      will be evaluated clinically on-site by blinded evaluator immediately before third treatment&#xD;
      and 3 months after NAFL-treatments. The clinical data will be supplemented by blinded&#xD;
      photo-evaluation, patients' evaluation and non-invasive measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 18, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2018</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>
    <intervention_model_description>split scar study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>the outcome assessor will not know which side is the treated side of scar</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clincial evaluation on Patient observer scar assessement scale (POSAS)</measure>
    <time_frame>3 months followup</time_frame>
    <description>validated scar scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Photoevaluation on visual analogue scale</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>3 independent dermatologists will evaluate on VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflectance measurement</measure>
    <time_frame>3 months followup</time_frame>
    <description>measurement of erythema and pigment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evaluation on Vancouver Scar Scale</measure>
    <time_frame>3 months followup</time_frame>
    <description>validated scar scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clincial evaluation on Patient observer scar assessement scale (POSAS)</measure>
    <time_frame>1month follow-up</time_frame>
    <description>validated scar scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evaluation on Vancouver Scar Scale</measure>
    <time_frame>1month follow-up and</time_frame>
    <description>validated scar scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Scar Improvement by Laser</condition>
  <arm_group>
    <arm_group_label>NAFL-treated wounds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NAFL treated wounds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>untreated control wound</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>NAFL-treatment</intervention_name>
    <description>non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation</description>
    <arm_group_label>NAFL-treated wounds</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  o Subjects referred to excision of either benign, pre malignant or malignant&#xD;
             non-melanoma skin cancer (NMSC) lesions.&#xD;
&#xD;
               -  The length of postoperative wound should be estimated to minimum 2.5 cm and may&#xD;
                  be located on any region of the body&#xD;
&#xD;
               -  Minimum 18 years old&#xD;
&#xD;
               -  Presenting full medical record report at study initiation&#xD;
&#xD;
               -  Fitzpatrick skin type I-III&#xD;
&#xD;
               -  Non-smokers&#xD;
&#xD;
               -  Written informed consent obtained from subject&#xD;
&#xD;
               -  Understanding of investigation procedures and willingness to abide to all&#xD;
                  procedures during the course of the investigation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  o History of or presenting with a keloid scar&#xD;
&#xD;
               -  A subject with a systemic disease not yet stabilized&#xD;
&#xD;
               -  If the patient is pregnant&#xD;
&#xD;
               -  Visible recent sun exposure in test area&#xD;
&#xD;
               -  Significant history or current evidence of a medical, psychological or other&#xD;
                  disorder that, in the investigator's opinion, would preclude enrollment into the&#xD;
                  study&#xD;
&#xD;
               -  Current use of topical treatment and lack of willingness to refrain from future&#xD;
                  use of topical treatment, such as i.e. silicone products, that potentially can&#xD;
                  interfere with the test results&#xD;
&#xD;
               -  Unable to follow the outlined study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Katrine Elisabeth Karmisholt</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>scar NAFL laser</keyword>
  <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/NCT03253484
org study id: H-17012492
nct id: NCT03253484
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The primary objective of this study is to explore the potential clinical effect of targeting
      surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to
      reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1)
      inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding,
      2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3)
      remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.
This is a prospective, randomized, controlled, assessor - blinded, intra-individual trial
      comparing laser exposed skin lesions to untreated control skin lesions in a split scar set-up
      to investigate efficacy. The study will be performed on patients undergoing an excision at
      Bispebjerg Dermatological Department. One randomly allocated part of each included wound will
      receive three NAFL-treatments and the other part will serve as untreated control wound. Scars
      will be evaluated clinically on-site by blinded evaluator immediately before third treatment
      and 3 months after NAFL-treatments. The clinical data will be supplemented by blinded
      photo-evaluation, patients' evaluation and non-invasive measurements.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: split scar study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: the outcome assessor will not know which side is the treated side of scar
measure: Clincial evaluation on Patient observer scar assessement scale (POSAS)
time frame: 3 months followup
description: validated scar scale
measure: Photoevaluation on visual analogue scale
time frame: 3 months follow-up
description: 3 independent dermatologists will evaluate on VAS
measure: Reflectance measurement
time frame: 3 months followup
description: measurement of erythema and pigment
measure: Clinical evaluation on Vancouver Scar Scale
time frame: 3 months followup
description: validated scar scale
measure: Clincial evaluation on Patient observer scar assessement scale (POSAS)
time frame: 1month follow-up
description: validated scar scale
measure: Clinical evaluation on Vancouver Scar Scale
time frame: 1month follow-up and
description: validated scar scale
arm group label: NAFL-treated wounds
arm group type: Experimental
description: NAFL treated wounds
arm group label: Control
arm group type: No Intervention
description: untreated control wound
intervention type: Radiation
intervention name: NAFL-treatment
description: non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation
arm group label: NAFL-treated wounds
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Katrine Elisabeth Karmisholt
investigator title: MD
sharing ipd: No