xml: <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/NCT06033352</url>
    </required_header>
    <id_info>
      <org_study_id>2023-D0015</org_study_id>
      <nct_id>NCT06033352</nct_id>
    </id_info>
    <brief_title>Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea</brief_title>
    <acronym>KIR</acronym>
    <official_title>Comparison of the Efficacy of Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser Combined With Ivermectin 1% Cream for Facial Rosacea: a Randomized Split-face Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Insel Gruppe AG, University Hospital Bern</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Insel Gruppe AG, University Hospital Bern</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>
        Rosacea is a frequent chronic inflammatory disease affecting mainly the face but also eyes&#xD;
        and scalp. Rosacea is classified into 3 types: erythemato-teleangiectatica, papulopustulosa&#xD;
        and phymatosa. Treatments depend on the type and include topical and systemic antibiotics,&#xD;
        azelaic acid, topical ivermectin, topical brimonidine, systemic isotretinoin as well as&#xD;
        intense pulsed light (IPL) and laser therapies.&#xD;
  &#xD;
        For treatment of telangiectasia and redness, laser and IPL therapies are the first choice.&#xD;
        Vascular lasers, such as pulsed dye lasers (PDL) and potassium-titanyl phosphate (KTP) lasers&#xD;
        as well as IPL, have demonstrated good efficacy in reduction of erythema and telangiectasias&#xD;
        in patients with rosacea. However, these treatments are expensive and mostly not covered by&#xD;
        the health insurance. Therefore, for patients it is important to receive the maximal effect&#xD;
        and improvement after each single laser session.&#xD;
  &#xD;
        Ivermectin is a semi-synthetic derivative of avermectin and has an anti-inflammatory effect&#xD;
        as well as an antiparasitic effect on demodex mite. The latter is playing an important&#xD;
        pathogenetic role in rosacea.&#xD;
  &#xD;
        This randomized controlled study aims to compare the effect of KTP laser in combination with&#xD;
        ivermectin 1% cream vs KTP laser alone in patients with facial rosacea.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</primary_completion_date>
    <phase>Phase 2</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>1:1 within-patient (split-face) random allocation</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Efficacy of laser and cream vs laser alone in reducing erythema as assessed by NEI</measure>
      <time_frame>16 weeks</time_frame>
      <description>Any relative decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Normalized Erythema Index (NEI), ranging from 0 to 80, with higher values indicating a worst erythema.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Efficacy of laser and cream vs laser alone in reducing erythema as assessed by SRI</measure>
      <time_frame>16 weeks</time_frame>
      <description>Any relative decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Skin Redness Index (SRI), ranging from 1 to 4, with higher score indicating a worst erythema.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of laser and cream vs laser alone in reducing erythema as assessed by CEA</measure>
      <time_frame>4, 8, 12, 16 weeks</time_frame>
      <description>Any decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Clinical Erythema Assessment (CEA), ranging from 0 to 4, with higher score indicating a worst erythema.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of laser and cream vs laser alone in the clinical improvement of skin lesions as assessed by PGA</measure>
      <time_frame>4, 8, 12, 16 weeks</time_frame>
      <description>Any change of skin lesions on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by 6-point Physician Global Assessment (PGA), ranging from 0 to 5, with higher score indicating a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's satisfaction related to laser and cream vs laser alone in the improvement of skin lesions as assessed by VAS</measure>
      <time_frame>4, 8, 12, 16 weeks</time_frame>
      <description>Any difference of patient's satisfaction for the improvement of skin lesions on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by a 9-point anchored visual analogue scale (VAS), ranging from -4 to +4, with negative scores indicating a worsening of condition, with 0 indicating no difference and with positive scores indicating an improvement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of laser and cream vs laser alone in reducing telangiectasia severity as assessed by TGS</measure>
      <time_frame>4, 8, 12, 16 weeks</time_frame>
      <description>Any change of telangiectasia severity on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by telangiectasia grading scale (TGS), ranging from 0 to 3, with higher score indicating a worst telangiectasia severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of laser and cream vs laser alone in reducing papules and papulopustules</measure>
      <time_frame>4, 8, 12, 16 weeks</time_frame>
      <description>Any change in the number of papules and papulopustules on the side treated with KTP laser and ivermectin 1% cream vs laser alone.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of laser and cream vs laser alone in reducing face swelling as assessed by the patient</measure>
      <time_frame>4, 8, 12, 16 weeks</time_frame>
      <description>Any change in the number of days of face swelling on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of laser and cream vs laser alone in reducing face redness as assessed by the patient</measure>
      <time_frame>4, 8, 12, 16 weeks</time_frame>
      <description>Any change in the number of days of face redness on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of laser and cream vs laser alone in reducing face purpura as assessed by the patient</measure>
      <time_frame>4, 8, 12, 16 weeks</time_frame>
      <description>Any change in the number of days of face purpura on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Incidence of observed side-effects</measure>
      <time_frame>16 weeks</time_frame>
      <description>Cumulative number of observed treatment side-effects.</description>
    </other_outcome>
    <other_outcome>
      <measure>Incidence of observed adverse events</measure>
      <time_frame>16 weeks</time_frame>
      <description>Cumulative number of observed treatment adverse events.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Rosacea</condition>
    <arm_group>
      <arm_group_label>Laser and cream</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Laser alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>KTP laser</intervention_name>
      <description>Treatment with KTP 532 nm laser. Laser fluence depends on erythema intensity and ranges from 7.0 J/cm2 to 11 J/cm2 with a 4-11 mm spot size and 8-12 ms pulse duration.</description>
      <arm_group_label>Laser alone</arm_group_label>
      <arm_group_label>Laser and cream</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ivermectin 1% cream</intervention_name>
      <description>Application of ivermectin 1% cream 1x/day. Interruption for 4 days in case of irritation/redness.</description>
      <arm_group_label>Laser and cream</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Fitzpatrick skin type I-IV&#xD;
  &#xD;
            -  Presence of facial erythematous rosacea or mild papulopustular rosacea with permanent&#xD;
               erythema&#xD;
  &#xD;
            -  Informed consent signed&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of adverse events related to KTP laser therapy&#xD;
  &#xD;
            -  Pregnant or breastfeeding women&#xD;
  &#xD;
            -  Intention to become pregnant during the course of the study&#xD;
  &#xD;
            -  History of intolerance or allergic reaction to ivermectin 1% cream or one of the&#xD;
               ingredients&#xD;
  &#xD;
            -  Ongoing treatment for skin cancer&#xD;
  &#xD;
            -  Ongoing treatment with strong inhibitors of P-glycoprotein (P-gp) and CYP3A4 (e.g.,&#xD;
               itraconazole, voriconazole, posaconazole, clarithromycin, cobicistat)&#xD;
  &#xD;
            -  Ongoing treatment with substances with a narrow therapeutic range whose excretion&#xD;
               depends substantially on P-gp (e.g. digoxin, ciclosporin)&#xD;
  &#xD;
            -  Inability to understand the study content&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kristine Heidemeyer, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital Inselspital, Bern</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kristine Heidemeyer, MD</last_name>
      <phone>316322218</phone>
      <phone_ext>+41</phone_ext>
      <email>Kristine.Heidemeyer@insel.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of dermatology, University Hospital Inselspital, Bern</name>
        <address>
          <city>Bern</city>
          <zip>3010</zip>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rosacea</keyword>
    <keyword>Laser</keyword>
    <keyword>Ivermectin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rosacea</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ivermectin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033352
  org study id: 2023-D0015
  nct id: NCT06033352
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rosacea is a frequent chronic inflammatory disease affecting mainly the face but also eyes
        and scalp. Rosacea is classified into 3 types: erythemato-teleangiectatica, papulopustulosa
        and phymatosa. Treatments depend on the type and include topical and systemic antibiotics,
        azelaic acid, topical ivermectin, topical brimonidine, systemic isotretinoin as well as
        intense pulsed light (IPL) and laser therapies.
  
        For treatment of telangiectasia and redness, laser and IPL therapies are the first choice.
        Vascular lasers, such as pulsed dye lasers (PDL) and potassium-titanyl phosphate (KTP) lasers
        as well as IPL, have demonstrated good efficacy in reduction of erythema and telangiectasias
        in patients with rosacea. However, these treatments are expensive and mostly not covered by
        the health insurance. Therefore, for patients it is important to receive the maximal effect
        and improvement after each single laser session.
  
        Ivermectin is a semi-synthetic derivative of avermectin and has an anti-inflammatory effect
        as well as an antiparasitic effect on demodex mite. The latter is playing an important
        pathogenetic role in rosacea.
  
        This randomized controlled study aims to compare the effect of KTP laser in combination with
        ivermectin 1% cream vs KTP laser alone in patients with facial rosacea.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 1:1 within-patient (split-face) random allocation
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Efficacy of laser and cream vs laser alone in reducing erythema as assessed by NEI
  time frame: 16 weeks
  description: Any relative decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Normalized Erythema Index (NEI), ranging from 0 to 80, with higher values indicating a worst erythema.
  measure: Efficacy of laser and cream vs laser alone in reducing erythema as assessed by SRI
  time frame: 16 weeks
  description: Any relative decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Skin Redness Index (SRI), ranging from 1 to 4, with higher score indicating a worst erythema.
  measure: Efficacy of laser and cream vs laser alone in reducing erythema as assessed by CEA
  time frame: 4, 8, 12, 16 weeks
  description: Any decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Clinical Erythema Assessment (CEA), ranging from 0 to 4, with higher score indicating a worst erythema.
  measure: Efficacy of laser and cream vs laser alone in the clinical improvement of skin lesions as assessed by PGA
  time frame: 4, 8, 12, 16 weeks
  description: Any change of skin lesions on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by 6-point Physician Global Assessment (PGA), ranging from 0 to 5, with higher score indicating a better outcome.
  measure: Patient's satisfaction related to laser and cream vs laser alone in the improvement of skin lesions as assessed by VAS
  time frame: 4, 8, 12, 16 weeks
  description: Any difference of patient's satisfaction for the improvement of skin lesions on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by a 9-point anchored visual analogue scale (VAS), ranging from -4 to +4, with negative scores indicating a worsening of condition, with 0 indicating no difference and with positive scores indicating an improvement.
  measure: Efficacy of laser and cream vs laser alone in reducing telangiectasia severity as assessed by TGS
  time frame: 4, 8, 12, 16 weeks
  description: Any change of telangiectasia severity on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by telangiectasia grading scale (TGS), ranging from 0 to 3, with higher score indicating a worst telangiectasia severity.
  measure: Efficacy of laser and cream vs laser alone in reducing papules and papulopustules
  time frame: 4, 8, 12, 16 weeks
  description: Any change in the number of papules and papulopustules on the side treated with KTP laser and ivermectin 1% cream vs laser alone.
  measure: Efficacy of laser and cream vs laser alone in reducing face swelling as assessed by the patient
  time frame: 4, 8, 12, 16 weeks
  description: Any change in the number of days of face swelling on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient
  measure: Efficacy of laser and cream vs laser alone in reducing face redness as assessed by the patient
  time frame: 4, 8, 12, 16 weeks
  description: Any change in the number of days of face redness on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient.
  measure: Efficacy of laser and cream vs laser alone in reducing face purpura as assessed by the patient
  time frame: 4, 8, 12, 16 weeks
  description: Any change in the number of days of face purpura on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient.
  measure: Incidence of observed side-effects
  time frame: 16 weeks
  description: Cumulative number of observed treatment side-effects.
  measure: Incidence of observed adverse events
  time frame: 16 weeks
  description: Cumulative number of observed treatment adverse events.
  arm group label: Laser and cream
  arm group type: Experimental
  arm group label: Laser alone
  arm group type: Active Comparator
  intervention type: Device
  intervention name: KTP laser
  description: Treatment with KTP 532 nm laser. Laser fluence depends on erythema intensity and ranges from 7.0 J/cm2 to 11 J/cm2 with a 4-11 mm spot size and 8-12 ms pulse duration.
  arm group label: Laser alone
  arm group label: Laser and cream
  intervention type: Drug
  intervention name: Ivermectin 1% cream
  description: Application of ivermectin 1% cream 1x/day. Interruption for 4 days in case of irritation/redness.
  arm group label: Laser and cream
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kristine Heidemeyer, MD
  role: Principal Investigator
  affiliation: University Hospital Inselspital, Bern
  last name: Kristine Heidemeyer, MD
  phone: 316322218
  phone ext: +41
  email: Kristine.Heidemeyer@insel.ch
  facility: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Rosacea
  mesh term: Ivermectin
  sharing ipd: No