<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/NCT01666509</url>
  </required_header>
  <id_info>
    <org_study_id>CL-068-IV-01</org_study_id>
    <nct_id>NCT01666509</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability of Topical Rossoseq™ Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)</brief_title>
  <official_title>A Post Marketing Clinical Follow-up, Randomised, Double-blind Study Comparing the Efficacy and Tolerability of Topical Rossoseq™ With Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PBB Entrepreneur Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PBB Entrepreneur Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rossoseq™ is registered for the treatment of inflammatory skin conditions. Rosacea is one&#xD;
      such inflammatory skin disorder that has not been studied yet for the use of Rossoseq™.&#xD;
      Whilst rosacea is showing features of an inflammatory skin disorder [1], particularly stage 1&#xD;
      is poorly understood and treatment options are limited and therefore this study - within the&#xD;
      target indication - will contribute to the learning about rosacea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Male or female subjects ≥18 and &lt; 85 years with a clinically diagnosed rosacea subtype 1&#xD;
      (erythematotelangiectatic) defined by a score of 6-15 for the primary and secondary features&#xD;
      of the rosacea standard grading system (RSGS; Wilkin et al, 2004) will be enrolled.&#xD;
&#xD;
      The study will consist of a Screening visit, Baseline visit (Week 0), a telephone call at&#xD;
      Week 1, visits at Week 2 and 4, and a follow-up telephone call at Week 5. Eligible subjects&#xD;
      may or may not be using medication for their rosacea at the time of screening. Subjects with&#xD;
      concomitant use of rosacea treatments will be taken off their current medication and will&#xD;
      return for a Baseline Visit at the end of the wash-out period.&#xD;
&#xD;
      Eligible subjects will be stratified by gender at a ratio of 4:1 (Female: Male). Within the&#xD;
      strata, subjects will be randomised at Baseline in a 2:1 ratio in favour of Rossoseq™ to&#xD;
      receive either Rossoseq™ or vehicle.&#xD;
&#xD;
      Efficacy will be evaluated using subject rating of the rosacea specific quality of life&#xD;
      instrument (R-QOL; Nicholson et al, 2007) during office visits and applied over the phone&#xD;
      during the week 1 and follow-up telephone call at Week 5. An investigator rating will be&#xD;
      performed using a &quot;0=absent&quot; to &quot;3=severe&quot; grading of the RSGS primary features flushing,&#xD;
      nontransient erythema, papules and pustules, telangiectasia and the secondary features&#xD;
      burning or stinging, plaques, dry appearance, edema, ocular manifestations and phymatous&#xD;
      changes during the office visits. Ocular manifestations and phymatous changes need to be&#xD;
      absent to be eligible for the study.&#xD;
&#xD;
      Photographs to document treatment effects will be taken at screening, baseline, week 2 and&#xD;
      week 4.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom construct of the R-QOL</measure>
    <time_frame>Change from baseline to Week 4</time_frame>
    <description>The symptom construct contains 7 symptom related items scored by the subject as ''never'', ''rarely'', ''sometimes'', ''often'' or ''all the time''. The responses are recorded on a 1 (never)-to-5 (all the time) scale. A subject's score is the average of his or her responses to the items in the construct (1-5).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total R-QOL</measure>
    <time_frame>Change from baseline to Week 4</time_frame>
    <description>The total R-QOL is the average of all responses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function construct of the R-QOL</measure>
    <time_frame>Change from baseline to Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion construct of the R-QOL</measure>
    <time_frame>Change from baseline to Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total RSGS score</measure>
    <time_frame>Change from baseline to Week 4</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Rosacea Subtype 1 (Erythematotelangiectatic)</condition>
  <arm_group>
    <arm_group_label>Rossoseq™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gel, topically applied twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Gel, topically applied twice</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rossoseq™</intervention_name>
    <arm_group_label>Rossoseq™</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated informed consent prior to any study-mandated procedure&#xD;
&#xD;
          -  Clinically diagnosed rosacea defined by a score of ≥6 and ≤15 out of a maximum score&#xD;
             of 30 for the primary and secondary features of the RSGS&#xD;
&#xD;
          -  Female subjects of childbearing potential must be using appropriate birth control&#xD;
&#xD;
        Main exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Women with the following menopausal symptoms within the last two years prior to&#xD;
             screening: excessive sweating, flushing, mood changes&#xD;
&#xD;
          -  Ocular manifestations of rosacea&#xD;
&#xD;
          -  Peripheral location(s) of rosacea&#xD;
&#xD;
          -  Phymatous changes&#xD;
&#xD;
          -  Severe facial skin dryness or xerosis&#xD;
&#xD;
          -  Keratoconjunctivitis sicca&#xD;
&#xD;
          -  Flushing due to conditions other than rosacea&#xD;
&#xD;
          -  Any other abnormal facial skin conditions, e.g., eczema, perioral dermatitis, broken&#xD;
             and bleeding skin on area of application&#xD;
&#xD;
          -  Malignancy within the past 2 years with the exception of in situ removal of basal cell&#xD;
             carcinoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Study site 5</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study site 2</name>
      <address>
        <city>Duelmen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 1</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study site 4</name>
      <address>
        <city>Paderborn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>January 4, 2013</last_update_submitted>
  <last_update_submitted_qc>January 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2013</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>Rosacea</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/NCT01666509
org study id: CL-068-IV-01
nct id: NCT01666509
lead sponsor: 
has dmc: No
Rossoseq™ is registered for the treatment of inflammatory skin conditions. Rosacea is one
      such inflammatory skin disorder that has not been studied yet for the use of Rossoseq™.
      Whilst rosacea is showing features of an inflammatory skin disorder [1], particularly stage 1
      is poorly understood and treatment options are limited and therefore this study - within the
      target indication - will contribute to the learning about rosacea.
Male or female subjects ≥18 and < 85 years with a clinically diagnosed rosacea subtype 1
      (erythematotelangiectatic) defined by a score of 6-15 for the primary and secondary features
      of the rosacea standard grading system (RSGS; Wilkin et al, 2004) will be enrolled.

      The study will consist of a Screening visit, Baseline visit (Week 0), a telephone call at
      Week 1, visits at Week 2 and 4, and a follow-up telephone call at Week 5. Eligible subjects
      may or may not be using medication for their rosacea at the time of screening. Subjects with
      concomitant use of rosacea treatments will be taken off their current medication and will
      return for a Baseline Visit at the end of the wash-out period.

      Eligible subjects will be stratified by gender at a ratio of 4:1 (Female: Male). Within the
      strata, subjects will be randomised at Baseline in a 2:1 ratio in favour of Rossoseq™ to
      receive either Rossoseq™ or vehicle.

      Efficacy will be evaluated using subject rating of the rosacea specific quality of life
      instrument (R-QOL; Nicholson et al, 2007) during office visits and applied over the phone
      during the week 1 and follow-up telephone call at Week 5. An investigator rating will be
      performed using a "0=absent" to "3=severe" grading of the RSGS primary features flushing,
      nontransient erythema, papules and pustules, telangiectasia and the secondary features
      burning or stinging, plaques, dry appearance, edema, ocular manifestations and phymatous
      changes during the office visits. Ocular manifestations and phymatous changes need to be
      absent to be eligible for the study.

      Photographs to document treatment effects will be taken at screening, baseline, week 2 and
      week 4.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Symptom construct of the R-QOL
time frame: Change from baseline to Week 4
description: The symptom construct contains 7 symptom related items scored by the subject as ''never'', ''rarely'', ''sometimes'', ''often'' or ''all the time''. The responses are recorded on a 1 (never)-to-5 (all the time) scale. A subject's score is the average of his or her responses to the items in the construct (1-5).
measure: Total R-QOL
time frame: Change from baseline to Week 4
description: The total R-QOL is the average of all responses
measure: Function construct of the R-QOL
time frame: Change from baseline to Week 4
measure: Emotion construct of the R-QOL
time frame: Change from baseline to Week 4
measure: Total RSGS score
time frame: Change from baseline to Week 4
arm group label: Rossoseq™
arm group type: Experimental
description: Gel, topically applied twice daily
arm group label: Vehicle
arm group type: Placebo Comparator
description: Gel, topically applied twice
intervention type: Device
intervention name: Rossoseq™
arm group label: Rossoseq™
intervention type: Device
intervention name: Placebo
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Rosacea