<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/NCT02204254</url>
  </required_header>
  <id_info>
    <org_study_id>13-AOI-13</org_study_id>
    <nct_id>NCT02204254</nct_id>
  </id_info>
  <brief_title>RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea</brief_title>
  <acronym>Rosac-RF</acronym>
  <official_title>Prospective, Open Label, Randomized Study Comparing Bipolar Radiofrequency Potentiated by Infrared Light to Doxycycline in Patient With Papulopustular Rosacea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rosacea is a chronic facial disfiguring dermatosis characterized by different stages like&#xD;
      flushing, erythema, telangiectasia and papulo-pustular lesions. Recommended treatments&#xD;
      include topical (metronidazole) and systemic (doxycycline) antibiotics with only a suspensive&#xD;
      effect. The bipolar radiofrequency (RF) with Elos system (infrared light) is a device&#xD;
      emitting an electromagnetic current inducing an increase in temperature when applied on the&#xD;
      skin, potentiated by infrared light. The monopolar RF has already been used in rosacea on a&#xD;
      small number of cases with positive and prolonged results. RF with Elos system has been&#xD;
      evaluated on erythemato-telangiectasic rosacea with encouraging results. Demodex folliculorum&#xD;
      (DF) is a long transparent mite which asymptomatically parasitizes pilosebaceous follicle of&#xD;
      normal human skin sometimes responsible of inflammatory facial dermatoses. The prevalence and&#xD;
      density of DF are increased in rosacea, and DF is suspected to play a role in the&#xD;
      pathogenesis of rosacea. DF is sensitive to heat, and the investigators hypothesize that&#xD;
      radiofrequency treatment may affect the survival of the mite and should be effective to treat&#xD;
      papulopustular rosacea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">June 7, 2021</completion_date>
  <primary_completion_date type="Actual">April 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percent of patients with a score of 0 or 1 severity of rosacea (absent or mild) on a scale of 0-3 (Physician Global Assessment)</measure>
    <time_frame>at 6 months</time_frame>
    <description>The primary endpoint is the percent of patients with a score of 0 or 1 severity of rosacea (absent or mild) on a scale of 0-3 (Physician Global Assessment) evaluated on photographs by an independent investigator.&#xD;
Inflammatory lesions are considered for the evaluation of PGA because it is not expected that the compared treatments improve erythema and telangectasia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>scorecard score</measure>
    <time_frame>at 6 months</time_frame>
    <description>a) inflammatory lesions count will be assessed on the cheeks. The rate of lesions reduced is the ratio: b ) other symptoms will be achieved by the assessment of erythema (0-3 ) and telangiectasia (score 0-3 ) in the scorecard score.&#xD;
c ) The patient satisfaction will be assessed by a Visual Analogue Scale (VAS) .&#xD;
d) The evaluation of the density of demodex will be assessed on the skin surface biopsy ( SSSB ) and by confocal microscopy ( MCIV ) e ) The skin temperature during radiofrequency sessions will be reported by infrared thermometer skin temperature during the treatment session RF</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Rosacea</condition>
  <arm_group>
    <arm_group_label>Radiofrequence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 sessions of radiofrequency at 3 weeks intervals V1, V2 (W3 or W4) and V3 (between W6 and W8), with clinical examination, evaluation of tolerance, adverse events report, photos, surface biopsy (SSSB), and confocal microscopy (V1 and V3). Follow up visit V4 (M6) with clinical evaluation, photos, SSSB, confocal microscopy, adverse events report and treatment satisfaction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Doxycycline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>doxycycline 100 mg / day for 3 months with clinical evaluation, photos, and confocal SSSB V1 and V4 (M6). Tour V2 M1 for clinical evaluation of safety review, collection of adverse events and issuing end of treatment. Visit V3 M3 on adverse effects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Radiofrequence</intervention_name>
    <description>Associated to arm radiofrequence</description>
    <arm_group_label>Radiofrequence</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxycycline</intervention_name>
    <description>doxycycline 100 mg / day for 3 months with clinical evaluation, photos, and confocal SSSB V1 and V4 (M6). Tour V2 M1 for clinical evaluation of safety review, collection of adverse events and issuing end of treatment. Visit V3 M3 on adverse effects.</description>
    <arm_group_label>Doxycycline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be between 18-70 years old&#xD;
&#xD;
          -  Subjects with papulopustular rosacea graded moderate to severe (2 or 3) according to&#xD;
             the physician global Assessment, and with lesions on the cheeks.&#xD;
&#xD;
          -  Prior stop of any topical treatment antibiotic, retinoid, corticoid or other topical&#xD;
             treatment for rosacea at least 1 month before the start of the study&#xD;
&#xD;
          -  Prior stop of any systemic treatment (antibiotic) two month before the start of the&#xD;
             study and for isotretinoin at least 6 months&#xD;
&#xD;
          -  Last laser treatment, by lamp, laser or LED, at least 3 months before the start of the&#xD;
             study&#xD;
&#xD;
          -  Subjects must be abble to lie for more than 30 minutes&#xD;
&#xD;
          -  Patient able to understand and sign the informed consent form&#xD;
&#xD;
          -  Affiliation to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of child bearing/reproductive potential&#xD;
&#xD;
          -  Other skin disease or abnormality of the face which could interfere with the&#xD;
             evaluation of the different criteria evaluated or with the realization of the RF&#xD;
&#xD;
          -  Contraindications to radiofrequency: presence of a defibrillator or pacemaker, dental&#xD;
             on the cheeks, dental equipment or metallic orthopedic next to the treated area, skin&#xD;
             cancer on the face, progressive systemic disease, uncontrolled hypertension&#xD;
&#xD;
          -  Immunosuppression by HIV (determined by examination) or treatment with&#xD;
             immunosuppressive&#xD;
&#xD;
          -  Tattoos or permanent makeup on the face&#xD;
&#xD;
          -  Excessively tanned skin to sunlight, ultraviolet or with tanning creams during the&#xD;
             last 2 weeks&#xD;
&#xD;
          -  Subject carrying cochlear implants or open wound or in the process of healing&#xD;
&#xD;
          -  Minor patient or under tutorship&#xD;
&#xD;
          -  Cyanoacrylate or doxycycline allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Le Duff Florence, Ph</last_name>
    <role>Principal Investigator</role>
    <affiliation>CRC, Hôpital Archet, 151 route de saint-antoine de ginestière 06200 Nice</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRC, Hôpital de l'Archet, 151 route de saint-ginestière</name>
      <address>
        <city>Nice</city>
        <state>Alpes-maritimes</state>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>March 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxycycline</mesh_term>
  </intervention_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/NCT02204254
org study id: 13-AOI-13
nct id: NCT02204254
lead sponsor: 
has dmc: No
Rosacea is a chronic facial disfiguring dermatosis characterized by different stages like
      flushing, erythema, telangiectasia and papulo-pustular lesions. Recommended treatments
      include topical (metronidazole) and systemic (doxycycline) antibiotics with only a suspensive
      effect. The bipolar radiofrequency (RF) with Elos system (infrared light) is a device
      emitting an electromagnetic current inducing an increase in temperature when applied on the
      skin, potentiated by infrared light. The monopolar RF has already been used in rosacea on a
      small number of cases with positive and prolonged results. RF with Elos system has been
      evaluated on erythemato-telangiectasic rosacea with encouraging results. Demodex folliculorum
      (DF) is a long transparent mite which asymptomatically parasitizes pilosebaceous follicle of
      normal human skin sometimes responsible of inflammatory facial dermatoses. The prevalence and
      density of DF are increased in rosacea, and DF is suspected to play a role in the
      pathogenesis of rosacea. DF is sensitive to heat, and the investigators hypothesize that
      radiofrequency treatment may affect the survival of the mite and should be effective to treat
      papulopustular rosacea.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: percent of patients with a score of 0 or 1 severity of rosacea (absent or mild) on a scale of 0-3 (Physician Global Assessment)
time frame: at 6 months
description: The primary endpoint is the percent of patients with a score of 0 or 1 severity of rosacea (absent or mild) on a scale of 0-3 (Physician Global Assessment) evaluated on photographs by an independent investigator.
Inflammatory lesions are considered for the evaluation of PGA because it is not expected that the compared treatments improve erythema and telangectasia.
measure: scorecard score
time frame: at 6 months
description: a) inflammatory lesions count will be assessed on the cheeks. The rate of lesions reduced is the ratio: b ) other symptoms will be achieved by the assessment of erythema (0-3 ) and telangiectasia (score 0-3 ) in the scorecard score.
c ) The patient satisfaction will be assessed by a Visual Analogue Scale (VAS) .
d) The evaluation of the density of demodex will be assessed on the skin surface biopsy ( SSSB ) and by confocal microscopy ( MCIV ) e ) The skin temperature during radiofrequency sessions will be reported by infrared thermometer skin temperature during the treatment session RF
arm group label: Radiofrequence
arm group type: Experimental
description: 3 sessions of radiofrequency at 3 weeks intervals V1, V2 (W3 or W4) and V3 (between W6 and W8), with clinical examination, evaluation of tolerance, adverse events report, photos, surface biopsy (SSSB), and confocal microscopy (V1 and V3). Follow up visit V4 (M6) with clinical evaluation, photos, SSSB, confocal microscopy, adverse events report and treatment satisfaction.
arm group label: Doxycycline
arm group type: Placebo Comparator
description: doxycycline 100 mg / day for 3 months with clinical evaluation, photos, and confocal SSSB V1 and V4 (M6). Tour V2 M1 for clinical evaluation of safety review, collection of adverse events and issuing end of treatment. Visit V3 M3 on adverse effects.
intervention type: Device
intervention name: Radiofrequence
description: Associated to arm radiofrequence
arm group label: Radiofrequence
intervention type: Drug
intervention name: Doxycycline
description: doxycycline 100 mg / day for 3 months with clinical evaluation, photos, and confocal SSSB V1 and V4 (M6). Tour V2 M1 for clinical evaluation of safety review, collection of adverse events and issuing end of treatment. Visit V3 M3 on adverse effects.
arm group label: Doxycycline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Le Duff Florence, Ph
role: Principal Investigator
affiliation: CRC, Hôpital Archet, 151 route de saint-antoine de ginestière 06200 Nice
facility: 
country: France
responsible party type: Sponsor
mesh term: Rosacea
mesh term: Doxycycline