<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/NCT03779295</url>
  </required_header>
  <id_info>
    <org_study_id>1803028429</org_study_id>
    <nct_id>NCT03779295</nct_id>
  </id_info>
  <brief_title>Laser Therapy for Perioral Dermatitis</brief_title>
  <official_title>Laser Therapy for Perioral Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Perioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral&#xD;
      dermatitis is unknown. Current treatment methods include oral antibiotics and topical&#xD;
      calcenurin inhibitors, both of which produce side effects and have been relatively&#xD;
      ineffective in the treatment of perioral dermatitis. The investigators hope to assess the&#xD;
      efficacy of laser therapy in treatment of perioral dermatitis by using laser therapy on one&#xD;
      half of the patients face and having patients apply topical medication (clindamycin) to their&#xD;
      face for 8 weeks. The side of their face that receives laser therapy will be randomized. The&#xD;
      investigators will assess the efficacy of laser therapy by counting the number of lesions&#xD;
      that patients have before and after laser therapy, comparing photos of patient's perioral&#xD;
      dermatitis before and after treatment, and having patient's rate their satisfaction of the&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No subjects enrolled.&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">June 5, 2019</completion_date>
  <primary_completion_date type="Actual">June 5, 2019</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>This will be a split face prospective trial. The face will be treated in halves. The halves will be randomized to receive topical clindamycin or PDL therapy and clindamycin. Both halves of the face will be treated with topical clindamycin. Per randomization, half of the face will be treated with pulse dye laser therapy at 595 nm, using 6.5 J/cm2, 10 mm spot size and a 6 millisecond pulse width.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The investigators will not remind the participant or other investigators which side of the face received laser therapy, however the investigators cannot completely &quot;blind&quot; either the participant or other investigators as they will be awake or performing the therapy, respectively.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of lesions on side of the subject's face receiving laser therapy</measure>
    <time_frame>initial study visit</time_frame>
    <description>counting number of lesions on each side of the face</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of lesions on side of the subject's face receiving laser therapy</measure>
    <time_frame>4 weeks</time_frame>
    <description>counting number of lesions on each side of the face</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of lesions on side of the subject's face receiving laser therapy</measure>
    <time_frame>8 weeks</time_frame>
    <description>counting number of lesions on each side of the face</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)</measure>
    <time_frame>initial study visit</time_frame>
    <description>counting number of lesions on each side of the face</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)</measure>
    <time_frame>4 weeks</time_frame>
    <description>counting number of lesions on each side of the face</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)</measure>
    <time_frame>8 weeks</time_frame>
    <description>counting number of lesions on each side of the face</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient opinion of side that improved more</measure>
    <time_frame>4 weeks</time_frame>
    <description>Patients will grade satisfaction of treatment by answering &quot;Which side of their face improved more from treatment?&quot; with the option of responding &quot;the right side/the left side/they are the same.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient opinion of side that improved more</measure>
    <time_frame>8 weeks</time_frame>
    <description>Patients will grade satisfaction of treatment by answering &quot;Which side of their face improved more from treatment?&quot; with the option of responding &quot;the right side/the left side/they are the same.&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Perioral Dermatitis</condition>
  <arm_group>
    <arm_group_label>Pulse laser therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clindamycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clindamycin only applied to side of face that does not receive pulse laser therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)</intervention_name>
    <description>The face will be split and randomized, one half will receive pulsed laser dye therapy.</description>
    <arm_group_label>Pulse laser therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clindamycin</intervention_name>
    <description>The entire face (both halves) will receive clindamycin.</description>
    <arm_group_label>Clindamycin</arm_group_label>
    <arm_group_label>Pulse laser therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 years or older&#xD;
&#xD;
          -  perioral dermatitis for greater than 1 month&#xD;
&#xD;
          -  willing to return for follow-up visits 2 weeks, 4 weeks and 8 weeks following&#xD;
             treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  skin type V or VI (due to risk of hyperpigmentation)&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  breastfeeding&#xD;
&#xD;
          -  unable to understand English&#xD;
&#xD;
          -  mentally impaired&#xD;
&#xD;
          -  incarcerated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>West Virginia University University Town Centre Dermatology Clinic</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>Erica Ghareeb</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>perioral dermatitis</keyword>
  <keyword>laser therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Dermatitis, Perioral</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
  </intervention_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/NCT03779295
org study id: 1803028429
nct id: NCT03779295
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Perioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral
      dermatitis is unknown. Current treatment methods include oral antibiotics and topical
      calcenurin inhibitors, both of which produce side effects and have been relatively
      ineffective in the treatment of perioral dermatitis. The investigators hope to assess the
      efficacy of laser therapy in treatment of perioral dermatitis by using laser therapy on one
      half of the patients face and having patients apply topical medication (clindamycin) to their
      face for 8 weeks. The side of their face that receives laser therapy will be randomized. The
      investigators will assess the efficacy of laser therapy by counting the number of lesions
      that patients have before and after laser therapy, comparing photos of patient's perioral
      dermatitis before and after treatment, and having patient's rate their satisfaction of the
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a split face prospective trial. The face will be treated in halves. The halves will be randomized to receive topical clindamycin or PDL therapy and clindamycin. Both halves of the face will be treated with topical clindamycin. Per randomization, half of the face will be treated with pulse dye laser therapy at 595 nm, using 6.5 J/cm2, 10 mm spot size and a 6 millisecond pulse width.
primary purpose: Treatment
masking: Single (Participant)
masking description: The investigators will not remind the participant or other investigators which side of the face received laser therapy, however the investigators cannot completely "blind" either the participant or other investigators as they will be awake or performing the therapy, respectively.
measure: Change in number of lesions on side of the subject's face receiving laser therapy
time frame: initial study visit
description: counting number of lesions on each side of the face
measure: Change in number of lesions on side of the subject's face receiving laser therapy
time frame: 4 weeks
description: counting number of lesions on each side of the face
measure: Change in number of lesions on side of the subject's face receiving laser therapy
time frame: 8 weeks
description: counting number of lesions on each side of the face
measure: Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
time frame: initial study visit
description: counting number of lesions on each side of the face
measure: Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
time frame: 4 weeks
description: counting number of lesions on each side of the face
measure: Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)
time frame: 8 weeks
description: counting number of lesions on each side of the face
measure: Patient opinion of side that improved more
time frame: 4 weeks
description: Patients will grade satisfaction of treatment by answering "Which side of their face improved more from treatment?" with the option of responding "the right side/the left side/they are the same."
measure: Patient opinion of side that improved more
time frame: 8 weeks
description: Patients will grade satisfaction of treatment by answering "Which side of their face improved more from treatment?" with the option of responding "the right side/the left side/they are the same."
arm group label: Pulse laser therapy
arm group type: Experimental
description: Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin
arm group label: Clindamycin
arm group type: Experimental
description: Clindamycin only applied to side of face that does not receive pulse laser therapy.
intervention type: Device
intervention name: Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)
description: The face will be split and randomized, one half will receive pulsed laser dye therapy.
arm group label: Pulse laser therapy
intervention type: Drug
intervention name: Clindamycin
description: The entire face (both halves) will receive clindamycin.
arm group label: Clindamycin
arm group label: Pulse laser therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: West Virginia University
investigator full name: Erica Ghareeb
investigator title: Assistant Professor
mesh term: Dermatitis
mesh term: Dermatitis, Perioral
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate
sharing ipd: No