<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/NCT04461366</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/002410</org_study_id>
    <nct_id>NCT04461366</nct_id>
  </id_info>
  <brief_title>Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars</brief_title>
  <acronym>MRFPDL</acronym>
  <official_title>Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background: The acne scar is a common disorder characterized by skin eruption or&#xD;
      abnormalities on face, chest, and/or back in the adolescence which affect the cosmetic&#xD;
      appearance.&#xD;
&#xD;
      Purpose: The main aim of this study was to investigate whether monopolar radiofrequency (MRF)&#xD;
      or pulsed dye laser (PDL) is more effective in the cases suffering from acne scars in the&#xD;
      form of reducing acne scars and improving the cosmetic appearance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty patients suffering from moderate or severe acne scars were randomly assigned into two&#xD;
      equal groups. Group A (MRF group): received 2 sessions per week with MRF for 8 weeks. Group B&#xD;
      (PDL group): received 1 session per week with PDL for 8 weeks. The severity of acne scars was&#xD;
      assessed before and after treatment by using the clinical evaluation scale for acne scarring&#xD;
      (ECCA) scale and the self-assessment of clinical acne-related scars (SCARS) scale. Quality of&#xD;
      life and the emotional impact of acne scars were evaluated by the facial acne scar quality of&#xD;
      life (FASQoL) scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>acne scars severity by investigator</measure>
    <time_frame>after 8 weeks of intervention</time_frame>
    <description>Clinical evaluation scale for acne scarring. Using this scale, the type of scar was defined by the qualitative descriptions of scars, which is then accompanied by a numerical score (0-4) and then multiplied by (15-50) which is a weighting factor of clinical severity, the total possible score is from 0 to 540. Higher score means worse outcome while lower score means better out come.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>acne scars severity by the participant</measure>
    <time_frame>after 8 weeks of intervention</time_frame>
    <description>Self-assessment of clinical acne-related scars questionnaire. It consists of 5-items with 1 hypothesized domain which asks patients to assess acne scars severity as seen in the mirror. The total possible score is from 0- 20. Higher score means worse outcome while lower score means better out come.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>emotional, social functioning and work/school effect of scars</measure>
    <time_frame>after 8 weeks of intervention</time_frame>
    <description>Facial acne scar quality of life scale. It is a tool formed of 10-items with 3 domains to assess the emotional, social functioning and work/school effect of scars on a 5-point rating scale The total possible score is from 0- 40. Higher score means worse outcome while lower score means better out come.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Acne Atrophica</condition>
  <arm_group>
    <arm_group_label>monopolar radiofrequency (MRF) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monopolar Radiofrequency Diathermy (LVT-250, Korea) was used at average energy160-180 W, main power 50/60 Hz, 40˚C ~ 45˚C Temperature, RF output 470 kHz, 20 mm electrode size.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulsed dye laser (PDL) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Flash lamp pulsed dye laser; Candela SPTL-1 (Candela Corp., Wayland, Mass.) with the following parameters: (585nm wavelength, 450 msec pulse duration, 6.5 to 7.5 J/cm² energy density and 5or 7mm spot size).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monopolar radiofrequency</intervention_name>
    <description>The RF electrode was moved randomly for 30 seconds over each scar. The total duration of the treatment session is only 5 minutes for each cheek. It takes 15 minutes if the forehead and 2 cheeks are affected.</description>
    <arm_group_label>monopolar radiofrequency (MRF) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulsed dye laser</intervention_name>
    <description>PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.</description>
    <arm_group_label>Pulsed dye laser (PDL) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with mild to severe acne scar&#xD;
&#xD;
          -  Patients with acne scar in the face&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers and alcohol drinker&#xD;
&#xD;
          -  Patients who had a history of diabetes, circulatory or sensory disorders&#xD;
&#xD;
          -  Patients who had a history of frequent sunburns&#xD;
&#xD;
          -  Patients with nodulocystic acne&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>adolescents</gender_description>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nesma M Allam, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>lecturer at faculty of physical therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radwa T Elshorbagy</name>
      <address>
        <city>Giza</city>
        <zip>12111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nesma Morgan Allam</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Acne scars</keyword>
  <keyword>Monopolar radiofrequency</keyword>
  <keyword>Pulsed dye laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>I will share data 6 months after publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>6 months after publication</ipd_time_frame>
    <ipd_access_criteria>study protocol</ipd_access_criteria>
  </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/NCT04461366
org study id: P.T.REC/012/002410
nct id: NCT04461366
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: The acne scar is a common disorder characterized by skin eruption or
      abnormalities on face, chest, and/or back in the adolescence which affect the cosmetic
      appearance.

      Purpose: The main aim of this study was to investigate whether monopolar radiofrequency (MRF)
      or pulsed dye laser (PDL) is more effective in the cases suffering from acne scars in the
      form of reducing acne scars and improving the cosmetic appearance.
Thirty patients suffering from moderate or severe acne scars were randomly assigned into two
      equal groups. Group A (MRF group): received 2 sessions per week with MRF for 8 weeks. Group B
      (PDL group): received 1 session per week with PDL for 8 weeks. The severity of acne scars was
      assessed before and after treatment by using the clinical evaluation scale for acne scarring
      (ECCA) scale and the self-assessment of clinical acne-related scars (SCARS) scale. Quality of
      life and the emotional impact of acne scars were evaluated by the facial acne scar quality of
      life (FASQoL) scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: acne scars severity by investigator
time frame: after 8 weeks of intervention
description: Clinical evaluation scale for acne scarring. Using this scale, the type of scar was defined by the qualitative descriptions of scars, which is then accompanied by a numerical score (0-4) and then multiplied by (15-50) which is a weighting factor of clinical severity, the total possible score is from 0 to 540. Higher score means worse outcome while lower score means better out come.
measure: acne scars severity by the participant
time frame: after 8 weeks of intervention
description: Self-assessment of clinical acne-related scars questionnaire. It consists of 5-items with 1 hypothesized domain which asks patients to assess acne scars severity as seen in the mirror. The total possible score is from 0- 20. Higher score means worse outcome while lower score means better out come.
measure: emotional, social functioning and work/school effect of scars
time frame: after 8 weeks of intervention
description: Facial acne scar quality of life scale. It is a tool formed of 10-items with 3 domains to assess the emotional, social functioning and work/school effect of scars on a 5-point rating scale The total possible score is from 0- 40. Higher score means worse outcome while lower score means better out come.
arm group label: monopolar radiofrequency (MRF) group
arm group type: Experimental
description: Monopolar Radiofrequency Diathermy (LVT-250, Korea) was used at average energy160-180 W, main power 50/60 Hz, 40˚C ~ 45˚C Temperature, RF output 470 kHz, 20 mm electrode size.
arm group label: Pulsed dye laser (PDL) group
arm group type: Active Comparator
description: Flash lamp pulsed dye laser; Candela SPTL-1 (Candela Corp., Wayland, Mass.) with the following parameters: (585nm wavelength, 450 msec pulse duration, 6.5 to 7.5 J/cm² energy density and 5or 7mm spot size).
intervention type: Device
intervention name: Monopolar radiofrequency
description: The RF electrode was moved randomly for 30 seconds over each scar. The total duration of the treatment session is only 5 minutes for each cheek. It takes 15 minutes if the forehead and 2 cheeks are affected.
arm group label: monopolar radiofrequency (MRF) group
intervention type: Device
intervention name: Pulsed dye laser
description: PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.
arm group label: Pulsed dye laser (PDL) group
criteria: 
gender: All
gender based: Yes
gender description: adolescents
minimum age: 19 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nesma M Allam, PhD
role: Principal Investigator
affiliation: lecturer at faculty of physical therapy
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nesma Morgan Allam
investigator title: Lecturer
mesh term: Acne Vulgaris
sharing ipd: Yes
ipd description: I will share data 6 months after publication
ipd info type: Study Protocol
ipd time frame: 6 months after publication
ipd access criteria: study protocol