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/NCT06032078</url>
    </required_header>
    <id_info>
      <org_study_id>2022-04-376-A-3</org_study_id>
      <nct_id>NCT06032078</nct_id>
    </id_info>
    <brief_title>Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris</brief_title>
    <official_title>Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Premier Specialists, Australia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The University of New South Wales</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Premier Specialists, Australia</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This prospective study aims to evaluate the responsiveness of the validated investigator&#xD;
        global assessment (IGA) and composite area index score for keratosis pilaris by data&#xD;
        collection through treatment and scoring sessions held at a private practice and relevant&#xD;
        statistical analysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective study aiming to evaluate the responsiveness of the IGA score for KP.&#xD;
        KPAI is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs,&#xD;
        trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin&#xD;
        roughness and papulation) and damage (pigmentation and scarring). The final score will be a&#xD;
        maximum of 100. KPIGA, on the other hand, is a standard 0-4 IGA score. A Physician's Global&#xD;
        Assessment Score and a 15-point Likert Scale would also be used by investigators, data&#xD;
        collected act as external anchor for further responsiveness statistical analysis purpose.&#xD;
  &#xD;
        4 scoring sessions will take place at Premier Specialists, Kogarah, Sydney with all&#xD;
        co-investigators conducting the study in person at this single study site. Each dermatologist&#xD;
        and medical professional involved will receive training on using the scores through a&#xD;
        slideshow of training photos prior to the live scoring session. Firstly, a baseline score&#xD;
        will be determined using the proposed scoring systems on the first scoring session. After&#xD;
        that, participants will be offered 3 sessions of Nd: YAG laser 1064nm treatments at 4-week&#xD;
        intervals on the affected skin of all body regions (face, upper limbs, lower limbs, trunk,&#xD;
        and buttocks). The baseline KPIGA and KPAI scores obtained on the first scoring visit acts as&#xD;
        the control for this pilot study and the scores obtained in the 3 progressive visits will be&#xD;
        compared to the baseline. According to relevant study, the recommended Nd: YAG laser 1064nm&#xD;
        treatment regimen is 3 treatment sessions at 4-week intervals. They will be scored before&#xD;
        subsequent treatment sessions to see if there is any improvement in their KP and if the score&#xD;
        is responsive to change.&#xD;
  &#xD;
        Every participant will also complete the DLQI questionnaire during each visit. This data will&#xD;
        be used to provide insight of patient's subjective perceptions of KP and the psychological&#xD;
        impact it may have on them.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 26, 2023</start_date>
    <completion_date type="Anticipated">December 29, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 29, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>15 patients with keratosis pilaris (including subtypes) are recruited</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>KP-IGA</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>KP-IGA is a standard 0-4 IGA score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>KPAI</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>KPAI is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs, trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin roughness and papulation) and damage (pigmentation and scarring). The final score will be a maximum of 100.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Likert Scale of Magnitude of CHange</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>15-point Likert scale from -7 (deterioration) to +7 (improvement)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physician's Global Assessment</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>10-point scale form 0 to 10 showing the worst skin condition to the best</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Keratosis Pilaris</condition>
    <arm_group>
      <arm_group_label>Patients with keratosis pilaris</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients treated with 3 sessions of 1064nm Nd: YAG laser at 4-weekly intervals. Results are compared with baseline.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cutera laser machine</intervention_name>
      <description>1064nm Nd: YAG laser</description>
      <arm_group_label>Patients with keratosis pilaris</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. All genders are allowed to participate&#xD;
  &#xD;
            2. Age range: 18-80 years&#xD;
  &#xD;
            3. Participants with Fitzpatrick skin type 1-3&#xD;
  &#xD;
            4. Those with KP including subtypes of KP on the scored body regions (face, upper limbs,&#xD;
               lower limbs, trunk, and buttocks)&#xD;
  &#xD;
            5. Able to attend the scoring sessions&#xD;
  &#xD;
            6. Participants having read and understood the PICF and are willing to participate&#xD;
  &#xD;
            7. Of mature mind and able to provide informed consent&#xD;
  &#xD;
            8. Able to maintain compliance with required study related procedures including&#xD;
               completing the QOL questionnaire's&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants who are unwilling or unable to attend the scoring sessions&#xD;
  &#xD;
            2. Those with other skin conditions overlapping the same area(s) as the KP&#xD;
  &#xD;
            3. People younger than 18&#xD;
  &#xD;
            4. People with darker skin i.e. Fitzpatrick skin type 4 or above&#xD;
  &#xD;
            5. Those who had received any laser or dermabrasion therapy in the previous 6 months or&#xD;
               topical treatment (keratolytic agents or corticosteroids) in the previous 1 month&#xD;
               before the study treatment session&#xD;
  &#xD;
            6. Those with a history of keloid or hypertrophic scars&#xD;
  &#xD;
            7. Those being on photosensitive medications, allergic to intervention agents&#xD;
  &#xD;
            8. Pregnant or lactating&#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>Premier Dermatology</name>
        <address>
          <city>Sydney</city>
          <state>New South Wales</state>
          <zip>2217</zip>
          <country>Australia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Premier Specialists</name>
        <address>
          <city>Sydney</city>
          <state>New South Wales</state>
          <zip>2217</zip>
          <country>Australia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Premier Specialists, Australia</investigator_affiliation>
      <investigator_full_name>Dedee Murrell</investigator_full_name>
      <investigator_title>Professor Dedee Murrell</investigator_title>
    </responsible_party>
    <keyword>responsiveness</keyword>
    <keyword>investigator global assessment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Keratosis, Actinic</mesh_term>
      <mesh_term>Keratosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All data obtained will be stored securely on-site premises and will not be articulated outside of Australia. Data obtained from patients through scoring sheets and QOL questionnaires will be transcribed as de-identifiable data in an Excel spreadsheet into a password-protected computer (only the investigators with the corresponding study codes given to each patient can identify the data for the purpose of study data analysis). The original scoring sheets and QOL questionnaires will be stored securely on-site and may only be accessed by investigators and co-investigators, as detailed in the patient consent form.</ipd_description>
    </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/NCT06032078
  org study id: 2022-04-376-A-3
  nct id: NCT06032078
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This prospective study aims to evaluate the responsiveness of the validated investigator
        global assessment (IGA) and composite area index score for keratosis pilaris by data
        collection through treatment and scoring sessions held at a private practice and relevant
        statistical analysis.
  This is a prospective study aiming to evaluate the responsiveness of the IGA score for KP.
        KPAI is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs,
        trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin
        roughness and papulation) and damage (pigmentation and scarring). The final score will be a
        maximum of 100. KPIGA, on the other hand, is a standard 0-4 IGA score. A Physician's Global
        Assessment Score and a 15-point Likert Scale would also be used by investigators, data
        collected act as external anchor for further responsiveness statistical analysis purpose.
  
        4 scoring sessions will take place at Premier Specialists, Kogarah, Sydney with all
        co-investigators conducting the study in person at this single study site. Each dermatologist
        and medical professional involved will receive training on using the scores through a
        slideshow of training photos prior to the live scoring session. Firstly, a baseline score
        will be determined using the proposed scoring systems on the first scoring session. After
        that, participants will be offered 3 sessions of Nd: YAG laser 1064nm treatments at 4-week
        intervals on the affected skin of all body regions (face, upper limbs, lower limbs, trunk,
        and buttocks). The baseline KPIGA and KPAI scores obtained on the first scoring visit acts as
        the control for this pilot study and the scores obtained in the 3 progressive visits will be
        compared to the baseline. According to relevant study, the recommended Nd: YAG laser 1064nm
        treatment regimen is 3 treatment sessions at 4-week intervals. They will be scored before
        subsequent treatment sessions to see if there is any improvement in their KP and if the score
        is responsive to change.
  
        Every participant will also complete the DLQI questionnaire during each visit. This data will
        be used to provide insight of patient's subjective perceptions of KP and the psychological
        impact it may have on them.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: 15 patients with keratosis pilaris (including subtypes) are recruited
  primary purpose: Other
  masking: None (Open Label)
  measure: KP-IGA
  time frame: through study completion, an average of 1 year
  description: KP-IGA is a standard 0-4 IGA score.
  measure: KPAI
  time frame: through study completion, an average of 1 year
  description: KPAI is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs, trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin roughness and papulation) and damage (pigmentation and scarring). The final score will be a maximum of 100.
  measure: Likert Scale of Magnitude of CHange
  time frame: through study completion, an average of 1 year
  description: 15-point Likert scale from -7 (deterioration) to +7 (improvement)
  measure: Physician's Global Assessment
  time frame: through study completion, an average of 1 year
  description: 10-point scale form 0 to 10 showing the worst skin condition to the best
  arm group label: Patients with keratosis pilaris
  arm group type: Experimental
  description: Patients treated with 3 sessions of 1064nm Nd: YAG laser at 4-weekly intervals. Results are compared with baseline.
  intervention type: Device
  intervention name: Cutera laser machine
  description: 1064nm Nd: YAG laser
  arm group label: Patients with keratosis pilaris
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  facility: 
  country: Australia
  responsible party type: Principal Investigator
  investigator affiliation: Premier Specialists, Australia
  investigator full name: Dedee Murrell
  investigator title: Professor Dedee Murrell
  mesh term: Keratosis, Actinic
  mesh term: Keratosis
  sharing ipd: No
  ipd description: All data obtained will be stored securely on-site premises and will not be articulated outside of Australia. Data obtained from patients through scoring sheets and QOL questionnaires will be transcribed as de-identifiable data in an Excel spreadsheet into a password-protected computer (only the investigators with the corresponding study codes given to each patient can identify the data for the purpose of study data analysis). The original scoring sheets and QOL questionnaires will be stored securely on-site and may only be accessed by investigators and co-investigators, as detailed in the patient consent form.