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/NCT05982613</url>
    </required_header>
    <id_info>
      <org_study_id>UIDV</org_study_id>
      <nct_id>NCT05982613</nct_id>
    </id_info>
    <brief_title>Effectiveness of Standard Therapy of Acne Vulgaris</brief_title>
    <official_title>Effectiveness of Standard Therapy of Acne Vulgaris Based on Clinical Practice Guidelines (CPG) in Indonesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ministry of Education, Culture, Research, and Technology of the Republic of Indonesia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Indonesia University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study was to evaluate the effectiveness of standard therapy for acne vulgaris (AV) based&#xD;
        on the clinical practice guidelines (CPG) in Indonesia. The main questions it aims to answer&#xD;
        were:&#xD;
  &#xD;
          1. How is the clinical characteristics of patients with AV in dr.Cipto Mangunkusumo&#xD;
             Hospital?&#xD;
  &#xD;
          2. How is the effectiveness of standard therapy for AV based on the CPG in Indonesia in&#xD;
             reducing the number of non-inflammatory, inflammatory, and total lesions and degree of&#xD;
             acne severity?&#xD;
  &#xD;
        The clinical pratice guideline (CPG) used for analysis was CPG by dr.Cipto Mangunkusumo&#xD;
        Hospital 2017 in line with the date of patient visit. Data of 724 patients with AV in&#xD;
        dr.Cipto Mangunkusumo Hospital as recorded in the medical records were assessed for&#xD;
        eligibility. Data of 3-month-follow-up data of included subjects were collected and analyzed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: To evaluate the effectiveness of standard therapy for acne vulgaris (AV) based on&#xD;
        the guidelines in Indonesia Design: An analytical retrospective observational study conducted&#xD;
        from April 2023 through July 2023 using medical records of new acne patients between 2017 to&#xD;
        2019 from Dr. Cipto Mangunkusumo National Central General Hospital. A total sample of&#xD;
        patients with AV who received standard therapy for acne vulgaris based on the guideline by&#xD;
        Dr.Cipto Mangunkusumo Hospital in 2017 and not associated with systemic diseases or drugs&#xD;
        were included. Patients were classified into mild, moderate, or severe acne using Lehmann&#xD;
        grading system. Primary outcomes were changes in the number of non-inflammatory,&#xD;
        inflammatory, and total lesions, and the proportion of acne severity after 3 months of&#xD;
        therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 18, 2023</start_date>
    <completion_date type="Actual">June 5, 2023</completion_date>
    <primary_completion_date type="Actual">May 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in non-inflammatory acne lesion count</measure>
      <time_frame>week-12</time_frame>
      <description>Change in the sum of the number of open and closed comedones</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in inflammatory acne lesion count</measure>
      <time_frame>week-12</time_frame>
      <description>Change in the sum of the number of papules, pustules, nodes, and cysts</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in total acne lesioncount</measure>
      <time_frame>week-12</time_frame>
      <description>Change in the sums of the number of non-inflammatory and inflammatory lesions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in acne severity</measure>
      <time_frame>week-12</time_frame>
      <description>Change in the acne severity based on Lehmann grading system (2002), which classified acne into mild, moderate, and severe</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">724</enrollment>
    <condition>Acne Vulgaris</condition>
    <arm_group>
      <arm_group_label>General</arm_group_label>
      <description>This research is an observational study. There was no control and experimental group.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          New patients with acne vulgaris coming to the dermatology outpatient clinic in dr.Cipto&#xD;
          Mangunkusumo hospital dated 2017 to 2019&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  New patients with acne vulgaris in the year 2017 to 2019&#xD;
  &#xD;
            -  Complete medical record data of 3-month follow-up, including data of: name, medical&#xD;
               record number, sex, age, job, level of education, visit date, number of&#xD;
               non-inflammatory, inflammatory, and total acne lesions, diagnosis of acne vulgaris&#xD;
               based on Lehmann grading system&#xD;
  &#xD;
            -  Acne treatment based on clinical practice guideline by dr.Cipto Mangunkusumo Hospital&#xD;
               2017&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Follow-up data less than 3 times in 3 months&#xD;
  &#xD;
            -  Incomplete medical record&#xD;
  &#xD;
            -  AV diagnosis without data on severity&#xD;
  &#xD;
            -  History of systemic diseases associated with acne such as polycystic ovarian syndrome&#xD;
               and Cushing syndrome&#xD;
  &#xD;
            -  History of allergy with one or more standard acne therapy based on the clinical&#xD;
               practice guideline&#xD;
  &#xD;
            -  Received acne therapy not aligned with clinical practice guideline by dr.Cipto&#xD;
               Mangunkusumo Hospital&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>dr.Cipto Mangunkusumo National Central General Hospital</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>Jakarta</state>
          <zip>10430</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <reference>
      <citation>Goh C, Cheng C, Agak G, et al. Acne vulgaris. In: Kang S, Amagai M, Bruckner AL, et al., eds. Fitzpatrick's Dermatology. 9th ed. McGraw-Hill; 2019:1391-1418.</citation>
    </reference>
    <reference>
      <citation>Wasitaatmadja SM, ed. Acne [Akne]. Badan Penerbit Fakultas Kedokteran Universitas Indonesia; 2018.</citation>
    </reference>
    <reference>
      <citation>Wasitaatmadja SM, Arimuko A, Norawati L, Bernadette I, Legiawati L, eds. Acne Management Guideline in Indonesia: Results Summary of Indonesian Acne Expert Meeting 2015 [ Pedoman Tata Laksana Akne Di Indonesia: Resume Hasil Indonesian Acne Expert Meeting 2015]. 2nd ed. Kelompok Studi Dermatologi Kosmetik Indonesia PERDOSKI; 2016.</citation>
    </reference>
    <reference>
      <citation>Tan AU, Schlosser BJ, Paller AS. A review of diagnosis and treatment of acne in adult female patients. Int J Womens Dermatol. 2017 Dec 23;4(2):56-71. doi: 10.1016/j.ijwd.2017.10.006. eCollection 2018 Jun.</citation>
      <PMID>29872679</PMID>
    </reference>
    <reference>
      <citation>Widaty S, Soebono H, Nilasari H, et al., eds. Akne. In: Clinical Practice Guidelines for Dermatology and Venereology Specialists in Indonesia [Panduan praktik klinis bagi dokter spesialis kulit dan kelamin di Indonesia]. Perhimpunan Dokter Spesialis Kulit dan Kelamin Indonesia (PERDOSKI); 2017:248-254.</citation>
    </reference>
    <reference>
      <citation>Department of Dermatology and Venereology dr. Cipto Mangunkusumo National Central General Hospital. Clinical Practice Guideline for Acne Vulgaris [Panduan Praktik Klinis Akne Vulgaris]. RSCM; 2017.</citation>
    </reference>
    <reference>
      <citation>Lehmann HP, Robinson KA, Andrews JS, Holloway V, Goodman SN. Acne therapy: a methodologic review. J Am Acad Dermatol. 2002 Aug;47(2):231-40. doi: 10.1067/mjd.2002.120912.</citation>
      <PMID>12140469</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>dr. Maria Clarissa Wiraputranto</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>acne vulgaris</keyword>
    <keyword>clinical practice guideline</keyword>
    <keyword>Indonesia</keyword>
    <keyword>effectiveness</keyword>
    <keyword>therapy</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>Undecided</sharing_ipd>
    </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/NCT05982613
  org study id: UIDV
  nct id: NCT05982613
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was to evaluate the effectiveness of standard therapy for acne vulgaris (AV) based
        on the clinical practice guidelines (CPG) in Indonesia. The main questions it aims to answer
        were:
  
          1. How is the clinical characteristics of patients with AV in dr.Cipto Mangunkusumo
             Hospital?
  
          2. How is the effectiveness of standard therapy for AV based on the CPG in Indonesia in
             reducing the number of non-inflammatory, inflammatory, and total lesions and degree of
             acne severity?
  
        The clinical pratice guideline (CPG) used for analysis was CPG by dr.Cipto Mangunkusumo
        Hospital 2017 in line with the date of patient visit. Data of 724 patients with AV in
        dr.Cipto Mangunkusumo Hospital as recorded in the medical records were assessed for
        eligibility. Data of 3-month-follow-up data of included subjects were collected and analyzed.
  Objective: To evaluate the effectiveness of standard therapy for acne vulgaris (AV) based on
        the guidelines in Indonesia Design: An analytical retrospective observational study conducted
        from April 2023 through July 2023 using medical records of new acne patients between 2017 to
        2019 from Dr. Cipto Mangunkusumo National Central General Hospital. A total sample of
        patients with AV who received standard therapy for acne vulgaris based on the guideline by
        Dr.Cipto Mangunkusumo Hospital in 2017 and not associated with systemic diseases or drugs
        were included. Patients were classified into mild, moderate, or severe acne using Lehmann
        grading system. Primary outcomes were changes in the number of non-inflammatory,
        inflammatory, and total lesions, and the proportion of acne severity after 3 months of
        therapy.
  observational model: Cohort
  time perspective: Retrospective
  measure: Change in non-inflammatory acne lesion count
  time frame: week-12
  description: Change in the sum of the number of open and closed comedones
  measure: Change in inflammatory acne lesion count
  time frame: week-12
  description: Change in the sum of the number of papules, pustules, nodes, and cysts
  measure: Change in total acne lesioncount
  time frame: week-12
  description: Change in the sums of the number of non-inflammatory and inflammatory lesions
  measure: Change in acne severity
  time frame: week-12
  description: Change in the acne severity based on Lehmann grading system (2002), which classified acne into mild, moderate, and severe
  arm group label: General
  description: This research is an observational study. There was no control and experimental group.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Indonesia
  citation: Goh C, Cheng C, Agak G, et al. Acne vulgaris. In: Kang S, Amagai M, Bruckner AL, et al., eds. Fitzpatrick's Dermatology. 9th ed. McGraw-Hill; 2019:1391-1418.
  citation: Wasitaatmadja SM, ed. Acne [Akne]. Badan Penerbit Fakultas Kedokteran Universitas Indonesia; 2018.
  citation: Wasitaatmadja SM, Arimuko A, Norawati L, Bernadette I, Legiawati L, eds. Acne Management Guideline in Indonesia: Results Summary of Indonesian Acne Expert Meeting 2015 [ Pedoman Tata Laksana Akne Di Indonesia: Resume Hasil Indonesian Acne Expert Meeting 2015]. 2nd ed. Kelompok Studi Dermatologi Kosmetik Indonesia PERDOSKI; 2016.
  citation: Tan AU, Schlosser BJ, Paller AS. A review of diagnosis and treatment of acne in adult female patients. Int J Womens Dermatol. 2017 Dec 23;4(2):56-71. doi: 10.1016/j.ijwd.2017.10.006. eCollection 2018 Jun.
  PMID: 29872679
  citation: Widaty S, Soebono H, Nilasari H, et al., eds. Akne. In: Clinical Practice Guidelines for Dermatology and Venereology Specialists in Indonesia [Panduan praktik klinis bagi dokter spesialis kulit dan kelamin di Indonesia]. Perhimpunan Dokter Spesialis Kulit dan Kelamin Indonesia (PERDOSKI); 2017:248-254.
  citation: Department of Dermatology and Venereology dr. Cipto Mangunkusumo National Central General Hospital. Clinical Practice Guideline for Acne Vulgaris [Panduan Praktik Klinis Akne Vulgaris]. RSCM; 2017.
  citation: Lehmann HP, Robinson KA, Andrews JS, Holloway V, Goodman SN. Acne therapy: a methodologic review. J Am Acad Dermatol. 2002 Aug;47(2):231-40. doi: 10.1067/mjd.2002.120912.
  PMID: 12140469
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: dr. Maria Clarissa Wiraputranto
  investigator title: Principal Investigator
  mesh term: Acne Vulgaris
  sharing ipd: Undecided