Effectiveness of Standard Therapy of Acne Vulgaris

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT05982613
Collaborator
Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia (Other), Ministry of Education, Culture, Research, and Technology of the Republic of Indonesia (Other)
724
1
1.6
459.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    724 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Effectiveness of Standard Therapy of Acne Vulgaris Based on Clinical Practice Guidelines (CPG) in Indonesia
    Actual Study Start Date :
    Apr 18, 2023
    Actual Primary Completion Date :
    May 31, 2023
    Actual Study Completion Date :
    Jun 5, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    General

    This research is an observational study. There was no control and experimental group.

    Outcome Measures

    Primary Outcome Measures

    1. Change in non-inflammatory acne lesion count [week-12]

      Change in the sum of the number of open and closed comedones

    2. Change in inflammatory acne lesion count [week-12]

      Change in the sum of the number of papules, pustules, nodes, and cysts

    3. Change in total acne lesioncount [week-12]

      Change in the sums of the number of non-inflammatory and inflammatory lesions

    4. Change in acne severity [week-12]

      Change in the acne severity based on Lehmann grading system (2002), which classified acne into mild, moderate, and severe

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • New patients with acne vulgaris in the year 2017 to 2019

    • Complete medical record data of 3-month follow-up, including data of: name, medical record number, sex, age, job, level of education, visit date, number of non-inflammatory, inflammatory, and total acne lesions, diagnosis of acne vulgaris based on Lehmann grading system

    • Acne treatment based on clinical practice guideline by dr.Cipto Mangunkusumo Hospital 2017

    Exclusion Criteria:
    • Follow-up data less than 3 times in 3 months

    • Incomplete medical record

    • AV diagnosis without data on severity

    • History of systemic diseases associated with acne such as polycystic ovarian syndrome and Cushing syndrome

    • History of allergy with one or more standard acne therapy based on the clinical practice guideline

    • Received acne therapy not aligned with clinical practice guideline by dr.Cipto Mangunkusumo Hospital

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 dr.Cipto Mangunkusumo National Central General Hospital Jakarta Pusat Jakarta Indonesia 10430

    Sponsors and Collaborators

    • Indonesia University
    • Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
    • Ministry of Education, Culture, Research, and Technology of the Republic of Indonesia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    dr. Maria Clarissa Wiraputranto, Principal Investigator, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT05982613
    Other Study ID Numbers:
    • UIDV
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by dr. Maria Clarissa Wiraputranto, Principal Investigator, Indonesia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2023