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NCT Number: NCT05982613

Effectiveness of Standard Therapy of Acne Vulgaris

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

dr.Cipto Mangunkusumo National Central General Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in non-inflammatory acne lesion count

    Time frame: week-12

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

  2. Change in inflammatory acne lesion count

    Time frame: week-12

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

  3. Change in total acne lesioncount

    Time frame: week-12

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

  4. Change in acne severity

    Time frame: week-12

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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Dr Cipto Mangunkusumo General Hospital
  • Ministry of Education, Culture, Research, and Technology of the Republic of Indonesia

Registry information

Official study title

Effectiveness of Standard Therapy of Acne Vulgaris Based on Clinical Practice Guidelines (CPG) in Indonesia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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