Effectiveness of Standard Therapy of Acne Vulgaris Based on Clinical Practice Guidelines (CPG) in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 724
- 试验地点
- 1
- 主要终点
- Change in non-inflammatory acne lesion count
研究概览
简要总结
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:
- How is the clinical characteristics of patients with AV in dr.Cipto Mangunkusumo Hospital?
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in non-inflammatory acne lesion count
时间窗: week-12
Change in the sum of the number of open and closed comedones
Change in total acne lesioncount
时间窗: week-12
Change in the sums of the number of non-inflammatory and inflammatory lesions
Change in inflammatory acne lesion count
时间窗: week-12
Change in the sum of the number of papules, pustules, nodes, and cysts
Change in acne severity
时间窗: week-12
Change in the acne severity based on Lehmann grading system (2002), which classified acne into mild, moderate, and severe
次要结局
未报告次要终点
研究者
dr. Maria Clarissa Wiraputranto
Principal Investigator
Indonesia University