Effectiveness of Standard Therapy of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05982613
• Other study ID #: UIDV
• Status: Completed
• Start date: April 18, 2023
• Est. completion date: June 5, 2023

Study information

• Verified date: August 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 724
• Est. completion date: June 5, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Locations

Country	Name	City	State
Indonesia	dr.Cipto Mangunkusumo National Central General Hospital	Jakarta Pusat	Jakarta

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Indonesia, 

References & Publications (7)

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.

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.

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. — View 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. — View 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.

Wasitaatmadja SM, ed. Acne [Akne]. Badan Penerbit Fakultas Kedokteran Universitas Indonesia; 2018.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in non-inflammatory acne lesion count	Change in the sum of the number of open and closed comedones	week-12
Primary	Change in inflammatory acne lesion count	Change in the sum of the number of papules, pustules, nodes, and cysts	week-12
Primary	Change in total acne lesioncount	Change in the sums of the number of non-inflammatory and inflammatory lesions	week-12
Primary	Change in acne severity	Change in the acne severity based on Lehmann grading system (2002), which classified acne into mild, moderate, and severe	week-12