Clinical trial NCT05982613: Effectiveness of Standard Therapy of Acne Vulgaris
Official title: Effectiveness of Standard Therapy of Acne Vulgaris Based on Clinical Practice Guidelines (CPG) in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Keywords: acne vulgaris
clinical practice guideline
Indonesia
effectiveness
therapy
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
name: Ministry of Education, Culture, Research, and Technology of the Republic of Indonesia
First posted: 2023-08-08
Enrollment: 724
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New patients with acne vulgaris coming to the dermatology outpatient clinic in dr.Cipto Mangunkusumo hospital dated 2017 to 2019

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in non-inflammatory acne lesion count
timeFrame: week-12
measure: Change in inflammatory acne lesion count
timeFrame: week-12
measure: Change in total acne lesioncount
timeFrame: week-12
measure: Change in acne severity
timeFrame: week-12
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: dr.Cipto Mangunkusumo National Central General Hospital
state: Jakarta
Study officials:
References:
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.
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.