Effectiveness of Standard Therapy of Acne Vulgaris

NCT05982613 | Completed

• 1 other identifier: UIDV
• Study Type: observational
• Target: 724
• Locations: 1 country
• Sites: 1

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. 1.How is the clinical characteristics of patients with AV in dr.Cipto Mangunkusumo Hospital?
2. 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?

Conditions

Acne Vulgaris

Keywords

acne vulgaris; clinical practice guideline; Indonesia; effectiveness; therapy

Outcome Measures

Primary Outcomes (4)

• Change in non-inflammatory acne lesion count

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

  week-12

• Change in inflammatory acne lesion count

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

  week-12

• Change in total acne lesioncount

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

  week-12

• 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

Study Arms (1)

General

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

dr.Cipto Mangunkusumo National Central General Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (7)

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29872679 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12140469 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 8, 2023
• Study Start: April 18, 2023
• Primary Completion: May 31, 2023
• Study Completion: June 5, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

ID (1)