Acne VulgarisNCT05982613
Effectiveness of Standard Therapy of Acne Vulgaris
An observational study of Acne Vulgaris, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acne Vulgaris
- How many people
- 724 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Apr 2023to 5 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: New patients with acne vulgaris coming to the dermatology outpatient clinic in dr.Cipto Mangunkusumo hospital dated 2017 to 2019
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
dr.Cipto Mangunkusumo National Central General Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Effectiveness of Standard Therapy of Acne Vulgaris Based on Clinical Practice Guidelines (CPG) in Indonesia
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, clinical practice guideline, Indonesia, effectiveness, therapy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General | This research is an observational study. There was no control and experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in non-inflammatory acne lesion count
Change in the sum of the number of open and closed comedones
Measured: week-12
Change in inflammatory acne lesion count
Change in the sum of the number of papules, pustules, nodes, and cysts
Measured: week-12
Change in total acne lesioncount
Change in the sums of the number of non-inflammatory and inflammatory lesions
Measured: 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
Measured: week-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start18 Apr 2023
- Primary completion31 May 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital, Ministry of Education, Culture, Research, and Technology of the Republic of Indonesia
- Responsible party
- Principal investigator, dr. Maria Clarissa Wiraputranto, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982613
- Sponsor's protocol ID
- UIDV
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
Wasitaatmadja SM, ed. Acne [Akne]. Badan Penerbit Fakultas Kedokteran Universitas Indonesia; 2018.
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.
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.
PubMed 29872679Widaty 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.
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.
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.
PubMed 12140469
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Standard Therapy of Acne Vulgaris Based on Clinical Practice Guidelines (CPG) in Indonesia
- ClinicalTrials.gov ID
- NCT05982613
- Acronym / sponsor ID
- UIDV
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, clinical practice guideline, Indonesia, effectiveness, therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital, Ministry of Education, Culture, Research, and Technology of the Republic of Indonesia
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General | – | –This research is an observational study. There was no control and experimental group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- New patients with acne vulgaris coming to the dermatology outpatient clinic in dr.Cipto Mangunkusumo hospital dated 2017 to 2019
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in non-inflammatory acne lesion count
Time frame: week-12
Change in the sum of the number of open and closed comedones
Change in inflammatory acne lesion count
Time frame: week-12
Change in the sum of the number of papules, pustules, nodes, and cysts
Change in total acne lesioncount
Time frame: week-12
Change in the sums of the number of non-inflammatory and inflammatory lesions
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- BackgroundGoh 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.
- BackgroundWasitaatmadja SM, ed. Acne [Akne]. Badan Penerbit Fakultas Kedokteran Universitas Indonesia; 2018.
- BackgroundWasitaatmadja 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: PubMed 29872679Tan 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.
- BackgroundWidaty 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.
- BackgroundDepartment 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: PubMed 12140469Lehmann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in non-inflammatory acne lesion count (time frame: week-12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982613, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.