Acne VulgarisNCT06181838
Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction
A study testing Lesion extraction and Tretinoin in people with Acne Vulgaris and Quality of Life, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Quality of Life
- What is being tested?
- Lesion extraction and Tretinoin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Aug 2023to 3 Jan 2024
- Phase
- Interventional
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically diagnosed as moderate acne vulgaris
- Able to read and speak in Indonesia
- Indonesian Citizen
- Sign the consent form
Who cannot join
- Pregnant of breastfeeding women
- Acne vulgaris lesion located only outside of face
- Experiencing COVID-19 symptoms
- Using retinoid acid containing cream or benzoil peroxide in the last 2 weeks
- Consume any oral antibiotics in the last 1 month
- Injected with intralesional steroid or having acne lesions extracted in the last 2 weeks
- Having laser or chemical peeling in the last 1 month
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Single-Blinded Randomized Controlled Trial: Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction
This study will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions.
Read the detailed description
The group allocation will be randomized. Outcome of the study is the quality of life score based on Acne-QoL-INA questionnaire. The study duration is 8 weeks, consists of baseline visit and 2 follow ups at 4th and 8th weeks.
- Conditions
- Acne Vulgaris, Quality of Life
- Being tested
- Lesion extraction, Tretinoin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lesion extractionProcedure or surgery
Also called Tretinoin, Benzoil peroxide
Tretinoin and benzoil peroxide used concurent in both groups as standard therapy
TretinoinDrug
Also called Benzoil peroxide
Tretinoin and benzoil peroxide used concurent in both groups as standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Standard therapy and lesion extraction Receives: Procedure: Lesion extraction |
| Control | Placebo comparator | Standard therapy without lesion extraction Receives: Drug: Tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Score
Measured using Acne-QoL-INA questionnaire
Measured: Every 4 weeks, measured until 8 weeks
Secondary outcomes (1)
Acne Grading
Lehmann classification of Acne Grading
Measured: Every 4 weeks, measured until 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start28 Aug 2023
- Primary completion24 Nov 2023
- Study completion3 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christa Desire Gracia, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181838
- Sponsor's protocol ID
- 23-05-0571
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Blinded Randomized Controlled Trial: Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction
- ClinicalTrials.gov ID
- NCT06181838
- Acronym / sponsor ID
- 23-05-0571
- Conditions
- Acne Vulgaris, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 3 Jan 2024 (estimated)
- First posted
- 26 Dec 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 will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions.
Detailed description
The group allocation will be randomized. Outcome of the study is the quality of life score based on Acne-QoL-INA questionnaire. The study duration is 8 weeks, consists of baseline visit and 2 follow ups at 4th and 8th weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Procedure: Lesion extractionStandard therapy and lesion extraction |
| Control | Placebo comparator | Drug: TretinoinStandard therapy without lesion extraction |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinically diagnosed as moderate acne vulgaris
- Able to read and speak in Indonesia
- Indonesian Citizen
- Sign the consent form
Key exclusion criteria (7 listed)
- Pregnant of breastfeeding women
- Acne vulgaris lesion located only outside of face
- Experiencing COVID-19 symptoms
- Using retinoid acid containing cream or benzoil peroxide in the last 2 weeks
- Consume any oral antibiotics in the last 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lesion extractionAlso: Tretinoin, Benzoil peroxideTretinoin and benzoil peroxide used concurent in both groups as standard therapy | Procedure or surgery | Intervention |
| TretinoinAlso: Benzoil peroxideTretinoin and benzoil peroxide used concurent in both groups as standard therapy | Drug | Control |
Primary outcome
Quality of Life Score
Time frame: Every 4 weeks, measured until 8 weeks
Measured using Acne-QoL-INA questionnaire
1 secondary outcome
Acne Grading
Time frame: Every 4 weeks, measured until 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
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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?
A study testing Lesion extraction and Tretinoin in people with Acne Vulgaris and Quality of Life, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Dec 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Quality of Life Score (time frame: Every 4 weeks, measured until 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2023.