AcneNCT02152865
Clinical Trial of Lupeol for Mild-moderate Acne
A study testing Lupeol in people with Acne, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
For the chemical lupeol isolated from eggplant, we applied it to one side of face, and applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week, randomized controlled, split face fashion. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acne
- What is being tested?
- Lupeol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to May 2014
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over the age 15 who were clinically diagnosed with mild to moderate acne vulgaris
Who cannot join
- ; known pregnancy or lactation, any medical illness that might influence the results of the study, a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
For the chemical lupeol isolated from eggplant, we applied it to one side of face, and applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week, randomized controlled, split face fashion. Investigators evaluated safety and efficacy during baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.
- Conditions
- Acne
- Being tested
- Lupeol, Control vehicle
- Keywords
- medication
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LupeolDrug
Also called no brand name
Patients are supposed to apply lupeol cream to one side of their face two times per day for 8 weeks.
Control vehicleDrug
Also called No brand name
Patients are supposed to apply their control vehicle to the other side of their face for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lupeol | Active comparator | Patients are supposed to apply lupeol on one side of face two times per day for 8 weeks Receives: Drug: Lupeol |
| Control vehicle | Placebo comparator | Patients are supposed to apply vehicle control to another side of face two times per day for 8 weeks Receives: Drug: Control vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne lesion counts as a measure of efficacy
Both inflammatory \& non-inflammatory acne lesions of both of their facial sides
Measured: 8 weeks after beginning of applications
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Among total patients enrolled in this study, number of patients either experiencing objective adverse events or subjective uncomfortableness were counted
Measured: 8 weeks after beggning of applications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startDec 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae Hun Suh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152865
- Sponsor's protocol ID
- anti-acne product
- Status last verified
- May 2014
- First submitted
- 25 May 2014
- Last updated
- 2 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Lupeol for Mild-moderate Acne
- ClinicalTrials.gov ID
- NCT02152865
- Acronym / sponsor ID
- anti-acne product
- Conditions
- Acne
- Keywords
- medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Jun 2014 (estimated)
- 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.
For the chemical lupeol isolated from eggplant, we applied it to one side of face, and applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week, randomized controlled, split face fashion. Investigators evaluated safety and efficacy during baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lupeol | Active comparator | Drug: LupeolPatients are supposed to apply lupeol on one side of face two times per day for 8 weeks |
| Control vehicle | Placebo comparator | Drug: Control vehiclePatients are supposed to apply vehicle control to another side of face two times per day for 8 weeks |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age 15 who were clinically diagnosed with mild to moderate acne vulgaris
Key exclusion criteria (1 listed)
- ; known pregnancy or lactation, any medical illness that might influence the results of the study, a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.
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 |
|---|---|---|
| LupeolAlso: no brand namePatients are supposed to apply lupeol cream to one side of their face two times per day for 8 weeks. | Drug | Lupeol |
| Control vehicleAlso: No brand namePatients are supposed to apply their control vehicle to the other side of their face for 8 weeks | Drug | Control vehicle |
Primary outcome
Acne lesion counts as a measure of efficacy
Time frame: 8 weeks after beginning of applications
Both inflammatory \& non-inflammatory acne lesions of both of their facial sides
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 8 weeks after beggning of applications
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 2 Jun 2014.
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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 Lupeol in people with Acne, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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 2 Jun 2014. 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 South Korea. 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?
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?
Acne lesion counts as a measure of efficacy (time frame: 8 weeks after beginning of applications). 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 2 Jun 2014.