AcneNCT02205892
Clinical Study for Topical Lupeol in Acne
A study testing Lupeol in people with Acne, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Double-blind, randomized,4-week small-scale clinical trial for lupeol in the treatment of inflammatory and non-inflammatory acne lesions in 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
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Sep 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 years of age or older who were clinically diagnosed with mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7)
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 Department of Dermatology
Seoul, 110-744
About this study
Official title: Clinical Study for the Effectiveness and Safety of Topical Lupeol in Mild to Moderate Acne
Double-blind, randomized,4-week small-scale clinical trial for lupeol in the treatment of inflammatory and non-inflammatory acne lesions in split face fashion
Read the detailed description
To investigate the clinical efficacy and tolerability of lupeol for the treatment of facial acne, we conducted a small-scale, randomized, double-blinded, split-face clinical trial over the course of 4 weeks. Fifteen of 16 enrolled patients completed the study, in which affected areas on half each patient's face were treated with 2% lupeol twice daily while the other side of the face was treated with a vehicle control. Clinical visits were scheduled at baseline and at 2 and 4 weeks. The primary outcome of the study was the percent change in inflammatory lesions (papules, pustules, and nodules) at 4 weeks. The secondary outcomes were the percent change in non-inflammatory lesions (open and closed comedones) and the change in the Leeds revised acne grading system score at 4 weeks. Adverse events (AEs) were defined as all unintended and harmful signs or symptoms; these were assessed by both patients' self-reporting and physicians' skin examination at each visit. Results were analyzed using intent to treat (ITT) groups. The per-protocol (PP) population consisted of the 15 patients who did not have any major protocol deviations. Last observation carried forward (LOCF) analysis was used to evaluate the primary and secondary outcomes.
Randomization and blindness process
At the time of initial presentation, an evaluation of acne severity was performed using both individual counts of inflammatory and non-inflammatory acne lesions and an assessment of the Leeds revised acne grading system score. Then, patients were randomly assigned to either left- or right-sided lupeol application, with the other side of the face assigned to vehicle-control application. A simple random allocation sequence was created using computer-based random number generators with a block size of 4. All dermatologists participating in outcome assessments, a physician assistant managing trial enrollment and administration, medical statisticians analyzing the data, and patients were blinded to the assignments. Randomization codes were strictly secured in a safe in the administration office of the clinical research center until data entry was complete. The integrity of the blinding was ensured by packaging the study- and control products in identical tubes and by requiring a third party (other than the investigator/evaluator) to dispense the medication. In addition, both topical agents were identical in color and odor.
- Conditions
- Acne
- Being tested
- Lupeol, Placebo vehicle
- Keywords
- natural product, clinical trial
- 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
Patients are supposed to apply 2% lupeol cream to one side of their face two times per day for 4 weeks. Application side is randomly determined.
Placebo vehicleDrug
Patients are supposed to apply their control vehicle cream two times per day to the other side of their face for 4 weeks. Application side is randomly determined.
| Study group | Role | What they receive |
|---|---|---|
| Lupeol | Active comparator | Not described Receives: Drug: Lupeol |
| Vehicle | Placebo comparator | Not described Receives: Drug: Placebo vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of inflammatory acne lesion counts
Measured: 4 week
Secondary outcomes (1)
Percent change of non-inflammatory acne lesion counts
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014
- Study completionSep 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 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
- Investigators
- Dae Hun Suh, MD, Principal investigator, Seoul National University Department of DermatologyHyuck Hoon Kwon, MD, Study director, Seoul National University Department of DermatologySun Yong Park, Study director, Seoul National University Department of DermatologySeounguk Min, Study director, Seoul National University Department of DermatologyJae Yoon Jung, Study director, Seoul National University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205892
- Sponsor's protocol ID
- SNUH-lupeol
- Status last verified
- Sep 2014
- First submitted
- 30 Jul 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for the Effectiveness and Safety of Topical Lupeol in Mild to Moderate Acne
- ClinicalTrials.gov ID
- NCT02205892
- Acronym / sponsor ID
- SNUH-lupeol
- Conditions
- Acne
- Keywords
- natural product, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Jul 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.
Double-blind, randomized,4-week small-scale clinical trial for lupeol in the treatment of inflammatory and non-inflammatory acne lesions in split face fashion
Detailed description
To investigate the clinical efficacy and tolerability of lupeol for the treatment of facial acne, we conducted a small-scale, randomized, double-blinded, split-face clinical trial over the course of 4 weeks. Fifteen of 16 enrolled patients completed the study, in which affected areas on half each patient's face were treated with 2% lupeol twice daily while the other side of the face was treated with a vehicle control. Clinical visits were scheduled at baseline and at 2 and 4 weeks. The primary outcome of the study was the percent change in inflammatory lesions (papules, pustules, and nodules) at 4 weeks. The secondary outcomes were the percent change in non-inflammatory lesions (open and closed comedones) and the change in the Leeds revised acne grading system score at 4 weeks. Adverse events (AEs) were defined as all unintended and harmful signs or symptoms; these were assessed by both patients' self-reporting and physicians' skin examination at each visit. Results were analyzed using intent to treat (ITT) groups. The per-protocol (PP) population consisted of the 15 patients who did not have any major protocol deviations. Last observation carried forward (LOCF) analysis was used to evaluate the primary and secondary outcomes.
Randomization and blindness process
At the time of initial presentation, an evaluation of acne severity was performed using both individual counts of inflammatory and non-inflammatory acne lesions and an assessment of the Leeds revised acne grading system score. Then, patients were randomly assigned to either left- or right-sided lupeol application, with the other side of the face assigned to vehicle-control application. A simple random allocation sequence was created using computer-based random number generators with a block size of 4. All dermatologists participating in outcome assessments, a physician assistant managing trial enrollment and administration, medical statisticians analyzing the data, and patients were blinded to the assignments. Randomization codes were strictly secured in a safe in the administration office of the clinical research center until data entry was complete. The integrity of the blinding was ensured by packaging the study- and control products in identical tubes and by requiring a third party (other than the investigator/evaluator) to dispense the medication. In addition, both topical agents were identical in color and odor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lupeol | Active comparator | Drug: Lupeol |
| Vehicle | Placebo comparator | Drug: Placebo vehicle |
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 years of age or older who were clinically diagnosed with mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7)
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 |
|---|---|---|
| LupeolPatients are supposed to apply 2% lupeol cream to one side of their face two times per day for 4 weeks. Application side is randomly determined. | Drug | Lupeol |
| Placebo vehiclePatients are supposed to apply their control vehicle cream two times per day to the other side of their face for 4 weeks. Application side is randomly determined. | Drug | Vehicle |
Primary outcome
Percent change of inflammatory acne lesion counts
Time frame: 4 week
1 secondary outcome
Percent change of non-inflammatory acne lesion counts
Time frame: 4 week
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 29 Sep 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.
Dae Hun Suh, MD principal investigator
Seoul National University Department of Dermatology
Hyuck Hoon Kwon, MD study director
Seoul National University Department of Dermatology
Sun Yong Park study director
Seoul National University Department of Dermatology
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 29 Sep 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?
Percent change of inflammatory acne lesion counts (time frame: 4 week). 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 Sep 2014.