Facial AcneNCT02192632
Dermatologists' Educational Demonstration for Epiduo Application
A study testing Epiduo once daily with detailed instruction for how to apply it, Epiduo- once daily, simple instruction for application and BPO once daily in people with Facial Acne and Local Adverse Effects, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and tolerability of this combination gel compared with BPO monotherapy in Korean patients, and test clinical practicability of dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable irritations. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Facial Acne, Local Adverse Effects
- What is being tested?
- Epiduo once daily with detailed instruction for how to apply it, Epiduo- once daily, simple instruction for application and BPO once daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Feb 2015
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- mild to moderate acne were evaluated by Leeds revised acne grade from 2 to 6
- age: 18-40
Who cannot join
- pregnancy
- mental illness
- intake of oral isotretinoin within 6 months
- application of the other oral or topical acne medications
- chemical peeling or light based treatments within 6 weeks.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dermatology, Seoul National University
Seoul, Joungro, 110-744
About this study
The purpose of this study is to evaluate the efficacy and tolerability of this combination gel compared with BPO monotherapy in Korean patients, and test clinical practicability of dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable irritations.
- Conditions
- Facial Acne, Local Adverse Effects
- Being tested
- Epiduo once daily with detailed instruction for how to apply it, Epiduo- once daily, simple instruction for application, BPO once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiduo once daily with detailed instruction for how to apply itDrug
Epiduo- once daily, simple instruction for applicationDrug
BPO once dailyDrug
| Study group | Role | What they receive |
|---|---|---|
| Epiduo- dermatologist's detailed instruction | Experimental | After randomly assigned to side of epiduo application, half of total patients were also re-assigned into detailed instruction for application of epiduo from dermatologist Receives: Drug: Epiduo once daily with detailed instruction for how to apply it |
| Epiduo- drug insert only gruop | Experimental | After randomly assigned to side of epiduo application, half of total patients were also re-assigned into drug insert only group Receives: Drug: Epiduo- once daily, simple instruction for application |
| BPO group | Placebo comparator | After randomly assigned to side of BPO application, patients apply BPO during 12 week Receives: Drug: BPO once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentile reduction of non-inflammatory & inflammatory acne lesions
Measurement of decreases in both non-inflammatory \& inflammatory acne lesions
Measured: 12 weeks
Secondary outcomes (1)
Total number of local irriation effect counts (erythema, scaling, dryness, itching)
Calcuation of total number of local irriation effect counts (erythema, scaling, dryness, itching)
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 85 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
- NCT02192632
- Sponsor's protocol ID
- ADP-BPO
- Other IDs
- 1402-051-555
- Status last verified
- Mar 2015
- First submitted
- 14 Jul 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatologists' Educational Demonstration for Epiduo Application
- ClinicalTrials.gov ID
- NCT02192632
- Acronym / sponsor ID
- ADP-BPO
- Conditions
- Facial Acne, Local Adverse Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 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.
The purpose of this study is to evaluate the efficacy and tolerability of this combination gel compared with BPO monotherapy in Korean patients, and test clinical practicability of dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable irritations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epiduo- dermatologist's detailed instruction | Experimental | Drug: Epiduo once daily with detailed instruction for how to apply itAfter randomly assigned to side of epiduo application, half of total patients were also re-assigned into detailed instruction for application of epiduo from dermatologist |
| Epiduo- drug insert only gruop | Experimental | Drug: Epiduo- once daily, simple instruction for applicationAfter randomly assigned to side of epiduo application, half of total patients were also re-assigned into drug insert only group |
| BPO group | Placebo comparator | Drug: BPO once dailyAfter randomly assigned to side of BPO application, patients apply BPO during 12 week |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- mild to moderate acne were evaluated by Leeds revised acne grade from 2 to 6
- age: 18-40
Key exclusion criteria (5 listed)
- pregnancy
- mental illness
- intake of oral isotretinoin within 6 months
- application of the other oral or topical acne medications
- chemical peeling or light based treatments within 6 weeks.
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 |
|---|---|---|
| Epiduo once daily with detailed instruction for how to apply it | Drug | Epiduo- dermatologist's detailed instruction |
| Epiduo- once daily, simple instruction for application | Drug | Epiduo- drug insert only gruop |
| BPO once daily | Drug | BPO group |
Primary outcome
Percentile reduction of non-inflammatory & inflammatory acne lesions
Time frame: 12 weeks
Measurement of decreases in both non-inflammatory \& inflammatory acne lesions
1 secondary outcome
Total number of local irriation effect counts (erythema, scaling, dryness, itching)
Time frame: 12 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 17 Mar 2015.
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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 Epiduo once daily with detailed instruction for how to apply it, Epiduo- once daily, simple instruction for application and BPO once daily in people with Facial Acne and Local Adverse Effects, 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 2 inclusion and 5 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 17 Mar 2015. 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?
Percentile reduction of non-inflammatory & inflammatory acne lesions (time frame: 12 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 17 Mar 2015.