RosaceaPhase 2NCT02583009
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea
A Phase 2 study testing PAC-14028 cream 0.1%, PAC-14028 cream 0.3% and PAC-14028 cream 1.0% in people with Rosacea, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028 cream 0.1%, 0.3% and 1.0% in patients with rosacea. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Rosacea
- What is being tested?
- PAC-14028 cream 0.1%, PAC-14028 cream 0.3% and PAC-14028 cream 1.0%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Aug 2016
- Phase
- Phase 2
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 19 - 70 years old
- Among the patients diagnosed with erythematotelangiectatic and papulopustular rosacea in accordance with the diagnostic criteria of the National Rosacea Society Expert Committee
- Subjects with rosacea scored 2 or more according to the Investigator Global Assessment (IGA) at screening
Who cannot join
- Those who can't be diagnosed or assessed for rosacea due to the presence of trauma, tattoo, scar, excessive hairs on the facial region
- Those who have received a facial laser treatment within 6 weeks
- Those who have been administered with oral retinoid or therapeutic vitamin A within 6 months
- Those who have received a hormonal treatment such as estrogen within 3 months
- Those who have been administered with systemic antibiotics or systemic steroid formulation within 4 weeks
- Those who have been administered with local retinoid, local steroid and local antibiotics and local medication for the treatment of rosacea on face within 4 weeks
- Those who have a history of blood disorder that can have a serious effect on the clinical study
- Women who are pregnant, lactating or who plan to be pregnant during the clinical study period or women of childbearing potential who do not use available contraceptive methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Anti Rosacea Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Rosacea Patients
This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028 cream 0.1%, 0.3% and 1.0% in patients with rosacea.
- Conditions
- Rosacea
- Being tested
- PAC-14028 cream 0.1%, PAC-14028 cream 0.3%, PAC-14028 cream 1.0%, PAC-14028 cream vehicle
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC-14028 cream 0.1%Drug
Topical application
PAC-14028 cream 0.3%Drug
Topical application
PAC-14028 cream 1.0%Drug
Topical application
PAC-14028 cream vehicleDrug
Topical application
| Study group | Role | What they receive |
|---|---|---|
| PAC-14028 cream 0.1% | Experimental | PAC-14028 cream 0.1%, Twice daily for 4 weeks Receives: Drug: PAC-14028 cream 0.1% |
| PAC-14028 cream 0.3% | Experimental | PAC-14028 cream 0.3%, Twice daily for 4 weeks Receives: Drug: PAC-14028 cream 0.3% |
| PAC-14028 cream 1.0% | Experimental | PAC-14028 cream 1.0%, Twice daily for 4 weeks Receives: Drug: PAC-14028 cream 1.0% |
| PAC-14028 cream vehicle | Placebo comparator | PAC-14028 cream vehicle, Twice daily for 4 weeks Receives: Drug: PAC-14028 cream vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Investigator Global Assessment (IGA)
Any intragroup and intergroup differences with respect to the IGA difference value on 28th day from the baseline.
Measured: Week 4 from the baseline
Secondary outcomes (5)
Improvement rate in Investigator Global Assessment (IGA)
Measured: Week 4 from the baseline
Change in the erythema severity score
Measured: Week 4 from the baseline
Rate of change in inflammatory lesion counts
Measured: Week 4 from the baseline
Change in erythema index
Measured: Week 4 from the baseline
Change in the telangiectasia severity score
Measured: Week 4 from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2014
- Primary completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miyoung Park, PhD, Study director, Amorepacific R&D Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583009
- Sponsor's protocol ID
- AP-TRPV1_PII-03
- Status last verified
- Sep 2016
- First submitted
- 30 Sep 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Anti Rosacea Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Rosacea Patients
- ClinicalTrials.gov ID
- NCT02583009
- Acronym / sponsor ID
- AP-TRPV1_PII-03
- Conditions
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (actual)
- First posted
- 21 Oct 2015 (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.
This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028 cream 0.1%, 0.3% and 1.0% in patients with rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PAC-14028 cream 0.1% | Experimental | Drug: PAC-14028 cream 0.1%PAC-14028 cream 0.1%, Twice daily for 4 weeks |
| PAC-14028 cream 0.3% | Experimental | Drug: PAC-14028 cream 0.3%PAC-14028 cream 0.3%, Twice daily for 4 weeks |
| PAC-14028 cream 1.0% | Experimental | Drug: PAC-14028 cream 1.0%PAC-14028 cream 1.0%, Twice daily for 4 weeks |
| PAC-14028 cream vehicle | Placebo comparator | Drug: PAC-14028 cream vehiclePAC-14028 cream vehicle, Twice daily for 4 weeks |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients aged 19 - 70 years old
- Among the patients diagnosed with erythematotelangiectatic and papulopustular rosacea in accordance with the diagnostic criteria of the National Rosacea Society Expert Committee
- Subjects with rosacea scored 2 or more according to the Investigator Global Assessment (IGA) at screening
Key exclusion criteria (8 listed)
- Those who can't be diagnosed or assessed for rosacea due to the presence of trauma, tattoo, scar, excessive hairs on the facial region
- Those who have received a facial laser treatment within 6 weeks
- Those who have been administered with oral retinoid or therapeutic vitamin A within 6 months
- Those who have received a hormonal treatment such as estrogen within 3 months
- Those who have been administered with systemic antibiotics or systemic steroid formulation within 4 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 |
|---|---|---|
| PAC-14028 cream 0.1%Topical application | Drug | PAC-14028 cream 0.1% |
| PAC-14028 cream 0.3%Topical application | Drug | PAC-14028 cream 0.3% |
| PAC-14028 cream 1.0%Topical application | Drug | PAC-14028 cream 1.0% |
| PAC-14028 cream vehicleTopical application | Drug | PAC-14028 cream vehicle |
Primary outcome
Change in Investigator Global Assessment (IGA)
Time frame: Week 4 from the baseline
Any intragroup and intergroup differences with respect to the IGA difference value on 28th day from the baseline.
5 secondary outcomes
Improvement rate in Investigator Global Assessment (IGA)
Time frame: Week 4 from the baseline
Change in the erythema severity score
Time frame: Week 4 from the baseline
Rate of change in inflammatory lesion counts
Time frame: Week 4 from the baseline
Change in erythema index
Time frame: Week 4 from the baseline
Change in the telangiectasia severity score
Time frame: Week 4 from the baseline
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 20 Sep 2016.
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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.
Miyoung Park, PhD study director
Amorepacific R&D Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PAC-14028 cream 0.1%, PAC-14028 cream 0.3% and PAC-14028 cream 1.0% in people with Rosacea, run by Amorepacific Corporation 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 3 inclusion and 8 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 20 Sep 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Investigator Global Assessment (IGA) (time frame: Week 4 from the baseline). 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 20 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.