A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea
NCT ID: NCT02583009
Last Updated: 2016-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
216 participants
INTERVENTIONAL
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PAC-14028 cream 0.1%
PAC-14028 cream 0.1%, Twice daily for 4 weeks
PAC-14028 cream 0.1%
Topical application
PAC-14028 cream 0.3%
PAC-14028 cream 0.3%, Twice daily for 4 weeks
PAC-14028 cream 0.3%
Topical application
PAC-14028 cream 1.0%
PAC-14028 cream 1.0%, Twice daily for 4 weeks
PAC-14028 cream 1.0%
Topical application
PAC-14028 cream vehicle
PAC-14028 cream vehicle, Twice daily for 4 weeks
PAC-14028 cream vehicle
Topical application
Interventions
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PAC-14028 cream 0.1%
Topical application
PAC-14028 cream 0.3%
Topical application
PAC-14028 cream 1.0%
Topical application
PAC-14028 cream vehicle
Topical application
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
19 Years
70 Years
ALL
No
Sponsors
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Amorepacific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Miyoung Park, PhD
Role: STUDY_DIRECTOR
Amorepacific R&D Center
Locations
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Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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AP-TRPV1_PII-03
Identifier Type: -
Identifier Source: org_study_id
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