Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients
Phase 2
Completed
- Conditions
- Erythematotelangiectatic RosaceaPapulopustular Rosacea
- Interventions
- Registration Number
- NCT02052999
- Lead Sponsor
- Amorepacific Corporation
- Brief Summary
The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
-
Male and female patients at the age of 20 to 65 years old
-
Clinical diagnosis of erythematotelangiectatic or papulopustular rosacea according to National Rosacea Committee Expert Society with
- Erythema severity ≥ 1
- Telangiectasia severity ≥ 1
- At least 3 papules or pustules in facial region
-
IGA score ≥ 2
-
Voluntarily signed written informed consent forms for study participation
Exclusion Criteria
- Patients who are unable to be diagnosed or evaluated for rosacea due to tattoo or scar in the facial area
- Patients who are unable to be diagnosed or evaluated for rosacea due to excess hair(e.g., mustache, beard, whiskers etc.) in the facial area
- Patients who are sensitive to the drug or vehicle
- Previous administration of oral retinoid or vitamin A(≥10,000 units/day) within 6 months prior to visit 1
- Previous use of estrogen or oral contraceptives within 3 months prior to visit 1
- Previous use of topical retinoids or oral antibiotics (e.g., tetracycline, tetracycline derivatives, erythromycin, erythromycin derivatives, sulfamethoxazole, trimethoprim) or oral steroid for the treatment of facial rosacea within 1 month prior to visit 1
- Previous use of topical steroid or topical antibiotics, topical treatment for rosacea(e.g., metronidazole, azelaic acid) within 2 weeks prior to visit 1
- Presently undergoing anti-coagulant therapies
- History of hematologic disease
- Ocular-only, Phymatous rosacea, or papulopustular rosacea patients who require systemic antibiotics
- History of laser treatment for rosacea within 6 weeks prior to visit 1
- Alcoholic or drug abuse patients
- Patients who are treated with prohibited concomitant drugs or considered to inevitably require treatment with prohibited concomitant drugs during the study period
- Renal function impairment with creatinine level higher than twice of maximum normal range
- Hepatic function impairment with AST/ALT higher than twice of maximum normal range
- Pregnant and lactating woman, woman with child-birth potential(should have negative pregnancy test at the baseline visit of the study)
- Participation in another clinical study within 1 month prior to screening
- Patients considered ineligible for study participation by the principal investigator or sub-investigator for other reasons; rosacea due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PAC-14028 cream 1% PAC-14028 cream 1% PAC-14028 cream 1%, twice daily for 8 weeks Vehicle Vehicle Vehicle, twice daily for 8 weeks Rozex gel 0.75% Rozex gel 0.75% Rozex gel 0.75%, twice daily for 8 weeks
- Primary Outcome Measures
Name Time Method Change in Investigator Global Assessment (IGA) Baseline through Study Week 8
- Secondary Outcome Measures
Name Time Method Erythema severity Baseline through Study Week 8 Telangiectasia severity Baseline through Study Week 8 Inflammatory lesion counts Baseline through Study Week 8
Trial Locations
- Locations (1)
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital🇰🇷Seoul, Korea, Republic of