Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients

Study Overview
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Brief Summary
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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

Official Title
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An Open Label Pilot Study to Evaluate the Efficacy of PAC-14028 in the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea

Conditions
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Erythematotelangiectatic Rosacea, Papulopustular Rosacea

Intervention / Treatment
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* Drug: PAC-14028 cream 1%
* Other: Vehicle
* Drug: Rozex gel 0.75%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAC-14028 cream 1%<br>PAC-14028 cream 1%, twice daily for 8 weeks | Drug: PAC-14028 cream 1%<br>* Participants received topical PAC-14028 cream 1% twice daily for 8 weeks<br>* Other names: PAC-14028;|
| Active Comparator: Rozex gel 0.75%<br>Rozex gel 0.75%, twice daily for 8 weeks | Drug: Rozex gel 0.75%<br>* Participants received topical Rozex gel 0.75% twice daily for 8 weeks<br>|
| Placebo Comparator: Vehicle<br>Vehicle, twice daily for 8 weeks | Other: Vehicle<br>* Participants received topical Vehicle twice daily for 8 weeks<br>* Other names: Vehicle of PAC-14028 Cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Investigator Global Assessment (IGA) |  | Baseline through Study Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema severity |  | Baseline through Study Week 8 | 
| Telangiectasia severity |  | Baseline through Study Week 8 | 
| Inflammatory lesion counts |  | Baseline through Study Week 8 |