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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amorepacific Corporation

Criteria

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