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

NCT ID: NCT02052999

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-08-31

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

Conditions

Erythematotelangiectatic Rosacea; Papulopustular Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PAC-14028 cream 1%

PAC-14028 cream 1%, twice daily for 8 weeks

Group Type: EXPERIMENTAL

PAC-14028 cream 1%

Intervention Type: DRUG

Participants received topical PAC-14028 cream 1% twice daily for 8 weeks

Rozex gel 0.75%

Rozex gel 0.75%, twice daily for 8 weeks

Group Type: ACTIVE_COMPARATOR

Rozex gel 0.75%

Intervention Type: DRUG

Participants received topical Rozex gel 0.75% twice daily for 8 weeks

Vehicle

Vehicle, twice daily for 8 weeks

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: OTHER

Participants received topical Vehicle twice daily for 8 weeks

Interventions

PAC-14028 cream 1%

Participants received topical PAC-14028 cream 1% twice daily for 8 weeks

Intervention Type: DRUG

Vehicle

Participants received topical Vehicle twice daily for 8 weeks

Intervention Type: OTHER

Rozex gel 0.75%

Participants received topical Rozex gel 0.75% twice daily for 8 weeks

Intervention Type: DRUG

Other Intervention Names

PAC-14028; Vehicle of PAC-14028 Cream

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amorepacific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BeomJoon Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Chungang University Hospital

Locations

Chung-Ang University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

TRPV1-ROSACEA_IIT

Identifier Type: -

Identifier Source: org_study_id