A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus

NCT ID: NCT02565134

Last Updated: 2016-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-07-31

Brief Summary

The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.

Conditions

Skin Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PAC-14028 cream 0.1%

PAC-14028 cream 0.1%, Twice daily for 4 weeks

Group Type: EXPERIMENTAL

PAC-14028 cream 0.1%

Intervention Type: DRUG

Topical application

PAC-14028 cream 0.3%

PAC-14028 cream 0.3%, Twice daily for 4 weeks

Group Type: EXPERIMENTAL

PAC-14028 cream 0.3%

Intervention Type: DRUG

Topical application

PAC-14028 cream 1.0%

PAC-14028 cream 1.0%, Twice daily for 4 weeks

Group Type: EXPERIMENTAL

PAC-14028 cream 1.0%

Intervention Type: DRUG

Topical application

PAC-14028 cream vehicle

PAC-14028 cream vehicle, Twice daily for 4 weeks

Group Type: PLACEBO_COMPARATOR

PAC-14028 cream vehicle

Intervention Type: DRUG

Topical application

Interventions

PAC-14028 cream 0.1%

Topical application

Intervention Type: DRUG

PAC-14028 cream 0.3%

Topical application

Intervention Type: DRUG

PAC-14028 cream 1.0%

Topical application

Intervention Type: DRUG

PAC-14028 cream vehicle

Topical application

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patients aged 19 - 70 years
• Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg)
• Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more
• Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more

Exclusion Criteria

• Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease
• Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases
• Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound
• Patients with the symptom of systemic infection at the time of the participation in the clinical study
• Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks
• Patients with a history of taking oral steroid agent within 4 weeks
• Patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks
• Pregnant or breast-feeding women
• Women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amorepacific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miyoung Park, PhD

Role: STUDY_DIRECTOR

Amorepacific R&D Center

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AP-TRPV1_PII-02

Identifier Type: -

Identifier Source: org_study_id