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

Multi Center, Double-blind, Randomized, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Antipruritic Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Skin Pruritus Patients

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.

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