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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Amorepacific Corporation

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