NCT02565134

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Amorepacific Corporation · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	PAC-14028 cream 0.1%	Topical application
DRUG	PAC-14028 cream 0.3%	Topical application
DRUG	PAC-14028 cream 1.0%	Topical application
DRUG	PAC-14028 cream vehicle	Topical application

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2015-10-01
• Last updated: 2016-07-15

Locations

1 site across 1 country: South Korea