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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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.

Detailed Summary:
Sponsor: Amorepacific Corporation

Current Primary Outcome: Change in intensity of pruritus as measured by 10 cm VAS [ Time Frame: Week 4 from baseline ]

Original Primary Outcome: Change in intensity of pruritus as measured by 10 cm VAS [ Time Frame: Week 4 from baseline ]

Change in intensity of pruritus as measured by 10 cm VAS on Day 28 from baseline


Current Secondary Outcome:

  • Treatment success rate (A decrease in VAS by 2 or more is judged as a success) [ Time Frame: Week 4 from baseline ]
  • Change in Overall Dry Skin (ODS) score [ Time Frame: Week 4 from baseline ]
  • Change in Transepidermal Water Loss (TEWL) [ Time Frame: Week 4 from baseline ]


Original Secondary Outcome: Same as current

Information By: Amorepacific Corporation

Dates:
Date Received: September 30, 2015
Date Started: October 2014
Date Completion:
Last Updated: July 14, 2016
Last Verified: July 2016