Clinical Trial: Evaluation of the Antipruritic Effect of PAC-14028 Cream in Skin Pruritus

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

Official Title: A Phase II, Single Center, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of PAC-14028 Cream in Dermal Pruritus

Brief Summary: The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific Corporation in patients with dermal pruritus.

Detailed Summary:
Sponsor: Amorepacific Corporation

Current Primary Outcome: Change in Visual Analog Scale (VAS) [ Time Frame: Baseline through Study Day 28 ]

Patient reported outcome of pruritis measurement on a change in visual analog scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Treatment success rate [ Time Frame: Baseline through Study Day 28 ]
  • Change in specified symptom sum score (SRRC) Index [ Time Frame: Baseline through Study Day 28 ]
  • Change in transepidermal water loss [ Time Frame: Baseline through Study Day 28 ]
  • Change in skin hydration [ Time Frame: Baseline through Study Day 28 ]


Original Secondary Outcome: Same as current

Information By: Amorepacific Corporation

Dates:
Date Received: January 31, 2014
Date Started: January 2013
Date Completion:
Last Updated: September 11, 2015
Last Verified: September 2015