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

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

Official Title: A Randomized, Double-blind, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Seborrhe

Brief Summary: This study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. 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: Treatment success rate in IGE(Investigator's Global Evaluation) [ Time Frame: Change from Baseline at Day 14 and Day 28 ]

Treatment success rate in IGE on 28th day from the baseline


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Erythema severity score [ Time Frame: Change from baseline at Day 14 and 28 ]
  • Change in Scale severity score [ Time Frame: Baseline, Day 14 and Day 28 ]
    Change from baseline at Day 14 and 28
  • Change in Visual Analogue Scale(VAS) score [ Time Frame: Change from baseline at Day 14 and 28 ]


Original Secondary Outcome: Same as current

Information By: Amorepacific Corporation

Dates:
Date Received: September 30, 2015
Date Started: February 2014
Date Completion:
Last Updated: April 20, 2016
Last Verified: April 2016