Clinical Trial: Topical Aprepitant in Prurigo Patients

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

Official Title: Topical Aprepitant in Prurigo Patients An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

Brief Summary: Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

Detailed Summary:
Sponsor: LEO Pharma

Current Primary Outcome: efficacy of topical aprepitant treatment [ Time Frame: 4 weeks ]

To investigate the efficacy of topical treatment with aprepitant on pruritus compared to placebo, after 4 weeks of treatment using VAS (Visual Analogue Score)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • efficacy of topical applied aprepitant [ Time Frame: 4 weeks ]
    To assess efficacy of topical applied aprepitant on the status of the skin condition compared to placebo, after 4 weeks of treatment using patient global assessment and clinical score
  • long-term effect of topical applied aprepitant [ Time Frame: 6 weeks ]
    To assess long-term effect (e.g., duration of action, duration of reduction of pruritus) of topical applied aprepitant in comparison to placebo, after a follow up period of 2 weeks at the end of the treatment
  • effect of topical applied aprepitant on skin structures [ Time Frame: 4 weeks ]
    To assess effect of topical applied aprepitant on skin structures in comparison to placebo, after 4 weeks of treatment using TEWL (Transepidermal Water Loss)


Original Secondary Outcome: Same as current

Information By: LEO Pharma

Dates:
Date Received: September 18, 2013
Date Started: October 2013
Date Completion:
Last Updated: October 6, 2014
Last Verified: February 2014