Clinical Trial: A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of PF-045 and PF-055 for the Treatment of Scabies

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

Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison Study of the Safety and Efficacy of PF-055 Versus PF-045 Versus Vehicle in Subjects With Sarcoptes Scabiei

Brief Summary: To determine and compare the safety and efficacy of PF-045 and PF-055 with that of vehicle in subjects with scabies. It is anticipated that a majority of subjects will require and receive a single treatment; however, those subjects not showing improvement at the follow-up visit 2 weeks after initial treatment will be treated a second time. Those subjects originally assigned to vehicle for the first treatment will receive a "re-treatment" with one of the active doses.

Detailed Summary:
Sponsor: Renaissance Pharma, Inc.

Current Primary Outcome: Proportion of subjects designated as "treatment success" [ Time Frame: Day 28 ]

"Treatment success" is defined as achieving an Investigator Global Assessment (IGA) score of 0 or 1 at Day 28 (i.e., following a single full-body treatment). IGA measures scabies disease status on a 5-point scale (0=clear to 4=severe).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in disease-related signs and symptoms [ Time Frame: Baseline, Day 14, 28, and 42 ]
    The change in the signs/symptoms related to the disease in each treatment group at Days 14 and 28, as well as at Day 42 for those subjects provided with re-treatment at Day 14 who show improvement in their IGA score at Day 28.
  • Proportion of re-treated subjects designated as "treatment success" [ Time Frame: Day 42 ]
    The proportion of subjects re-treated at Day 14 designated as "treatment success" (IGA score of 0 or 1) at Day 42.
  • Proportion of subjects designated as "treatment success" following one treatment with an active dose [ Time Frame: Day 28 and Day 42 ]
    The proportion of subjects designated as "treatment success" (IGA score of 0 or 1) following one treatment versus two treatments. Subjects originally assigned to vehicle treatment and re-treated on Day 14 with an active dose will be included with the single treatment group for this analysis.


Original Secondary Outcome: Same as current

Information By: Renaissance Pharma, Inc.

Dates:
Date Received: March 20, 2014
Date Started: March 2014
Date Completion:
Last Updated: October 3, 2016
Last Verified: October 2016