Clinical Trial: TDT 067 Onychomycosis Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Double-blind, Vehicle- and Placebo-Controlled, Multicenter Trial in Patients With Mild to Moderate Distal Subungual Toenail Onychomycosis to Investigate the

Brief Summary: The aim of this study is to establish the efficacy, clinical benefits, and safety of treatment with TDT 067 for clinically diagnosed distal subungual onychomycosis of the toenails caused by dermatophytes confirmed by positive mycology.

Detailed Summary:
Sponsor: Celtic Pharma Development Services

Current Primary Outcome: Cure Rate [ Time Frame: 52 Weeks ]

To compare complete cure rates for onychomycosis at Week 52 for TDT 067 versus non-Transfersome placebo.

If the comparison between TDT 067 and non-Transfersome placebo is statistically significant in favor of TDT 067, the following additional primary efficacy objective:

To compare onychomycosis cure rates at Week 52 for TDT 067 versus Transfersome vehicle



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cure Rate 48 [ Time Frame: 48 Weeks ]

    Compare onychomycosis complete cure rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle

    Compare effective treatment rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle

    Compare mycological cure rates at Wk 48 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle

    Compare complete cure rates at Wk 48 effective treatment rates at Wks 48, and mycological cure rates at Wks 48 for Transfersome® vehicle versus non Transfersome® placebo

  • Cure Rate 52 [ Time Frame: 52 Weeks ]

    Compare onychomycosis complete cure rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle

    Compare effective treatment rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle

    Compare mycological cure rates at Wk 52 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle

    Compare complete cure rates at Wk 52 effective treatment rates at Wk 52 and mycological cure rates at Wk 52 for Transfersome® vehicle versus non Transfersome® placebo

  • Cure Rate 60 [ Time Frame: 60 Weeks ]

    Compare onychomycosis complete cure rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle

    Compare effective treatment rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle

    Compare mycological cure rates at Wk 60 for TDT 067 versus non Transfersome® placebo and Transfersome® vehicle

    Compare complete cure rates at Wk 60, effective treatment rates at Wk 60, and mycological cure rates at Wk 60 for Transfersome® vehicle versus non Transfersome® placebo



Original Secondary Outcome: Same as current

Information By: Celtic Pharma Development Services

Dates:
Date Received: March 19, 2010
Date Started: April 2010
Date Completion: August 2012
Last Updated: July 31, 2012
Last Verified: July 2012