Clinical Trial: Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail

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

Official Title: A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual On

Brief Summary: This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.

Detailed Summary: A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
Sponsor: Hisamitsu Pharmaceutical Co., Inc.

Current Primary Outcome: Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail. [ Time Frame: 48 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hisamitsu Pharmaceutical Co., Inc.

Dates:
Date Received: July 20, 2011
Date Started: July 2011
Date Completion:
Last Updated: May 12, 2015
Last Verified: May 2015