Clinical Trial: Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis

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

Official Title: An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)

Brief Summary:

Onychomycosis is a fungal infection that affects fingernails and/or toenails.

The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.

Detailed Summary:
Sponsor: Moberg Pharma AB

Current Primary Outcome: Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy. [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of patients with negative fungal culture, negative direct microscopy and complete cure. [ Time Frame: 1, 3, 6, 9, 12 months. ]

Original Secondary Outcome: Same as current

Information By: Moberg Pharma AB

Dates:
Date Received: November 19, 2010
Date Started: December 2010
Date Completion:
Last Updated: October 24, 2012
Last Verified: September 2011