Status:
COMPLETED
Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
Lead Sponsor:
NanoBio Corporation
Conditions:
Onychomycosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Detailed Description
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Eligibility Criteria
Inclusion
- are healthy males or females between the ages of 18 and 75 years of age;
- have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
- positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
- refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
- are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;
Exclusion
- females who are pregnant, plan to become pregnant during the study, or are nursing a child;
- are hypersensitive to topical creams, ointments, medications, or surfactants;
- have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
- have taken any investigational drug within 4 weeks prior to the start of the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT00453271
Start Date
January 1 2007
End Date
October 1 2008
Last Update
May 23 2013
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
International Dermatology Research
Miami, Florida, United States, 33144
2
Northwest Clinical Trial
Boise, Idaho, United States, 83704
3
Welborne Clinic
Evansville, Indiana, United States, 47713
4
Michigan Center for Research Corp.
Clinton Township, Michigan, United States, 48038