Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

NanoBio Corporation

Status and phase: Completed; Phase 2

Conditions: Onychomycosis

Treatments: Drug: Vehicle control; Drug: NB-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT00453271

NB-002-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 443 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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443 participants in 4 patient groups

NB-002 0.25% BID

Experimental group

Treatment:

Drug: NB-002

NB-002 0.5% QD

Experimental group

Treatment:

Drug: NB-002

NB-002 0.5% BID

Experimental group

Treatment:

Drug: NB-002

Vehicle control

Sham Comparator group

Treatment:

Drug: Vehicle control