Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

Phase 3

Terminated

• Conditions: Onychomycosis
• Interventions: Drug: NAB001; Drug: Placebo control

• Registration Number: NCT01208129
• Lead Sponsor: Promius Pharma, LLC

Brief Summary

The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-07
• Disposition First Submitted: 2013-07-08
• Disposition First Submitted QC: 2013-07-08
• Last Update Submitted: 2013-07-08
• Disposition First Posted: 2013-07-11
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

• mild to moderate fungal infection of the toenail as assessed by study doctor
• koh positive & dermatophyte culture positive at Visit 1
• general good health as assessed by study doctor

Exclusion Criteria

• severe fungal toenail infection
• prior use of antifungal drugs (wash-out allowed, duration varies on class)
• significant confounding conditions as assessed by study doctor
• pregnancy/lactation
• must forego nail salon procedures during study for at least ~60 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active drug	NAB001	-
Vehicle alone	Placebo control	-

Primary Outcome Measures

Name	Time	Method
Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.	Week 56 after 52 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (clear or almost clear).	Week 56

Trial Locations

Locations (23)

Radiant Research, Inc.; 🇺🇸 Greer, South Carolina, United States

Associated Foot & Ankle Specialists, LLC; 🇺🇸 Phoenix, Arkansas, United States

Family Foot Health Center; 🇺🇸 Rogers, Arkansas, United States

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

UCSF Dermatology Research; 🇺🇸 San Francisco, California, United States

Avail Clinical Research; 🇺🇸 DeLand, Florida, United States

North Florida Dermatology Association; 🇺🇸 Jacksonville, Florida, United States

Altus Research; 🇺🇸 Lake Worth, Florida, United States

Lake Washington Foot and Ankle Center; 🇺🇸 Melbourne, Florida, United States

Park Avenue Dermatology; 🇺🇸 Orange Park, Florida, United States

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