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

Promius Pharma

Status and phase: Terminated; Phase 3

Conditions: Onychomycosis

Treatments: Drug: NAB001; Drug: Placebo control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01208129

0903

Details and patient eligibility

About

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.

Enrollment: 458 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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458 participants in 2 patient groups, including a placebo group

Active drug

Experimental group

Treatment:

Drug: NAB001

Vehicle alone

Placebo Comparator group

Treatment:

Drug: Placebo control