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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01208168
Other study ID # 0904
Secondary ID
Status Terminated
Phase Phase 3
First received September 20, 2010
Last updated July 8, 2013
Start date September 2010
Est. completion date July 2012

Study information

Verified date July 2013
Source Promius Pharma, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 468
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- mild to moderate fungal infection of the toenail as assessed by study doctor

- koh positive & dermatophyte culture positive at Visit 1

- good general health as assessed by the 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
NAB001
nail lacquer, once daily, 52 weeks
Vehicle alone
nail lacquer, once daily, 52 weeks

Locations

Country Name City State
Dominican Republic Instituto Dermatologica Santo Domingo
Dominican Republic Instituto Dermatologico Santo Domingo
United States Northwest Clinical Trials Boise Idaho
United States Radiant Research Cincinnati Ohio
United States Ashton Podiatry Associates, PA Dallas Texas
United States Gerard Furst, DPM, PLLC East Setauket New York
United States T. Joseph Raoof, MD, Inc. Encino California
United States Minnesota Clinical Study Center Fridley Minnesota
United States Carolina Dermatology of Greenville, PA Greenville South Carolina
United States Dermatology Consulting Services High Point North Carolina
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States Longmont Medical Research Network Longmont Colorado
United States Internaional Dermatology Research, Inc. Miami Florida
United States Coastal Carolina Research Center Mt. Pleasant South Carolina
United States Tennessee Clinical Research Center Nashville Tennessee
United States MedaPhase, Inc. Newnan Georgia
United States Temple University - School of Podiatric Medicine Philadelphia Pennsylvania
United States Oregon Dermatology & Research Network Portland Oregon
United States Wake Research Associates Raleigh North Carolina
United States Mazur Foot and Ankle Salisbury North Carolina
United States Progressive Clinical Research San Antonio Texas
United States Skin Surgery Medical Group, Inc. San Diego California
United States Clinical Research Atlanta Stockbridge Georgia

Sponsors (1)

Lead Sponsor Collaborator
Promius Pharma, LLC

Countries where clinical trial is conducted

United States,  Dominican Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure. Week 56 after 52 weeks of treatment No
Secondary 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 No
See also
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Recruiting NCT01666002 - Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser N/A
Terminated NCT01208129 - Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails Phase 3
Completed NCT01180491 - A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis N/A
Completed NCT00385502 - A Trial of the Safety and Efficacy of EcoNailâ„¢ in the Treatment of Fungus Infections of the Great Toenail Phase 2
Completed NCT00253305 - Topical Gel Anti-Fungal Agent for Tinea Unguium Phase 2
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Completed NCT03405818 - An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents Phase 4
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Withdrawn NCT00938925 - Effectiveness of Podiatry Care on Onychomycosis (EPOCAON) N/A
Recruiting NCT00808366 - Efficacy and Safety of RV4104A Ointment in Onychomycosis N/A
Completed NCT00768768 - Iontophoretic Application of Terbinafine Gel to the Large Toe Nail Phase 1
Completed NCT00781820 - Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste Phase 3
Completed NCT00777868 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis Phase 2
Recruiting NCT06074315 - Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis N/A
Completed NCT01039883 - A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule Phase 1
Suspended NCT05491603 - A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis Phase 2