Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

Phase 3

Completed

• Conditions: Onychomycosis
• Interventions: Drug: IDP-108; Drug: Vehicle

• Registration Number: NCT01008033
• Lead Sponsor: Dow Pharmaceutical Sciences

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-05
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-20
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 870

Inclusion Criteria

• Clinically diagnosed onychomycosis of the target nail
• Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
• Has a positive KOH examination from the target nail
• Has a positive dermatophyte culture from the target nail

Exclusion Criteria

• Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
• Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
• Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDP-108	IDP-108	-
Vehicle	Vehicle	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients who achieve clinical cure	52 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who achieve clinical efficacy	52 weeks
Percentage of patients who achieve mycologic cure	52 weeks

Trial Locations

Locations (64)

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

University Clinical Trials, Inc; 🇺🇸 San Diego, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Longmont Medical Research Network; 🇺🇸 Longmont, Colorado, United States

The Savin Center, PC; 🇺🇸 New Haven, Connecticut, United States

Foot and Ankle Associates of Florida, Inc; 🇺🇸 Altamonte Springs, Florida, United States

International Dermatology Research, Inc.; 🇺🇸 Miami, Florida, United States

Ameriderm Research; 🇺🇸 Ormond Beach, Florida, United States

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