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Completed

NCT Number: NCT01008033

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

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.

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kirk Barber Research, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IDP-108

Drug

Topical application once a day for 48 weeks

Vehicle

Drug

Topical application once a day for 48 weeks

Primary outcomes

  1. Percentage of patients who achieve clinical cure

    Time frame: 52 weeks

Secondary outcomes

  1. Percentage of patients who achieve clinical efficacy

    Time frame: 52 weeks

  2. Percentage of patients who achieve mycologic cure

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Dow Pharmaceutical Sciences

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 5, 2009
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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