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Completed

NCT Number: NCT00777868

A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis

The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Unidad de Investigación en Salud, Chihuahua City, Chihuahua, Mexico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of onychomycosis of the target toenail
  • A positive fungal culture from the target toenail

Exclusion criteria

  • Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations
  • Presence of tinea pedis (athletes foot)
  • Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Treatment and study plan

Low Strength IDP-108

Drug

Topical application once a day for 9 months

High Strength IDP-108

Drug

Topical application once a day for 9 months

High Strength IDP-108 under occlusion

Drug

Topical application once a day for 9 months

Vehicle

Drug

Topical application once a day for 9 months

Primary outcomes

  1. Change from baseline in area of infected nail

    Time frame: 9 months

Secondary outcomes

  1. Change from baseline in mycological results

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Dow Pharmaceutical Sciences

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 22, 2008
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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