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

Phase 2

Completed

• Conditions: Onychomycosis
• Interventions: Drug: Low Strength IDP-108; Drug: High Strength IDP-108 under occlusion; Drug: Vehicle; Drug: High Strength IDP-108

• Registration Number: NCT00777868
• Lead Sponsor: Dow Pharmaceutical Sciences

Brief Summary

The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-22
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-20
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Low Strength IDP-108	-
3	High Strength IDP-108 under occlusion	-
4	Vehicle	-
2	High Strength IDP-108	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in area of infected nail	9 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mycological results	9 months

Trial Locations

Locations (10)

Centro de Dermatología de Monterrey; 🇲🇽 Monterrey, Nuevo León, Mexico

Unidad de Investigación en Salud; 🇲🇽 Chihuahua, Mexico

Hospital Ignacio Morones Prieto SLP; 🇲🇽 San Luis Potosí, Mexico

Hospital Universitario "José E. González"; 🇲🇽 Monterrey, Nuevo León, Mexico

Hospital General de México; 🇲🇽 México City, Federal District, Mexico

Clinical Research Institute; 🇲🇽 Mexico City, Federal District, Mexico

Hospital Central Militar; 🇲🇽 Mexico City, Federal District, Mexico

Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio"; 🇲🇽 Guadalajara, Jalisco, Mexico

Hospital Dr. Ángel Leaño; 🇲🇽 Zapopan, Jalisco, Mexico

MIRC/OCA Hospital; 🇲🇽 Monterrey, Nuevo León, Mexico