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NCT00777868 Clinical Trial

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

Onychomycosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00777868
Other study ID # DPSI-IDP-108-P2-01
Secondary ID
Status Completed
Phase Phase 2
First received October 20, 2008
Last updated June 20, 2012
Start date October 2007
Est. completion date April 2009

Study information
Verified date June 2012
Source Dow Pharmaceutical Sciences
Contact n/a
Is FDA regulated No
Health authority Mexico: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 135
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• Low Strength IDP-108
Topical application once a day for 9 months
• High Strength IDP-108
Topical application once a day for 9 months
• High Strength IDP-108 under occlusion
Topical application once a day for 9 months
• Vehicle
Topical application once a day for 9 months

Locations
Country Name City State
Mexico Unidad de Investigación en Salud Chihuahua
Mexico Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio" Guadalajara Jalisco
Mexico Clinical Research Institute Mexico City Federal District
Mexico Hospital Central Militar Mexico City Federal District
Mexico Hospital General de México México City Federal District
Mexico Centro de Dermatología de Monterrey Monterrey Nuevo León
Mexico Hospital Universitario "José E. González" Monterrey Nuevo León
Mexico MIRC/OCA Hospital Monterrey Nuevo León
Mexico Hospital Ignacio Morones Prieto SLP San Luis Potosí
Mexico Hospital Dr. Ángel Leaño Zapopan Jalisco

Sponsors (1)
Lead Sponsor Collaborator
Dow Pharmaceutical Sciences

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in area of infected nail 9 months No
Secondary Change from baseline in mycological results 9 months No
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