Onychomycosis Clinical Trial
Verified date | June 2012 |
Source | Dow Pharmaceutical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ministry of Health |
Study type | Interventional |
The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Dow Pharmaceutical Sciences |
Mexico,
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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