A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
NCT ID: NCT00777868
Last Updated: 2012-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2007-10-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Low Strength IDP-108
Topical application once a day for 9 months
2
High Strength IDP-108
Topical application once a day for 9 months
3
High Strength IDP-108 under occlusion
Topical application once a day for 9 months
4
Vehicle
Topical application once a day for 9 months
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* A positive fungal culture from the target toenail
Exclusion Criteria
* Presence of tinea pedis (athletes foot)
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
18 Years
65 Years
ALL
No
Sponsors
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Dow Pharmaceutical Sciences
INDUSTRY
Responsible Party
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Locations
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Unidad de Investigación en Salud
Chihuahua City, Chihuahua, Mexico
Clinical Research Institute
Mexico City, Federal District, Mexico
Hospital Central Militar
Mexico City, Federal District, Mexico
Hospital General de México
México, 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
Centro de Dermatología de Monterrey
Monterrey, Nuevo León, Mexico
Hospital Universitario "José E. González"
Monterrey, Nuevo León, Mexico
Hospital Ignacio Morones Prieto SLP
San Luis Potosí City, San Luis Potosí, Mexico
Countries
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References
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Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R. Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol. 2013 Feb;12(2):186-92.
Other Identifiers
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DPSI-IDP-108-P2-01
Identifier Type: -
Identifier Source: org_study_id
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