A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
1 other identifier
interventional
135
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 20, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJune 22, 2012
June 1, 2012
1.5 years
October 20, 2008
June 20, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in area of infected nail
9 months
Secondary Outcomes (1)
Change from baseline in mycological results
9 months
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Presence of onychomycosis of the target toenail
- A positive fungal culture from the target toenail
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unidad de Investigación en Salud
Chihuahua City, Chihuahua, CP31205, Mexico
Clinical Research Institute
Mexico City, Federal District, CP54055, Mexico
Hospital Central Militar
Mexico City, Federal District, Mexico
Hospital General de México
México, Federal District, CP 06726, Mexico
Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio"
Guadalajara, Jalisco, CP45190, Mexico
Hospital Dr. Ángel Leaño
Zapopan, Jalisco, CP45200, Mexico
MIRC/OCA Hospital
Monterrey, Nuevo León, CP64000, Mexico
Centro de Dermatología de Monterrey
Monterrey, Nuevo León, CP64460, Mexico
Hospital Universitario "José E. González"
Monterrey, Nuevo León, CP64460, Mexico
Hospital Ignacio Morones Prieto SLP
San Luis Potosí City, San Luis Potosí, CP 78240, Mexico
Related Publications (1)
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.
PMID: 23377392DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2008
First Posted
October 22, 2008
Study Start
October 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
June 22, 2012
Record last verified: 2012-06