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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777868
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences

Study Description
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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

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: Low Strength IDP-108 Drug: High Strength IDP-108 Drug: High Strength IDP-108 under occlusion Drug: Vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Low Strength IDP-108
Topical application once a day for 9 months
Experimental: 2 Drug: High Strength IDP-108
Topical application once a day for 9 months
Experimental: 3 Drug: High Strength IDP-108 under occlusion
Topical application once a day for 9 months
Placebo Comparator: 4 Drug: Vehicle
Topical application once a day for 9 months


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in area of infected nail [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Change from baseline in mycological results [ Time Frame: 9 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777868


Locations
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Mexico
Clinical Research Institute
Mexico City, Federal District, Mexico, CP54055
Hospital Central Militar
Mexico City, Federal District, Mexico
Hospital General de México
México City, Federal District, Mexico, CP 06726
Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio"
Guadalajara, Jalisco, Mexico, CP45190
Hospital Dr. Ángel Leaño
Zapopan, Jalisco, Mexico, CP45200
MIRC/OCA Hospital
Monterrey, Nuevo León, Mexico, CP64000
Centro de Dermatología de Monterrey
Monterrey, Nuevo León, Mexico, CP64460
Hospital Universitario "José E. González"
Monterrey, Nuevo León, Mexico, CP64460
Unidad de Investigación en Salud
Chihuahua, Mexico, CP31205
Hospital Ignacio Morones Prieto SLP
San Luis Potosí, Mexico, CP 78240
Sponsors and Collaborators
Dow Pharmaceutical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00777868    
Other Study ID Numbers: DPSI-IDP-108-P2-01
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases