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The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

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ClinicalTrials.gov Identifier: NCT01007708
Recruitment Status : Completed
First Posted : November 4, 2009
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 evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: IDP-108 Drug: Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: IDP-108 Drug: IDP-108
Topical application once a day for 48 weeks
Placebo Comparator: Vehicle Drug: Vehicle
Topical application once a day for 48 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients who achieve clinical cure [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients who achieve clinical efficacy [ Time Frame: 52 weeks ]
  2. Percentage of patients who achieve mycologic cure [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically diagnosed onychomycosis of the target nail
  • Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
  • Has a positive KOH examination from the target nail
  • Has a positive dermatophyte culture from the target nail

Exclusion Criteria:

  • Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
  • Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
  • Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
  • Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
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): NCT01007708


Locations
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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: NCT01007708    
Other Study ID Numbers: DPSI-IDP-108-P3-02
First Posted: November 4, 2009    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