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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT01007708
First received: November 3, 2009
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Onychomycosis
Drug: IDP-108
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Further study details as provided by Dow Pharmaceutical Sciences:

Primary Outcome Measures:
  • Percentage of patients who achieve clinical cure [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients who achieve clinical efficacy [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who achieve mycologic cure [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 780
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007708

  Show 44 Study Locations
Sponsors and Collaborators
Dow Pharmaceutical Sciences
  More Information

No publications provided

Responsible Party: Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT01007708     History of Changes
Other Study ID Numbers: DPSI-IDP-108-P3-02
Study First Received: November 3, 2009
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014