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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Dow Pharmaceutical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014