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Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01302119
First received: February 21, 2011
Last updated: January 23, 2013
Last verified: January 2013
History of Changes

February 21, 2011
January 23, 2013
February 2011
December 2012   (final data collection date for primary outcome measure)
Complete cure (completely clear nail and negative mycology) of target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01302119 on ClinicalTrials.gov Archive Site
  • Completely clear or almost clear target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Treatment success (completely clear or almost clear nail and negative mycology) of target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Negative mycology of target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events and local tolerability signs/symptoms in subjects treated for up to 48 weeks [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of AN2690 Topical Solution, 5%, vs. Solution Vehicle in the Treatment of Onychomycosis of the Toenail in Adults

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Onychomycosis of Toenails
  • Drug: AN2690 Topical Solution, 5%
    AN2690 Topical Solution, 5%, applied once daily for 48 weeks
  • Drug: Solution Vehicle
    AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
  • Experimental: AN2690 Topical Solution, 5%
    AN2690 Topical Solution, 5%
    Intervention: Drug: AN2690 Topical Solution, 5%
  • Placebo Comparator: Solution Vehicle
    Solution Vehicle
    Intervention: Drug: Solution Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
604
Not Provided
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail
  • KOH positive at screening
  • Willingness not to use any other products including nail polish applied to the toenails during the study
  • Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period

Exclusion Criteria:

  • Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
  • History of any significant chronic fungal disease other than onychomycosis
  • Significant confounding conditions as assessed by study doctor
  • Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
  • Pregnancy or lactation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01302119
AN2690-ONYC-302
No
Anacor Pharmaceuticals, Inc.
Anacor Pharmaceuticals, Inc.
Not Provided
Study Director: Lee Zane, MD, MAS Anacor Pharmaceuticals, Inc.
Anacor Pharmaceuticals, Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP