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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01270971
First received: January 3, 2011
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.


Condition Intervention Phase
Onychomycosis of Toenails
Drug: AN2690 Topical Solution, 5%
Drug: Solution Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 594
Study Start Date: December 2010
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%
Drug: AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%, applied once daily for 48 weeks
Placebo Comparator: Solution Vehicle
Solution Vehicle
Drug: Solution Vehicle
AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270971

  Show 27 Study Locations
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Study Director: Lee Zane, MD, MAS Anacor Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01270971     History of Changes
Other Study ID Numbers: AN2690-ONYC-301
Study First Received: January 3, 2011
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Anacor Pharmaceuticals, Inc.:
Onychomycosis
nail fungus
toenail fungus
fungal nail
hyperkeratosis
nail infection
nail treatment
toenail infection
toenail treatment
foot dermatoses
fungal culture
onycholysis
podiatrist
podiatry
subungual
tinea unguium
antifungal
anti-fungal
dermatologist
dermatology
dermatophyte
distal subungual onychomycosis
yellow nail
thick nail
brittle nail
crumbling nail
discolored nail
weak nail

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