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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01270971
Recruitment Status : Completed
First Posted : January 6, 2011
Results First Posted : August 15, 2014
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 594 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : December 1, 2010
Actual Primary Completion Date : November 30, 2012
Actual Study Completion Date : January 8, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tavaborole

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 [ Time Frame: Week 52 ]
    No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.


Secondary Outcome Measures :
  1. Completely Clear or Almost Clear Target Great Toenail at Week 52 [ Time Frame: Week 52 ]
    No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.

  2. Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 [ Time Frame: Week 52 ]
    No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.

  3. Negative Mycology of Target Great Toenail at Week 52 [ Time Frame: Week 52 ]
    Negative KOH and negative fungal culture.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01270971


  Show 27 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: PfizerCT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain further information about a study center near you, click here to visit www.toenailstudy.com  This link exits the ClinicalTrials.gov site

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01270971     History of Changes
Other Study ID Numbers: AN2690-ONYC-301
First Posted: January 6, 2011    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: February 22, 2019
Last Verified: February 2019
Keywords provided by Pfizer:
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:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
 Nail Diseases
Skin Diseases
Tavaborole
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents