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

Last updated on March 22, 2018

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Study Location
Anacor Investigational Site
Tuscon, Arizona, 85741 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Onychomycosis of Toenails
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01270971
Pfizer
Completed
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

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Efficacy and Safety Evaluation 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: Quadruple (Participant, Care Provider, 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.
 
Completed
594
Not Provided
November 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01270971
AN2690-ONYC-301
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Lee Zane, MD, MAS Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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