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

NCT01270971

Last updated date
Study Location
Investigational Site
Tucson, Arizona, 85741, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

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[email protected]

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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

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[email protected]

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Onychomycosis of ToenailsEfficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
NCT01270971
  1. Tucson, Arizona
  2. Hot Springs, Arkansas
  3. Burbank, California
  4. Los Angeles, California
  5. San Francisco, California
  6. Denver, Colorado
  7. Orange Park, Florida
  8. Boise, Idaho
  9. Evansville, Indiana
  10. Overland Park, Kansas
  11. Baltimore, Maryland
  12. Fridley, Minnesota
  13. Omaha, Nebraska
  14. New York, New York
  15. New York, New York
  16. Rochester, New York
  17. Winston-Salem, North Carolina
  18. Cincinnati, Ohio
  19. South Euclid, Ohio
  20. Portland, Oregon
  21. Providence, Rhode Island
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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis of Toenails
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2012)
594
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2011)
600
Actual Study Completion Date  ICMJE January 8, 2013
Actual Primary Completion Date November 30, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01270971
Other Study ID Numbers  ICMJE AN2690-ONYC-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:PfizerCT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2019

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