Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
NCT01302119
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- 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
- 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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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy and Safety 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 |
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Study Arms ICMJE |
| |||
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 | 604 | |||
Original Estimated Enrollment ICMJE | 600 | |||
Actual Study Completion Date ICMJE | February 20, 2013 | |||
Actual Primary Completion Date | December 31, 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
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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 | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01302119 | |||
Other Study ID Numbers ICMJE | AN2690-ONYC-302 | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |