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Trial record 1 of 1 for:    NCT01302119
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Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

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ClinicalTrials.gov Identifier: NCT01302119
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : August 15, 2014
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 21, 2011
First Posted Date  ICMJE February 23, 2011
Results First Submitted Date  ICMJE July 25, 2014
Results First Posted Date  ICMJE August 15, 2014
Last Update Posted Date April 3, 2019
Study Start Date  ICMJE February 2011
Actual Primary Completion Date December 31, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2011)
Complete cure (completely clear nail and negative mycology) of target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
  • 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.
  • 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.
  • Negative Mycology of Target Great Toenail at Week 52 [ Time Frame: Week 52 ]
    Negative KOH and negative fungal culture.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2011)
  • Completely clear or almost clear target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ]
  • Treatment success (completely clear or almost clear nail and negative mycology) of target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ]
  • Negative mycology of target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • 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)
604
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2011)
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:

  • 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 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
Study Director: PfizerCT.gov Call Center Pfizer
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