Clinical Trial: Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Toe

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: 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: Complete cure (completely clear nail and negative mycology) of target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ]

Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: Pfizer

Dates:
Date Received: February 21, 2011
Date Started: February 2011
Date Completion:
Last Updated: July 25, 2014
Last Verified: July 2014