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

Phase 3

Completed

• Conditions: Onychomycosis of Toenails
• Interventions: Drug: AN2690 Topical Solution, 5%; Drug: Solution Vehicle

• Registration Number: NCT01302119
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-21
• Study First Posted: 2011-02-23
• Disposition First Submitted: 2012-07-26
• Disposition First Submitted QC: 2012-07-26
• Disposition First Posted: 2012-08-02
• Primary Completion: 2012-12-31
• Study Completion: 2013-02-20
• Results First Submitted: 2014-07-25
• Results First Submitted QC: 2014-07-25
• Results First Posted: 2014-08-15
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AN2690 Topical Solution, 5%	AN2690 Topical Solution, 5%	AN2690 Topical Solution, 5%
Solution Vehicle	Solution Vehicle	Solution Vehicle

Primary Outcome Measures

Name	Time	Method
Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52	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.

Secondary Outcome Measures

Name	Time	Method
Completely Clear or Almost Clear Target Great Toenail at Week 52	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	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	Week 52	Negative KOH and negative fungal culture.

Trial Locations

Locations (1)

Investigational Site; 🇨🇦 Quebec, Canada