Phase 3
N=594
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
Onychomycosis of Toenails
Bottom Line
View on ClinicalTrials.gov: NCT01270971 ↗Enrolled (actual)
594
Serious AEs
3.4%
Results posted
Aug 2014
Primary outcome: Primary: Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 — 26; 1; 373; 193 participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AN2690 Topical Solution, 5% (Drug); Solution Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 |
26; 1; 373; 193 | 0.001 sig |
| SECONDARY Completely Clear or Almost Clear Target Great Toenail at Week 52 |
104; 18; 295; 176 | <0.001 sig |
| SECONDARY Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 |
61; 3; 338; 191 | <0.001 sig |
| SECONDARY Negative Mycology of Target Great Toenail at Week 52 |
124; 14; 275; 180 | <0.001 sig |
Summary
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01270971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.