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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Onychomycosis of Toenails

Treatments: Drug: Solution Vehicle; Drug: AN2690 Topical Solution, 5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01270971

AN2690-ONYC-301

Details and patient eligibility

About

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.

Enrollment: 594 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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594 participants in 2 patient groups, including a placebo group

AN2690 Topical Solution, 5%

Experimental group

Description:

AN2690 Topical Solution, 5%

Treatment:

Drug: AN2690 Topical Solution, 5%

Solution Vehicle

Placebo Comparator group

Description:

Solution Vehicle

Treatment:

Drug: Solution Vehicle