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Completed

NCT Number: NCT01270971

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

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

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Key information

Conditions

Onychomycosis of Toenails Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatomycoses Foot Dermatoses Foot Diseases Genetic Diseases, Inborn Infections Keratoderma, Palmoplantar Keratoderma, Palmoplantar, Diffuse Keratoderma, Palmoplantar, Epidermolytic Keratosis Mycoses Nail Diseases Nails, Malformed Onycholysis Onychomycosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin Diseases, Genetic Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea Twenty-Nail Dystrophy Yellow Nail Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AN2690 Topical Solution, 5%

Drug

AN2690 Topical Solution, 5%, applied once daily for 48 weeks

Solution Vehicle

Drug

AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Negative Mycology of Target Great Toenail at Week 52

    Time frame: Week 52

    Negative KOH and negative fungal culture.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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 Toenail in Adults

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jan 6, 2011
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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