CompletedPhase 2

Study of Different Doses of a Novel Treatment for Onychomycosis

Mexico159 participantsStarted 2006-02-28

Plain-language summary

The purpose of the study is to determine the safety and efficacy of 2.5%, 5.0%, and 7.5% AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual onychomycosis of the great target toenail.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee.
. Male or female subjects of any race at least 18 years of age but not older than 65 years of age.
. Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount and a positive fungal culture for a dermatophyte.
. Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day 1) by visual inspection after the nail has been trimmed.
. The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed \< 3 mm.
. Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth.
. Normal or not clinically significant screening safety labs.

Exclusion criteria

. Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study.
. Diabetes mellitus requiring treatment other than diet and exercise.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical evidence of complete great toenail clearance or at least fungal-clear great toenail growth ("complete" = 5mm; "partial" = 2mm), plus a negative fungal culture from the treatment-targeted great toenail.

Timeframe: Day 180

Trial details

NCT IDNCT00679965

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-07-31

View on ClinicalTrials.gov More Distal, Subungual Onychomycosis trials