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 range18 Years – 65 Years

SexALL

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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.
✕. Subjects with chronic moccasin type of T. pedis.
✕. Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis.
✕. Subjects unwilling to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers from the screening visit until the end of the study.
✕. Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications:
✕. Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
✕. Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks

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