CompletedPhase 2

Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail

United States182 participantsStarted 2011-07

Plain-language summary

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Clinical diagnosis of DSO for at least one great toenail
✓. Direct microscopy of subungual debris positive for hyphal elements (KOH test)
✓. Culture confirmation of the growth of a dermatophyte
✓. Good general health
✓. Willing to refrain from using any lotions, creams, liquids, or polish on treated toenails
✓. Willing to refrain from receiving pedicures for the duration of the study
✓. If female, using an acceptable form of birth control

Exclusion criteria

✕. Unable to apply test product onto toenails by him/herself
✕. Use of topical antifungal agents on the nail within 1 month
✕. Uncontrolled diabetes
✕. Onychomycosis of the fingernails
✕. Confirmed non-dermatophyte infection of the target toenail
✕. Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails
✕. History of severe or chronic immunosuppression, an immunocompromised condition
✕. Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis

What they're measuring

Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.

Timeframe: 48 Weeks

Trial details

NCT IDNCT01400594

SponsorHisamitsu Pharmaceutical Co., Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-01

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