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Completed

NCT Number: NCT01400594

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

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.

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiant Research, Inc., Birmingham, Alabama, United States

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About this study

A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Who can participate

Healthy volunteers accepted: No

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

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
  • Psoriasis of the toenails
  • Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings

Treatment and study plan

HTU-520 Patch

Drug

Terbinafine hydrochloride patch

Other names: HTU-520

Placebo patch

Other

Treatment with Placebo Patch

Other names: Sham treatment

Primary outcomes

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

    Time frame: 48 Weeks

Sponsors and collaborators

Lead sponsor

Hisamitsu Pharmaceutical Co., Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 22, 2011
Registry last updated
Jun 4, 2015

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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