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

Completed · Phase 2 · Has a placebo group

Conditions studied: Onychomycosis

In brief

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.

Key facts

Study ID

NCT01400594

Run by

Hisamitsu Pharmaceutical Co., Inc.

People needed

182

Starts

2011-07-01

Expected to finish

2013-01-01

Last updated by the study team

2015-06-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Total Skin and Beauty Dermatology Center — Birmingham, Alabama, United States
• Radiant Research, Inc. — Birmingham, Alabama, United States
• UAB Department of Dermatology — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Clinical Research Advantage, Inc. — Glendale, Arizona, United States
• Radiant Research, Inc. — Tucson, Arizona, United States
• Diagnamics, Inc. — Encinatas, California, United States
• Radiant Research, Inc. — Denver, Colorado, United States
• Center for Clinical and Cosmetic Research — Aventura, Florida, United States
• Marta Rendon, MD, Skin Care Research, Inc. — Boca Raton, Florida, United States
• Pab Clinical Research — Brandon, Florida, United States
• Dermatology Research Institute — Coral Gables, Florida, United States
• Ameriderm Research — Jacksonville, Florida, United States
• Lake Washington Foot & Ankle Center — Melbourne, Florida, United States
• Florida Academic Dermatology Center — Miami, Florida, United States
• Ameriderm Research — Ormond Beach, Florida, United States
• Leavitt Medical Associates ofFL — Ormond Beach, Florida, United States
• Radiant Research, Inc. — Pinellas Park, Florida, United States
• Radiant Research, Inc. — Atlanta, Georgia, United States
• Radiant Research, Inc. — Chicago, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Derm Research, LLC — Louisville, Kentucky, United States
• William P Coleman III, MD — Metairie, Louisiana, United States
• Callender center for Clinical Research — Glenn Dale, Maryland, United States
• Assoc Foot Clinic & Surgery Specialists — Flint, Michigan, United States

Full record on ClinicalTrials.gov

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