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

Phase 2

Completed

• Conditions: Onychomycosis
• Interventions: Drug: HTU-520 Patch; Other: Placebo Patch

• Registration Number: NCT01400594
• Lead Sponsor: Hisamitsu Pharmaceutical Co., Inc.

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Disposition First Submitted: 2015-03-17
• Status Verified: 2015-05
• Disposition First Submitted QC: 2015-05-12
• Last Update Submitted: 2015-05-12
• Disposition First Posted: 2015-06-04
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

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

Exclusion Criteria

1. Unable to apply test product onto toenails by him/herself
2. Use of topical antifungal agents on the nail within 1 month
3. Uncontrolled diabetes
4. Onychomycosis of the fingernails
5. Confirmed non-dermatophyte infection of the target toenail
6. Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails
7. History of severe or chronic immunosuppression, an immunocompromised condition
8. Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis
9. Psoriasis of the toenails
10. Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTU-520 Patch	HTU-520 Patch	Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails.
Placebo Patch	Placebo Patch	Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.

Primary Outcome Measures

Name	Time	Method
Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.	48 Weeks

Trial Locations

Locations (27)

Radiant Research, Inc.; 🇺🇸 San Antonio, Texas, United States

Florida Academic Dermatology Center; 🇺🇸 Miami, Florida, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Society Hill Dermatology; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Minnesota, Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Group Health Associates, Tri-Health; 🇺🇸 Cincinnati, Ohio, United States

Callender center for Clinical Research; 🇺🇸 Glenn Dale, Maryland, United States

William P Coleman III, MD; 🇺🇸 Metairie, Louisiana, United States

UAB Department of Dermatology; 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Central Sooner Research; 🇺🇸 Norman, Oklahoma, United States

Assoc Foot Clinic & Surgery Specialists; 🇺🇸 Flint, Michigan, United States

Silverton Skin Institute; 🇺🇸 Grand Blanc, Michigan, United States

Total Skin and Beauty Dermatology Center; 🇺🇸 Birmingham, Alabama, United States

Diagnamics, Inc.; 🇺🇸 Encinatas, California, United States

Clinical Research Advantage, Inc.; 🇺🇸 Glendale, Arizona, United States

Center for Clinical and Cosmetic Research; 🇺🇸 Aventura, Florida, United States

Dermatology Research Institute; 🇺🇸 Coral Gables, Florida, United States

Pab Clinical Research; 🇺🇸 Brandon, Florida, United States

Ameriderm Research; 🇺🇸 Ormond Beach, Florida, United States

Lake Washington Foot & Ankle Center; 🇺🇸 Melbourne, Florida, United States

Leavitt Medical Associates ofFL; 🇺🇸 Ormond Beach, Florida, United States

Derm Research, LLC; 🇺🇸 Louisville, Kentucky, United States

University of Pittsburg Medical Center, Department of Dermatology; 🇺🇸 Pittsburgh, Pennsylvania, United States

Coastal Podiatry Group; 🇺🇸 Virginia Beach, Virginia, United States

Marta Rendon, MD, Skin Care Research, Inc.; 🇺🇸 Boca Raton, Florida, United States

Radiant Research; 🇺🇸 St. Louis, Missouri, United States