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

Onychomycosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400594
• Other study ID #: HTU-520-US01
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2011
• Last updated: May 12, 2015
• Start date: July 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2015
• Source: Hisamitsu Pharmaceutical Co., Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• HTU-520 Patch
Terbinafine hydrochloride patch

Other:
• Placebo Patch
Treatment with Placebo Patch

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Akron	Ohio
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	Radiant Research, Inc.	Atlanta	Georgia
United States	Center for Clinical and Cosmetic Research	Aventura	Florida
United States	Radiant Research, Inc.	Birmingham	Alabama
United States	Total Skin and Beauty Dermatology Center	Birmingham	Alabama
United States	UAB Department of Dermatology	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Marta Rendon, MD, Skin Care Research, Inc.	Boca Raton	Florida
United States	Pab Clinical Research	Brandon	Florida
United States	Radiant Research, Inc.	Chicago	Illinois
United States	Group Health Associates, Tri-Health	Cincinnati	Ohio
United States	Dermatology Research Institute	Coral Gables	Florida
United States	Radiant Research, Inc.	Dallas	Texas
United States	Radiant Research, Inc.	Denver	Colorado
United States	Diagnamics, Inc.	Encinatas	California
United States	Assoc Foot Clinic & Surgery Specialists	Flint	Michigan
United States	University of Minnesota, Minnesota Clinical Study Center	Fridley	Minnesota
United States	Clinical Research Advantage, Inc.	Glendale	Arizona
United States	Callender center for Clinical Research	Glenn Dale	Maryland
United States	Silverton Skin Institute	Grand Blanc	Michigan
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Ameriderm Research	Jacksonville	Florida
United States	Derm Research, LLC	Louisville	Kentucky
United States	Lake Washington Foot & Ankle Center	Melbourne	Florida
United States	William P Coleman III, MD	Metairie	Louisiana
United States	Florida Academic Dermatology Center	Miami	Florida
United States	Central Sooner Research	Norman	Oklahoma
United States	Ameriderm Research	Ormond Beach	Florida
United States	Leavitt Medical Associates ofFL	Ormond Beach	Florida
United States	Society Hill Dermatology	Philadelphia	Pennsylvania
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	University of Pittsburg Medical Center, Department of Dermatology	Pittsburgh	Pennsylvania
United States	Radiant Research, Inc.	San Antonio	Texas
United States	Radiant Research	St. Louis	Missouri
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Coastal Podiatry Group	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hisamitsu Pharmaceutical Co., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.		48 Weeks	Yes