Clinical trial NCT01400594: Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Keywords: Onychomycosis
Lead sponsor: Hisamitsu Pharmaceutical Co., Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.
timeFrame: 48 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center
state: Alabama
city: Birmingham
country: United States
facility: Radiant Research, Inc.
state: Alabama
city: Birmingham
country: United States
facility: UAB Department of Dermatology
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Glendale
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Encinatas
country: United States
facility: Diagnamics, Inc.
state: California
city: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
city: Boca Raton
country: United States
facility: Marta Rendon, MD, Skin Care Research, Inc.
state: Florida
city: Brandon
country: United States
facility: Pab Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Dermatology Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Ameriderm Research
state: Florida
city: Melbourne
country: United States
facility: Lake Washington Foot & Ankle Center
state: Florida
city: Miami
country: United States
facility: Florida Academic Dermatology Center
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates ofFL
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Radiant Research, Inc.
state: Georgia
city: Chicago
country: United States
facility: Radiant Research, Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: Derm Research, LLC
state: Kentucky
city: Metairie
country: United States
facility: William P Coleman III, MD
state: Louisiana
city: Glenn Dale
country: United States
facility: Callender center for Clinical Research
state: Maryland
city: Flint
country: United States
facility: Assoc Foot Clinic & Surgery Specialists
state: Michigan
city: Grand Blanc
country: United States
facility: Silverton Skin Institute
state: Michigan
city: Fridley
country: United States
facility: University of Minnesota, Minnesota Clinical Study Center
state: Minnesota
city: St. Louis
country: United States
facility: Radiant Research
state: Missouri
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Group Health Associates, Tri-Health
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Society Hill Dermatology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center, Department of Dermatology
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Dallas
country: United States
facility: Radiant Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Virginia Beach
country: United States
facility: Coastal Podiatry Group
state: Virginia
Study officials:
name: Donald Sislen, MD
role: PRINCIPAL_INVESTIGATOR
name: Susan Taylor, MD
role: PRINCIPAL_INVESTIGATOR
name: Melanic Appell, MD
role: PRINCIPAL_INVESTIGATOR
name: Harry I. Geisberg, MD
role: PRINCIPAL_INVESTIGATOR
name: Michele D. Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
name: Linda P. Murray, MD
role: PRINCIPAL_INVESTIGATOR
name: Michael P. Kyle, MD
role: PRINCIPAL_INVESTIGATOR
name: Kenneth W. Dawes, MD
role: PRINCIPAL_INVESTIGATOR
name: Hassan Malik, MD
role: PRINCIPAL_INVESTIGATOR
name: Francisco A. Kerdel, MD
role: PRINCIPAL_INVESTIGATOR
name: Leon Kircik, MD
role: PRINCIPAL_INVESTIGATOR
name: Mark S. Nestor, MD
role: PRINCIPAL_INVESTIGATOR
name: Douglas N. Robins, MD
role: PRINCIPAL_INVESTIGATOR
name: Pranav B. Sheth, MD
role: PRINCIPAL_INVESTIGATOR
name: Martin Throne, MD
role: PRINCIPAL_INVESTIGATOR
name: Patrick S. Agnew, MD
role: PRINCIPAL_INVESTIGATOR
name: David Bolshoun, MD
role: PRINCIPAL_INVESTIGATOR
name: Gordon T. Connor, MD
role: PRINCIPAL_INVESTIGATOR
name: Boni Elewski, MD
role: PRINCIPAL_INVESTIGATOR
name: Laura Ferris, MD
role: PRINCIPAL_INVESTIGATOR
name: Steven E. Kempers, MD
role: PRINCIPAL_INVESTIGATOR
name: Daniel G. Lorch, MD
role: PRINCIPAL_INVESTIGATOR
name: James A. Solomon, MD
role: PRINCIPAL_INVESTIGATOR
name: Norman Bystol, MD
role: PRINCIPAL_INVESTIGATOR
name: William P. Coleman, MD
role: PRINCIPAL_INVESTIGATOR
name: Paul Gillum, MD
role: PRINCIPAL_INVESTIGATOR
name: William P. Jennings, MD
role: PRINCIPAL_INVESTIGATOR
name: Ramin Farsad, MD
role: PRINCIPAL_INVESTIGATOR
name: Jeffrey C. Noroyan, MD
role: PRINCIPAL_INVESTIGATOR
name: Fredric S. Brandt, MD
role: PRINCIPAL_INVESTIGATOR
name: Robert Dunne, MD
role: PRINCIPAL_INVESTIGATOR
name: Marta Rendon, MD
role: PRINCIPAL_INVESTIGATOR
name: Kimball W Silverton, DO
role: PRINCIPAL_INVESTIGATOR
name: John Tassone, DPM
role: PRINCIPAL_INVESTIGATOR
References: