Clinical trial NCT00453271: Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
Official title: A Randomized, Double-Blind, Parallel-Group,Multicenter, Dose-Response, Vehicle-Controlled Study of the Safety and Efficacy of NB-002 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Keywords: chronic persistent infection of the nail bed or plate
Lead sponsor: NanoBio Corporation
Sponsor class: INDUSTRY
First posted: 2007-03-28
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.

Detailed description: The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.

Eligibility criteria: Inclusion Criteria:

* are healthy males or females between the ages of 18 and 75 years of age;
* have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
* positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
* refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
* are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;

Exclusion Criteria:

* females who are pregnant, plan to become pregnant during the study, or are nursing a child;
* are hypersensitive to topical creams, ointments, medications, or surfactants;
* have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
* have taken any investigational drug within 4 weeks prior to the start of the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Planimetry assessment of the target great toenail
timeFrame: Week 24
measure: Rate of complete cure
timeFrame: Week 46
measure: Rate of therapeutic success
timeFrame: Week 46
Secondary outcomes:
measure: Investigator's visual assessment of length of new unaffected nail
measure: The presence/absence of DSO on all toenails
Other outcomes:
Locations:
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Boise
country: United States
facility: Northwest Clinical Trial
state: Idaho
city: Evansville
country: United States
facility: Welborne Clinic
state: Indiana
city: Clinton Township
country: United States
facility: Michigan Center for Research Corp.
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Austin
country: United States
facility: DermResearch Inc.
state: Texas
city: Bryan
country: United States
facility: J & S Studies, Inc.
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, PA
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: St. John's
country: Canada
facility: Newlab Clinical Research, Inc.
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates, LTD
state: Nova Scotia
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research, Inc.
state: Ontario
city: Mississauga
country: Canada
facility: Dermatology Clinic
state: Ontario
city: Oakville
country: Canada
facility: EntraLogix Clinical Group, Inc.
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research, Inc.
state: Quebec
city: Montreal
country: Canada
facility: International Dermatology Research, Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)
Study officials:
affiliation: International Dermatology Research, Inc.
name: Alicia Barba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academic Dermatology Associates
name: Alicia Bucko, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Endeavor Clinical Trials, PA
name: Richard Pollak, DPM, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Derm Research, PLLC
name: Michael Jarratt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: J & S Studies, Inc.
name: Terry Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Welborne Clinic
name: Robert Kaylor, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Clinical Study Center
name: Steven Kempers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Medical Research Center, PC
name: Robert Matheson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Clinical Trial
name: Brock McConnehey,, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Clinical Research, Inc.
name: David Pariser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Dermatology and Research Center
name: Phoebe Rich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Center for Research Corp
name: Dan Stewart, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Research Center, Inc.
name: Leonard Swinyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovaderm Research Inc.
name: Robert Bissonette, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EntraLogix Clinical Group Inc.
name: Sylvia Garnis-Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Dermatology Research, Inc.
name: David Gratton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Guenther Dermatology Research Centre
name: Lyn Guenther, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ultranova Skincare
name: Rod Kunynetz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lynderm Research, Inc.
name: Charles Lynde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Canada Cutaneous Research Associates, LTD
name: Richard Langley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: K. Papp Clinical Research
name: Kim Papp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)
name: Yves Poulin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newlab Clinical Research Inc.
name: Wayne Gulliver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Clinic
name: R G Sibbald, MD
role: PRINCIPAL_INVESTIGATOR
References: