Clinical trial NCT01289015: Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
Official title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Pedis
Keywords: fungal infection
athlete foot
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 855
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.


Eligibility criteria: Inclusion Criteria:

* Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
* Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s)).

Exclusion Criteria:

* Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer,unstable angina or myocardial infarction) within the last 6 months.
* Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
* Subjects with a known hypersensitivity to study drugs or their components.
* Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
* Uncontrolled diabetes mellitus.
* Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
* Current diagnosis of immunocompromising conditions.
* Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
* Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.
* Extremely severe tinea pedis (incapacitating).
* Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study

Primary outcomes:
measure: Complete Cure of Interdigital Tinea Pedis
timeFrame: Visit 4/ Week 6
Secondary outcomes:
measure: Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6
timeFrame: Visit 4/ Week 6.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Foot & Ankle Specialists, LLC
state: Arizona
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: UCSF Dermatology Research
state: California
city: New Haven
country: United States
facility: The Savin Center, PC
state: Connecticut
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: N. Miami Beach
country: United States
facility: Miami Dermatology Research Institute, LLC
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Louisville
country: United States
facility: Physician Skin Care
state: Kentucky
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Winston Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Paddington Testing Co., Inc.
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, PA
state: Texas
city: Cidra
country: Puerto Rico
facility: Advanced Medical Concepts, PSC
Study officials:
affiliation: Paddington Testing Co., Inc.
name: Lawrence Parish, MD
role: PRINCIPAL_INVESTIGATOR
References: