Clinical trial NCT01290341: Evaluation of the 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: 2011-02-07
Enrollment: 860
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: This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.

Detailed description: This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment.

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.
* For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
* 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: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Encino
country: United States
facility: T. Joseph Raoof, MD, Inc.
state: California
city: San Diego
country: United States
facility: Walter K. Nahm, MD, PhD, Inc.
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Longmont
country: United States
facility: Longmont Clinic, PC
state: Colorado
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Melbourne
country: United States
facility: Lake Washington Foot and Ankle Center
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Minneapolis
country: United States
facility: Department of Veterans Affairs
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Cincinnati
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology & Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Temple University- School of Podiatric Medicine
state: Pennsylvania
city: Simpsonville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, PA
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Lynchburg
country: United States
facility: The Education and Research Foundation, Inc.
state: Virginia
city: Madison
country: United States
facility: Madison Skin and Research, Inc
state: Wisconsin
Study officials:
affiliation: Paddington Testing Co., Inc.
name: Lawrency Parrish, MD
role: PRINCIPAL_INVESTIGATOR
References: