Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
NAFT-600
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
1 other identifier
interventional
860
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2011
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
September 26, 2013
CompletedSeptember 26, 2013
July 1, 2013
9 months
January 28, 2011
July 26, 2013
July 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Cure of Interdigital Tinea Pedis
The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.
Visit 4/ Week 6
Secondary Outcomes (1)
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6
Visit 4/ Week 6
Study Arms (2)
NAFT-600 ( naftin 2 % gel)
EXPERIMENTALTopical; applied once daily for two weeks
Placebo
PLACEBO COMPARATORTopical; applied once daily for two weeks.
Interventions
Topical; applied once daily for two weeks
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Radiant Research, Inc.
Tucson, Arizona, 85710, United States
T. Joseph Raoof, MD, Inc.
Encino, California, 91436, United States
Walter K. Nahm, MD, PhD, Inc.
San Diego, California, 92123, United States
Colorado Medical Research Center
Denver, Colorado, 80210, United States
Longmont Clinic, PC
Longmont, Colorado, 80501, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Lake Washington Foot and Ankle Center
Melbourne, Florida, 32935, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Hudson Dermatology
Evansville, Indiana, 47714, United States
Department of Veterans Affairs
Minneapolis, Minnesota, 55417, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Radiant Research, Inc
Cincinnati, Ohio, 45249, United States
Radiant Research, Inc.
Columbus, Ohio, 43212, United States
Oregon Dermatology & Research Center
Portland, Oregon, 97210, United States
Temple University- School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107, United States
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, 29681, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
J&S Studies, Inc.
College Station, Texas, 77845, United States
Research Across America
Dallas, Texas, 75234, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
Madison Skin and Research, Inc
Madison, Wisconsin, 53719, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stefan Plaum, MD Associate Medical Director
- Organization
- Merz Pharmaceuticals, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrency Parrish, MD
Paddington Testing Co., Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2011
First Posted
February 7, 2011
Study Start
February 1, 2011
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
September 26, 2013
Results First Posted
September 26, 2013
Record last verified: 2013-07