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
855
2 countries
23
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.
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 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
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)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
- 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)
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, 85015, United States
Skin Surgery Medical Group, Inc.
San Diego, California, 92117, United States
UCSF Dermatology Research
San Francisco, California, 94115, United States
The Savin Center, PC
New Haven, Connecticut, 06511, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
International Dermatology Research, Inc.
Miami, Florida, 33144, United States
Miami Dermatology Research Institute, LLC
North Miami Beach, Florida, 33162, United States
Radiant Research, Inc.
Pinellas Park, Florida, 33781, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Physician Skin Care
Louisville, Kentucky, 40217, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432-3133, United States
Skin Search of Rochester, Inc.
Rochester, New York, 14623, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, 19103, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
The Center for Skin Research
Houston, Texas, 77056, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229, United States
Advanced Medical Concepts, PSC
Cidra, PR, 00739, Puerto Rico
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
Lawrence Parish, 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 3, 2011
Study Start
February 1, 2011
Primary Completion
November 1, 2011
Study Completion
January 1, 2012
Last Updated
September 26, 2013
Results First Posted
September 26, 2013
Record last verified: 2013-07