Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

Completed · Phase 3 · Has a placebo group

Conditions studied: Tinea Pedis

In brief

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.

Key facts

Study ID

NCT01289015

Run by

Merz North America, Inc.

People needed

855

Starts

2011-02-01

Expected to finish

2012-01-01

Last updated by the study team

2013-09-26

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Associated Foot & Ankle Specialists, LLC — Phoenix, Arizona, United States
• Skin Surgery Medical Group, Inc. — San Diego, California, United States
• UCSF Dermatology Research — San Francisco, California, United States
• The Savin Center, PC — New Haven, Connecticut, United States
• Avail Clinical Research — DeLand, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• Miami Dermatology Research Institute, LLC — North Miami Beach, Florida, United States
• Radiant Research, Inc. — Pinellas Park, Florida, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Physician Skin Care — Louisville, Kentucky, United States
• Michigan Center for Skin Care Research — Clinton Township, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Skin Search of Rochester, Inc. — Rochester, New York, United States
• Crescent Medical Research — Salisbury, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Paddington Testing Co., Inc. — Philadelphia, Pennsylvania, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• DermResearch, Inc. — Austin, Texas, United States
• The Center for Skin Research — Houston, Texas, United States
• Endeavor Clinical Trials, PA — San Antonio, Texas, United States
• Advanced Medical Concepts, PSC — Cidra, PR, Puerto Rico

Full record on ClinicalTrials.gov

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