A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).
To evaluate the efficacy and safety of NAFT-500 compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea pedis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
707
topical cream 1 application every day up to 4 weeks weeks
placebo cream 1 application every day for up to 4 weeks
topical allylamine cream applied once a day for up to 4 weeks
Radiant Research
Birmingham, Alabama, United States
Dr. Felix Sigal
Los Angeles, California, United States
Percentage of Subjects With Complete Cure at Week 6.
The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6. The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6. Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale.
Time frame: Week 6
Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6
Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.
Time frame: Week 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
topical placebo cream applied once a day for up to 4 weeks
University of California San Francisco, Dept of Dermatology
San Francisco, California, United States
FXM Research
Miami, Florida, United States
FXM Research
Miramar, Florida, United States
Glazer Dermatology
Buffalo Grove, Illinois, United States
Tulane University Health Services
New Orleans, Louisiana, United States
Silverton Skin Institute
Grand Blanc, Michigan, United States
Zoe Draelos, MD
High Point, North Carolina, United States
Haber Dermatology
Euclid, Ohio, United States
...and 7 more locations