A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris, also known as jock itch.
To evaluate the efficacy and safety of NAFT-500, applied once daily for 2 weeks, compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea cruris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
334
Radiant Research
Birmingham, Alabama, United States
University Clinical Trials
San Diego, California, United States
Percentage of Subjects
Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.
Time frame: Week 4 post-baseline
Mycological Cure and Treatment Effectiveness
Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4.
Time frame: Week 4 (two weeks post-treatment)
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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
Tulane Univeristy Health Services Ctr.
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
Paddington Testing Company
Philadelphia, Pennsylvania, United States
...and 10 more locations