Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis (NCT01289015) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
United States855 participantsStarted 2011-02
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* 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)).
Exclusion Criteria:
* 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 no…