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
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Tinea Pedis
- Sponsor
- Merz North America, Inc.
- Enrollment
- 860
- Locations
- 22
- Primary Endpoint
- Complete Cure of Interdigital Tinea Pedis
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.
Detailed Description
This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment.
Investigators
Eligibility Criteria
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.
- •For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
- •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).
Arms & Interventions
Placebo
Topical; applied once daily for two weeks.
Intervention: Placebo
NAFT-600 ( naftin 2 % gel)
Topical; applied once daily for two weeks
Intervention: NAFT-600 (naftin 2 % gel)
Outcomes
Primary Outcomes
Complete Cure of Interdigital Tinea Pedis
Time Frame: Visit 4/ Week 6
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.
Secondary Outcomes
- Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6(Visit 4/ Week 6)