Tinea Pedis
Conditions
Keywords
fungal infection, athlete foot
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.
Interventions
DRUGNAFT-600 (naftin 2 % gel)
Topical; applied once daily for two weeks
DRUGPlacebo
Topical; applied once daily for two weeks.
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Cure of Interdigital Tinea Pedis | 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
| Measure | Time frame | Description |
|---|---|---|
| Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Visit 4/ Week 6 | Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively). Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NAFT-600 Topical; applied once daily for two weeks | 572 |
| Placebo Topical; applied once daily for two weeks. | 287 |
| Total | 859 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 21 | 10 |
| Overall Study | Negative baseline culture and others | 44 | 11 |
| Overall Study | Protocol Violation | 7 | 3 |
| Overall Study | Withdrawal by Subject | 19 | 5 |
Baseline characteristics
| Characteristic | Placebo | NAFT-600 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 15 Participants | 19 Participants |
| Age, Categorical >=65 years | 31 Participants | 57 Participants | 88 Participants |
| Age, Categorical Between 18 and 65 years | 252 Participants | 500 Participants | 752 Participants |
| Age Continuous | 45.2 years STANDARD_DEVIATION 14.7 | 45.2 years STANDARD_DEVIATION 14.9 | 45.2 years STANDARD_DEVIATION 14.9 |
| Region of Enrollment United States | 287 participants | 572 participants | 859 participants |
| Sex: Female, Male Female | 73 Participants | 118 Participants | 191 Participants |
| Sex: Female, Male Male | 214 Participants | 454 Participants | 668 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 572 | 5 / 287 |
| serious Total, serious adverse events | 1 / 572 | 2 / 287 |
Outcome results
Primary
Complete Cure of Interdigital Tinea Pedis
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.
Time frame: Visit 4/ Week 6
Population: Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAFT-600 | Complete Cure of Interdigital Tinea Pedis | 26.0 percentage of subjects |
| Placebo | Complete Cure of Interdigital Tinea Pedis | 3.3 percentage of subjects |
Comparison: In order to compare complete cure rate in the NAFT-600 group with that of the Placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively.p-value: <0.025Cochran-Mantel-Haenszel
Secondary
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6
Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively). Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture.
Time frame: Visit 4/ Week 6
Population: Full Analysis Set (FAS) using a Modified Intent to Treat (MITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NAFT-600 | Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Mycological Cure | 58.8 percentage of subjects |
| NAFT-600 | Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Effective Treatment | 50.8 percentage of subjects |
| Placebo | Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Mycological Cure | 10.3 percentage of subjects |
| Placebo | Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Effective Treatment | 7.0 percentage of subjects |