Tinea Pedis
Conditions
Brief summary
To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1% to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis. To demonstrate the superiority of the Test and Reference (active) treatments over Placebo treatment in patients with tinea pedis. To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.
Interventions
DRUGEconazole Nitrate Cream, 1%
DRUGPlacebo
Sponsors
DPT Laboratories, Ltd.
Mylan Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy male or non-pregnant, non-lactating female ≥ 18 years of age. * Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin). * Provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation * Total score ≥ 4 for the clinical signs and symptoms of tinea pedis in the target area. In addition the target area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or scaling.
Exclusion criteria
* Presence of any other infection of the foot or other disease process that, in the Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis * History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months. * Past history of dermatophyte infections with a lack of response to antifungal therapy * Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface or onychomycosis involving ≥ 20% of the area of either great toenail and/or involving more than five toenails in total or other concurrent dermatophytoses (e.g., tinea cruris) and any other skin disease to an extent that, in the opinion of the investigator, might interfere with the evaluation of tinea pedis or study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure | Day 42 | To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis |
| Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure | Day 42 | To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | Day 42 | The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging |
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | Day 42 | To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum |
| Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | Day 42 | The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging |
| Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure | Day 42 | To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Econazole Nitrate Cream, 1% | 351 |
| Reference Standard Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Econazole Nitrate Cream, 1% | 350 |
| Placebo Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Placebo | 175 |
| Total | 876 |
Baseline characteristics
| Characteristic | Test | Reference Standard | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 47.3 years STANDARD_DEVIATION 12.9 | 47.1 years STANDARD_DEVIATION 14.6 | 46.1 years STANDARD_DEVIATION 13.3 | 47.0 years STANDARD_DEVIATION 13.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 168 Participants | 165 Participants | 81 Participants | 414 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants | 185 Participants | 94 Participants | 462 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 4 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Black/African American | 149 Participants | 142 Participants | 74 Participants | 365 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 6 Participants | 5 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 191 Participants | 197 Participants | 93 Participants | 481 Participants |
| Sex: Female, Male Female | 127 Participants | 114 Participants | 60 Participants | 301 Participants |
| Sex: Female, Male Male | 224 Participants | 236 Participants | 115 Participants | 575 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 351 | 0 / 350 | 0 / 175 |
| serious Total, serious adverse events | 0 / 351 | 0 / 350 | 0 / 175 |
Outcome results
Primary
Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
Time frame: Day 42
Population: Active Treatments of the Per Protocol Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test | Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure | 96 Participants |
| Reference Standard | Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure | 81 Participants |
90% CI: [-5.05, 13.54]
Primary
Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
Time frame: Day 42
Population: Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test | Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure | 102 Participants |
| Reference Standard | Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure | 88 Participants |
| Placebo | Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure | 22 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
p-value: 0.0004Cochran-Mantel-Haenszel
Secondary
Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)
The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging
Time frame: Day 42
Population: Active treatment groups of the Per Protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test | Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | 113 Participants |
| Reference Standard | Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | 99 Participants |
90% CI: [-6.29, 11.98]
Secondary
Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure
To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum
Time frame: Day 42
Population: Active treatment groups of the Per Protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test | Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | 136 Participants |
| Reference Standard | Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | 125 Participants |
90% CI: [-8.29, 8.26]
Secondary
Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)
The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging
Time frame: Day 42
Population: Modified Intent to Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test | Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | 131 Participants |
| Reference Standard | Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | 113 Participants |
| Placebo | Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | 40 Participants |
p-value: 0.002Cochran-Mantel-Haenszel
p-value: 0.0076Cochran-Mantel-Haenszel
Secondary
Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure
To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum
Time frame: Day 42
Population: Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test | Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure | 147 Participants |
| Reference Standard | Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure | 137 Participants |
| Placebo | Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure | 37 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel