A Phase 1 interventional study of Butenafine cream 1% manufactured by Taro and Lotrimin Ultra (butenafine) 1% in Tinea Pedis, sponsored by Taro Pharmaceuticals USA. Completed at 17 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2014-02-04.
Sponsored by Taro Pharmaceuticals USA · Phase 1, Interventional, and Treatment
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
Exclusion Criteria:
Butenafine cream manufactured by Taro applied for 7 days
Drug: Butenafine cream 1% manufactured by Taro
Lotrimin Ultra (butenafine) applied for 7 days
Drug: Lotrimin Ultra (butenafine) 1%
Butenafine vehicle applied for 7 days
Drug: Butenafine Vehicle manufactured by Taro
Treatment applied to affected area twice daily for 7 days
Treatment applied to affected area twice daily for 7 days
Treatment applied to affected area twice daily for 7 days
Therapeutic Cure - Superiority Analysis
Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was \<2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative.
Time frame: 42 days
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
Time frame: 42 days
Therapeutic Cure
Subject with clinical and mycological cure at day 7
Time frame: 7 days
Mycologic Cure
Negative KOH and fungal culture at day 42
Time frame: 42 days
Clinical Cure
The following 8 signs and symptoms are rated at each visit: Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning Each symptom is evaluated using the following scale: 0 = None- Complete absence of any sign or symptom 1. = Mild - obvious but minimal involvement 2. = Moderate - something that is easily noted 3. = Severe - quite marked Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2.
Time frame: 42 days
Safety and Adverse Event Profile
Time frame: 42 days
Patients 12 years of age and older, who presented with interdigital tinea pedis, with a positive potassium hydroxide test (KOH) and met the inclusion/exclusion criteria were enrolled in the trial. Subsequently samples were sent for culture to confirm that either T. rubrum, T. mentagrophytes, or E. floccosum were the causative organism.
| Milestone | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle |
|---|---|---|---|
| Started | 219 | 221 | 108 |
| Positive fungal culture | 149 | 155 | 71 |
| Completed | 143 | 152 | 70 |
| Not completed | 76 | 69 | 38 |
Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was \<2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative.
| Participants | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle |
|---|---|---|---|
| Therapeutic Cure - Superiority Analysis | 76 | 108 | 24 |
Subject with clinical and mycological cure at day 7
| Participants | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle |
|---|---|---|---|
| Therapeutic Cure | 30 | 38 | 11 |
Negative KOH and fungal culture at day 42
| Participants | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle |
|---|---|---|---|
| Mycologic Cure | 101 | 128 | 33 |
The following 8 signs and symptoms are rated at each visit: Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning Each symptom is evaluated using the following scale: 0 = None- Complete absence of any sign or symptom 1. = Mild - obvious but minimal involvement 2. = Moderate - something that is easily noted 3. = Severe - quite marked Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2.
| Participants | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle |
|---|---|---|---|
| Clinical Cure | 83 | 111 | 27 |
Results for this outcome have not been posted.
Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
| Participants | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle |
|---|---|---|---|
| Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra | 63 | 97 | — |
Collected over Adverse event data was collected over the 42 day duration of the study.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Butenafine Cream 1% (Taro) | — | — | — |
| Lotrimin Ultra (Butenafine) 1% | — | — | — |
| Vehicle | — | — | — |
| Event | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle |
|---|---|---|---|
| CellulitisInfections and infestations | 1/219 | 0/221 | 1/108 |
| TachycardiaCardiac disorders | 1/219 | 0/221 | 0/108 |
| Event | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle |
|---|---|---|---|
| HeadacheNervous system disorders | 10/219 | 16/221 | 4/108 |
| NasopharyngitisInfections and infestations | 4/219 | 5/221 | 1/108 |
| Age, Categorical(Participants) | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle | Total |
|---|---|---|---|---|
| <=18 years | 4 | 6 | 2 | 12 |
| Between 18 and 65 years | 135 | 142 | 66 | 343 |
| >=65 years | 10 | 7 | 3 | 20 |
| Sex: Female, Male(Participants) | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle | Total |
|---|---|---|---|---|
| Female | 42 | 41 | 23 | 106 |
| Male | 107 | 114 | 48 | 269 |
| Region of Enrollment(participants) | Butenafine Cream 1% (Taro) | Lotrimin Ultra (Butenafine) 1% | Vehicle | Total |
|---|---|---|---|---|
| United States | 123 | 135 | 62 | 320 |
| Belize | 26 | 20 | 9 | 55 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Taro Pharmaceuticals USA