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 (part of Sun Pharmaceutical Industries Limited) · 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).
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 548 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
First submitted before Taro Pharmaceuticals USA became part of Sun Pharmaceutical Industries Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
The record gives a start of Jun 2008, a primary completion of Oct 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2009, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Butenafine