Trial Outcomes & Findings for Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis (NCT NCT00835510)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

548 participants

Primary outcome timeframe

42 days

Results posted on

2014-02-04

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Butenafine Cream 1% (Taro) Butenafine cream manufactured by Taro applied for 7 days	Lotrimin Ultra (Butenafine) 1% Lotrimin Ultra (butenafine) applied for 7 days	Vehicle Butenafine vehicle applied for 7 days
Overall Study STARTED	219	221	108
Overall Study Positive Fungal Culture	149	155	71
Overall Study COMPLETED	143	152	70
Overall Study NOT COMPLETED	76	69	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Butenafine Cream 1% (Taro) n=149 Participants Butenafine cream manufactured by Taro applied for 7 days	Lotrimin Ultra (Butenafine) 1% n=155 Participants Lotrimin Ultra (butenafine) applied for 7 days	Vehicle n=71 Participants Butenafine vehicle applied for 7 days	Total n=375 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	135 Participants n=5 Participants	142 Participants n=7 Participants	66 Participants n=5 Participants	343 Participants n=4 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	41 Participants n=7 Participants	23 Participants n=5 Participants	106 Participants n=4 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	114 Participants n=7 Participants	48 Participants n=5 Participants	269 Participants n=4 Participants
Region of Enrollment United States	123 participants n=5 Participants	135 participants n=7 Participants	62 participants n=5 Participants	320 participants n=4 Participants
Region of Enrollment Belize	26 participants n=5 Participants	20 participants n=7 Participants	9 participants n=5 Participants	55 participants n=4 Participants

PRIMARY outcome

Timeframe: 42 days

Population: Patients with negative cultures at baseline are excluded. Efficacy ITT analysis includes all patients with positive baseline cultures, who received at least one dose of medication, had a follow-up visit and had data for the day 42 visit.

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.

Outcome measures

Outcome measures
Measure	Butenafine Cream 1% (Taro) n=143 Participants Butenafine cream manufactured by Taro applied for 7 days	Lotrimin Ultra (Butenafine) 1% n=152 Participants Lotrimin Ultra (butenafine) applied for 7 days	Vehicle n=70 Participants Butenafine vehicle applied for 7 days
Therapeutic Cure - Superiority Analysis	76 Participants	108 Participants	24 Participants

PRIMARY outcome

Timeframe: 42 days

Population: Patients with negative cultures excluded. Use per protocol population

Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).

Outcome measures

Outcome measures
Measure	Butenafine Cream 1% (Taro) n=126 Participants Butenafine cream manufactured by Taro applied for 7 days	Lotrimin Ultra (Butenafine) 1% n=139 Participants Lotrimin Ultra (butenafine) applied for 7 days	Vehicle Butenafine vehicle applied for 7 days
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra	63 Participants	97 Participants	—

SECONDARY outcome

Timeframe: 7 days

Population: ITT Population

Subject with clinical and mycological cure at day 7

Outcome measures

Outcome measures
Measure	Butenafine Cream 1% (Taro) n=149 Participants Butenafine cream manufactured by Taro applied for 7 days	Lotrimin Ultra (Butenafine) 1% n=153 Participants Lotrimin Ultra (butenafine) applied for 7 days	Vehicle n=71 Participants Butenafine vehicle applied for 7 days
Therapeutic Cure	30 Participants	38 Participants	11 Participants

SECONDARY outcome

Timeframe: 42 days

Population: ITT population

Negative KOH and fungal culture at day 42

Outcome measures

Outcome measures
Measure	Butenafine Cream 1% (Taro) n=141 Participants Butenafine cream manufactured by Taro applied for 7 days	Lotrimin Ultra (Butenafine) 1% n=152 Participants Lotrimin Ultra (butenafine) applied for 7 days	Vehicle n=70 Participants Butenafine vehicle applied for 7 days
Mycologic Cure	101 Participants	128 Participants	33 Participants

SECONDARY outcome

Timeframe: 42 days

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	Butenafine Cream 1% (Taro) n=142 Participants Butenafine cream manufactured by Taro applied for 7 days	Lotrimin Ultra (Butenafine) 1% n=152 Participants Lotrimin Ultra (butenafine) applied for 7 days	Vehicle n=70 Participants Butenafine vehicle applied for 7 days
Clinical Cure	83 Participants	111 Participants	27 Participants

SECONDARY outcome

Timeframe: 42 days

Outcome measures

Outcome data not reported

Adverse Events

Butenafine Cream 1% (Taro)

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Lotrimin Ultra (Butenafine) 1%

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Butenafine Cream 1% (Taro) Butenafine cream manufactured by Taro applied for 7 days	Lotrimin Ultra (Butenafine) 1% Lotrimin Ultra (butenafine) applied for 7 days	Vehicle Butenafine vehicle applied for 7 days
Infections and infestations Cellulitis	0.46% 1/219 • Number of events 1 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.	0.00% 0/221 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.	0.93% 1/108 • Number of events 1 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.
Cardiac disorders Tachycardia	0.46% 1/219 • Number of events 1 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.	0.00% 0/221 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.	0.00% 0/108 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.

Other adverse events

Other adverse events
Measure	Butenafine Cream 1% (Taro) Butenafine cream manufactured by Taro applied for 7 days	Lotrimin Ultra (Butenafine) 1% Lotrimin Ultra (butenafine) applied for 7 days	Vehicle Butenafine vehicle applied for 7 days
Nervous system disorders Headache	4.6% 10/219 • Number of events 10 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.	7.2% 16/221 • Number of events 16 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.	3.7% 4/108 • Number of events 4 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.
Infections and infestations Nasopharyngitis	1.8% 4/219 • Number of events 4 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.	2.3% 5/221 • Number of events 5 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.	0.93% 1/108 • Number of events 1 • Adverse event data was collected over the 42 day duration of the study. The Safety Population includes all 548 patients who received at least a single dose of medication.

Additional Information

Medical Director

Taro Pharmaceuticals

Phone: (914) 345-9001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60