Trial · NCT00835510

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

NCT00835510, Phase 1, Completed, Sun Pharmaceutical Industries, Inc.; results first posted 2009-10-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis. Trials, record NCT00835510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00835510

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
NCT number: NCT00835510
Status: Completed
Phases: Phase 1
Enrollment: 548 participants, actual
Lead sponsor: Sun Pharmaceutical Industries, Inc.
Conditions: Tinea Pedis
Interventions: Butenafine cream 1% manufactured by Taro, Lotrimin Ultra (butenafine) 1%, Butenafine Vehicle manufactured by Taro
First posted: 2009-02-03
Last updated: 2014-02-04
Results first posted: 2009-10-06

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Therapeutic Cure - Superiority Analysis	42 days	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.
Primary	Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra	42 days	Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
Secondary	Therapeutic Cure	7 days	Subject with clinical and mycological cure at day 7
Secondary	Mycologic Cure	42 days	Negative KOH and fungal culture at day 42
Secondary	Clinical Cure	42 days	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.
Secondary	Safety and Adverse Event Profile	42 days

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Therapeutic Cure - Superiority Analysis	42 days	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.	Participants	NUMBER
SECONDARY	Therapeutic Cure	7 days	ITT Population	Participants	NUMBER
SECONDARY	Mycologic Cure	42 days	ITT population	Participants	NUMBER
SECONDARY	Clinical Cure	42 days	ITT population	Participants	NUMBER
SECONDARY	Safety and Adverse Event Profile	42 days
PRIMARY	Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra	42 days	Patients with negative cultures excluded. Use per protocol population	Participants	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Therapeutic Cure - Superiority Analysis	Butenafine Cream 1% (Taro)	76	Participants
Therapeutic Cure - Superiority Analysis	Lotrimin Ultra (Butenafine) 1%	108	Participants
Therapeutic Cure - Superiority Analysis	Vehicle	24	Participants
Therapeutic Cure	Butenafine Cream 1% (Taro)	30	Participants
Therapeutic Cure	Lotrimin Ultra (Butenafine) 1%	38	Participants
Therapeutic Cure	Vehicle	11	Participants
Mycologic Cure	Butenafine Cream 1% (Taro)	101	Participants
Mycologic Cure	Lotrimin Ultra (Butenafine) 1%	128	Participants
Mycologic Cure	Vehicle	33	Participants
Clinical Cure	Butenafine Cream 1% (Taro)	83	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Butenafine Cream 1% (Taro)	219
Overall Study	STARTED	Lotrimin Ultra (Butenafine) 1%	221
Overall Study	STARTED	Vehicle	108
Overall Study	Positive Fungal Culture	Butenafine Cream 1% (Taro)	149
Overall Study	Positive Fungal Culture	Lotrimin Ultra (Butenafine) 1%	155
Overall Study	Positive Fungal Culture	Vehicle	71
Overall Study	COMPLETED	Butenafine Cream 1% (Taro)	143
Overall Study	COMPLETED	Lotrimin Ultra (Butenafine) 1%	152
Overall Study	COMPLETED	Vehicle	70
Overall Study	NOT COMPLETED	Butenafine Cream 1% (Taro)	76

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Butenafine Cream 1% (Taro)	10	219	10
other	Headache	Nervous system disorders	Lotrimin Ultra (Butenafine) 1%	16	221	16
other	Headache	Nervous system disorders	Vehicle	4	108	4
other	Nasopharyngitis	Infections and infestations	Butenafine Cream 1% (Taro)	4	219	4
other	Nasopharyngitis	Infections and infestations	Lotrimin Ultra (Butenafine) 1%	5	221	5
other	Nasopharyngitis	Infections and infestations	Vehicle	1	108	1
serious	Cellulitis	Infections and infestations	Butenafine Cream 1% (Taro)	1	219	1
serious	Cellulitis	Infections and infestations	Lotrimin Ultra (Butenafine) 1%	0	221	0
serious	Cellulitis	Infections and infestations	Vehicle	1	108	1
serious	Tachycardia	Cardiac disorders	Butenafine Cream 1% (Taro)	1	219	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Butenafine Cream 1% (Taro)
Total, all-cause mortality	Lotrimin Ultra (Butenafine) 1%
Total, all-cause mortality	Vehicle
Total, other adverse events	Butenafine Cream 1% (Taro)	14
Total, other adverse events	Lotrimin Ultra (Butenafine) 1%	21
Total, other adverse events	Vehicle	5
Total, serious adverse events	Butenafine Cream 1% (Taro)	2
Total, serious adverse events	Lotrimin Ultra (Butenafine) 1%	0
Total, serious adverse events	Vehicle	1

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00835510

GET https://conductscience.org/api/trials/v1/NCT00835510/registered

API reference For AI assistants