Trial Outcomes & Findings for Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis (NCT NCT03129321)

Last Updated: 2022-03-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

876 participants

Primary outcome timeframe

Day 42

Results posted on

2022-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	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%	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%	Placebo Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo
Overall Study STARTED	351	350	175
Overall Study COMPLETED	253	241	120
Overall Study NOT COMPLETED	98	109	55

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test n=351 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Reference Standard n=350 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Placebo n=175 Participants Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo	Total n=876 Participants Total of all reporting groups
Age, Continuous	47.3 years STANDARD_DEVIATION 12.9 • n=93 Participants	47.1 years STANDARD_DEVIATION 14.6 • n=4 Participants	46.1 years STANDARD_DEVIATION 13.3 • n=27 Participants	47.0 years STANDARD_DEVIATION 13.7 • n=483 Participants
Sex: Female, Male Female	127 Participants n=93 Participants	114 Participants n=4 Participants	60 Participants n=27 Participants	301 Participants n=483 Participants
Sex: Female, Male Male	224 Participants n=93 Participants	236 Participants n=4 Participants	115 Participants n=27 Participants	575 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	168 Participants n=93 Participants	165 Participants n=4 Participants	81 Participants n=27 Participants	414 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	183 Participants n=93 Participants	185 Participants n=4 Participants	94 Participants n=27 Participants	462 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized White	191 Participants n=93 Participants	197 Participants n=4 Participants	93 Participants n=27 Participants	481 Participants n=483 Participants
Race/Ethnicity, Customized Black/African American	149 Participants n=93 Participants	142 Participants n=4 Participants	74 Participants n=27 Participants	365 Participants n=483 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	9 Participants n=483 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Other	7 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	18 Participants n=483 Participants

PRIMARY outcome

Timeframe: Day 42

Population: Active Treatments of the Per Protocol Population

Outcome measures

Outcome measures
Measure	Test n=185 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Reference Standard n=170 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Placebo Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo
Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure	96 Participants	81 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test n=201 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Reference Standard n=188 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Placebo n=90 Participants Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo
Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure	102 Participants	88 Participants	22 Participants

SECONDARY outcome

Timeframe: Day 42

Population: Active treatment groups of the Per Protocol population

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

Outcome measures

Outcome measures
Measure	Test n=185 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Reference Standard n=170 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Placebo Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo
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	99 Participants	—

SECONDARY outcome

Timeframe: Day 42

Population: Active treatment groups of the Per Protocol population

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

Outcome measures

Outcome measures
Measure	Test n=185 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Reference Standard n=170 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Placebo Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo
Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure	136 Participants	125 Participants	—

SECONDARY outcome

Timeframe: Day 42

Population: Modified Intent to Treat

Outcome measures

Outcome measures
Measure	Test n=214 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Reference Standard n=198 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Placebo n=95 Participants Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days 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)	131 Participants	113 Participants	40 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Test n=201 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Reference Standard n=188 Participants Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Econazole Nitrate Cream, 1%	Placebo n=90 Participants Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Placebo
Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure	147 Participants	137 Participants	37 Participants

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Standard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Abhijit Barve, Head of Global Clinical Research

Mylan Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator shall not publish, or seek to publish, either in whole or in part any results of the study without the written consent of CRO.
Publication restrictions are in place

Restriction type: OTHER