CompletedNCT03129321Updated Mar 7, 2022Results posted

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

A Phase 3 interventional study of Econazole Nitrate Cream, 1% and Placebo in Tinea Pedis, sponsored by Mylan Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-07.

Sponsored by Mylan Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 876
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1% to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis.

To demonstrate the superiority of the Test and Reference (active) treatments over Placebo treatment in patients with tinea pedis.

To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.

Conditions studied

Tinea Pedis

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Healthy male or non-pregnant, non-lactating female ≥ 18 years of age.
Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
Provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation
Total score ≥ 4 for the clinical signs and symptoms of tinea pedis in the target area. In addition the target area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or scaling.

Exclusion criteria

Exclusion Criteria:

Presence of any other infection of the foot or other disease process that, in the Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis
History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
Past history of dermatophyte infections with a lack of response to antifungal therapy
Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface or onychomycosis involving ≥ 20% of the area of either great toenail and/or involving more than five toenails in total or other concurrent dermatophytoses (e.g., tinea cruris) and any other skin disease to an extent that, in the opinion of the investigator, might interfere with the evaluation of tinea pedis or study results

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 876 participants (actual)

Study arms

Experimental
Test
Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Drug: Econazole Nitrate Cream, 1%
Active comparator
Reference Standard
Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Drug: Econazole Nitrate Cream, 1%
Placebo comparator
Placebo
Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
Drug: Placebo

Interventions

DrugEconazole Nitrate Cream, 1%
DrugPlacebo

What researchers measure

Primary outcomes

Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure
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
Time frame: Day 42
Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure
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
Time frame: Day 42

Secondary outcomes

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)
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
Time frame: Day 42
Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure
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
Time frame: Day 42
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)
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
Time frame: Day 42
Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure
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
Time frame: Day 42

Results

Posted Aug 2, 2018

Participant flow

Participant flow — Overall Study
Milestone	Test	Reference Standard	Placebo
Started	351	350	175
Completed	253	241	120
Not completed	98	109	55

Outcome measures

PrimaryProportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure

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

Time frame:: Day 42
Reported as:: Count of participants · Participants

Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure
Participants	Test	Reference Standard
Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure	96	81

Statistical analysis

Test vs Reference Standard · Difference in proportions: 4.24 · 90% CI -5.05 to 13.54

PrimaryProportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure

Time frame:: Day 42
Reported as:: Count of participants · Participants

Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure
Participants	Test	Reference Standard	Placebo
Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure	102	88	22

Statistical analysis

Test vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001
Reference Standard vs Placebo · Cochran-Mantel-Haenszel · p = 0.0004

SecondaryProportion 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)

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

Time frame:: Day 42
Reported as:: Count of participants · Participants

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)
Participants	Test	Reference Standard
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	99

Statistical analysis

Test vs Reference Standard · Difference in proportions: 2.85 · 90% CI -6.29 to 11.98

SecondaryProportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure

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

Time frame:: Day 42
Reported as:: Count of participants · Participants

Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure
Participants	Test	Reference Standard
Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure	136	125

Statistical analysis

Test vs Reference Standard · Difference in proportions: -0.02 · 90% CI -8.29 to 8.26

SecondaryProportion 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)

Time frame:: Day 42
Reported as:: Count of participants · Participants

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)
Participants	Test	Reference Standard	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	113	40

Statistical analysis

Test vs Placebo · Cochran-Mantel-Haenszel · p = 0.0020
Reference Standard vs Placebo · Cochran-Mantel-Haenszel · p = 0.0076

SecondaryProportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure

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

Time frame:: Day 42
Reported as:: Count of participants · Participants

Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure
Participants	Test	Reference Standard	Placebo
Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure	147	137	37

Statistical analysis

Test vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001
Reference Standard vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001

Adverse events

Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Test	—	0/351 (0%)	0/351 (0%)
Reference Standard	—	0/350 (0%)	0/350 (0%)
Placebo	—	0/175 (0%)	0/175 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Test	Reference Standard	Placebo	Total
Mean	47.3 ± 12.9	47.1 ± 14.6	46.1 ± 13.3	47.0 ± 13.7

Sex: Female, Male
Sex: Female, Male(Participants)	Test	Reference Standard	Placebo	Total
Female	127	114	60	301
Male	224	236	115	575

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Test	Reference Standard	Placebo	Total
Hispanic or Latino	168	165	81	414
Not Hispanic or Latino	183	185	94	462
Unknown or Not Reported	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Test	Reference Standard	Placebo	Total
White	191	197	93	481
Black/African American	149	142	74	365
Native Hawaiian or other Pacific Islander	1	0	0	1
Asian	3	4	2	9
American Indian or Alaska Native	0	1	1	2
Other	7	6	5	18

Study locations

No study locations are listed for this record.

Registry details

Key details

Study ID: NCT03129321
Lead sponsor: Mylan Inc.
Collaborators: DPT Laboratories, Ltd.
Responsible party: Sponsor
First posted: Apr 26, 2017
Start date: Mar 15, 2016
Primary completion: Nov 17, 2016
Completion: Nov 17, 2016
Results posted: Aug 2, 2018
Last update: Mar 7, 2022

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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

Study summary

Conditions studied

Browse trials for

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria