Tinea PedisPhase 3NCT03129321

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

A Phase 3 study testing Econazole Nitrate Cream, 1% in people with Tinea Pedis, run by Mylan Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tinea Pedis
What is being tested?: Econazole Nitrate Cream, 1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 876 participants
Where: No sites listed yet
Study dates: 15 Mar 2016to 17 Nov 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

About this study

Official title: Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Econazole Nitrate Cream, 1% (Renaissance Pharma, Inc.) to Econazole Nitrate Cream, 1% (Perrigo New York Inc.) in Tinea Pedis

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: Tinea Pedis
Being tested: Econazole Nitrate Cream, 1%, Placebo
Medical subject headings: Tinea Pedis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Econazole Nitrate Cream, 1%Drug
PlaceboDrug

Study groups in NCT03129321
Study group	Role	What they receive
Test	Experimental	Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Receives: Drug: Econazole Nitrate Cream, 1%
Reference Standard	Active comparator	Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Receives: Drug: Econazole Nitrate Cream, 1%
Placebo	Placebo comparator	Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Day 42

Secondary outcomes (4)

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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201617 Nov 2016

First posted26 Apr 2017
Study start15 Mar 2016
Primary completion17 Nov 2016
Study completion17 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tinea PedisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 876 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03129321
Sponsor's protocol ID: 71532902
Status last verified: Mar 2022
First submitted: 5 Apr 2017
Last updated: 7 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight

All Tinea Pedis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Econazole Nitrate Cream, 1% (Renaissance Pharma, Inc.) to Econazole Nitrate Cream, 1% (Perrigo New York Inc.) in Tinea Pedis
ClinicalTrials.gov ID: NCT03129321
Acronym / sponsor ID: 71532902
Conditions: Tinea Pedis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 876 participants (actual)
Lead sponsor: Mylan Inc.Industry (pharma, biotech, devices)
Collaborators: DPT Laboratories, Ltd.
Study start: 15 Mar 2016 (actual)
Primary completion: 17 Nov 2016 (actual)
Study completion: 17 Nov 2016 (actual)
First posted: 26 Apr 2017 (actual)
Results: Posted 2 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Econazole Nitrate Cream, 1%	Drug	Reference Standard, Test
Placebo	Drug	Placebo

Primary outcome

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

4 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)
Time frame: Day 42
Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure
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)
Time frame: Day 42
Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure
Time frame: Day 42

Results and safety

Results posted to the registry on 2 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test	351	253
Reference Standard	350	241
Placebo	175	120

Primary outcome: Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure

Time frame: Day 42. Count of participants. Unit: Participants

Measure	Test n = 185	Reference Standard n = 170
Value	96	81

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

Population analysed: Active Treatments of the Per Protocol Population

Primary outcome: Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure

Time frame: Day 42. Count of participants. Unit: Participants

Measure	Test n = 201	Reference Standard n = 188	Placebo n = 90
Value	102	88	22

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

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 351 (0%)	0 of 351 (0%)	Not reported
Reference Standard	0 of 350 (0%)	0 of 350 (0%)	Not reported
Placebo	0 of 175 (0%)	0 of 175 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tinea Pedis

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Econazole Nitrate Cream, 1% in people with Tinea Pedis, run by Mylan Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure (time frame: Day 42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03129321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.