Clinical trial NCT03129321: Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Pedis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: DPT Laboratories, Ltd.
First posted: 2017-04-26
Enrollment: 876
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure
timeFrame: Day 42
measure: Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure
timeFrame: Day 42
Secondary outcomes:
measure: 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)
timeFrame: Day 42
measure: Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure
timeFrame: Day 42
measure: 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)
timeFrame: Day 42
measure: Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure
timeFrame: Day 42
Other outcomes:
Locations:
Study officials:
References: