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

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129321
• Other study ID #: 71532902
• Status: Completed
• Phase: Phase 3
• Start date: March 15, 2016
• Est. completion date: November 17, 2016

Study information

• Verified date: March 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 876
• Est. completion date: November 17, 2016
• Est. primary completion date: November 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Econazole Nitrate Cream, 1%

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	DPT Laboratories, Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 42
Primary	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	Day 42
Secondary	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	Day 42
Secondary	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	Day 42
Secondary	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	Day 42
Secondary	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	Day 42