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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Mylan Inc.

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    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
  • Proportion of patients in each treatment group who are considered a Mycological Cure [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Mylan Inc.

Dates:
Date Received: April 5, 2017
Date Started: March 15, 2016
Date Completion:
Last Updated: April 21, 2017
Last Verified: April 2017