NCT04203342

A Therapeutic Equivalence Study of Ketoconazole Cream 2%

A Randomized,Double-blind,Vehicle-controlled, Parallel-design,Multiple-site Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Douglas Pharmaceuticals America Ltd) to Ketoconazole Cream 2% (Teva Pharmaceuticals USA Inc.) in the Treatment of Tinea Pedis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 682 (actual)
• Sponsor: Douglas Pharmaceuticals America Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis.

Detailed description

A randomized, double-blind, vehicle-controlled, parallel-design, multiple-site study to evaluate the clinical (therapeutic) effet of a generic Ketoconazole Cream 2% (Douglas Pharmaceuticals America Ltd) compared with the reference standard Ketoconazole Cream 2% (Teva Pharmaceuticals USA Inc) in subjects with a microbiologically-confirmed, clinical diagnosis of tinea pedis. Approximately 675 subjects, male or female, 18 years or older, will be enrolled.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.)	Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
DRUG	Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)	Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
DRUG	Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)	Topical placebo to treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.

Timeline

• Start date: 2019-12-11
• Primary completion: 2020-05-28
• Completion: 2020-07-13
• First posted: 2019-12-18
• Last updated: 2020-08-06

Locations

3 sites across 2 countries: United States, Belize

Regulatory

• FDA-regulated drug study