NCT03824912

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

A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) to Ketoconazole Cream 2% (G&W Laboratories Inc.) in the Treatment of Tinea Pedis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 831 (actual)
• Sponsor: Encube Ethicals Pvt. 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 Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) to Ketoconazole Cream 2% (G\&W Laboratories Inc.) in the Treatment of Tinea Pedis

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Ketoconazole Cream 2%	Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
DRUG	Ketoconazole Cream 2% (G&W Laboratories Inc.)	Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
DRUG	Placebo	Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.

Timeline

• Start date: 2018-08-23
• Primary completion: 2019-01-24
• Completion: 2019-01-24
• First posted: 2019-01-31
• Last updated: 2019-06-27
• Results posted: 2019-06-13

Locations

9 sites across 3 countries: United States, Belize, Saint Lucia

Regulatory

• FDA-regulated drug study