CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 831 enrolled
Drug / intervention
Ketoconazole Cream 2% +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03824912
NCT03824912Phase 3Completed

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

Encube Ethicals Pvt. Ltd.·interventional·Posted Jan 31, 2019·Updated Jun 27, 2019

In Brief

A Phase 3 clinical trial evaluating Ketoconazole Cream 2%, Ketoconazole Cream 2% (G&W Laboratories Inc.), and 1 other intervention for Tinea Pedis. Completed, enrolled 831 participants across 9 sites in 3 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinea Pedis
CountriesBelize, Saint Lucia, United States

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 31, 2019
Enrollment StartAug 23, 2018
Primary CompletionJan 24, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.4 years ago

Interventions

Ketoconazole Cream 2%drug

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.

Ketoconazole Cream 2% (G&W Laboratories Inc.)drug

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.

Placebodrug

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.