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

PHASE3CompletedINTERVENTIONAL
Enrollment

831

Participants

Timeline

Start Date

August 23, 2018

Primary Completion Date

January 24, 2019

Study Completion Date

January 24, 2019

Conditions
Tinea Pedis
Interventions
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.

Trial Locations (9)

15241

PEAK Research, LLC, Upper Saint Clair

33014

San Marcus Research Clinic, Inc., Miami Lakes

33027

FXM Research Miramar, Miramar

33144

International Dermatology Research, Inc., Miami

33175

FXM Research Corp., Miami

33609

MOORE Clinical Research, Inc., Tampa

90806

Long Beach Clinical Trial Services, Inc., Long Beach

Unknown

FXM Research International, Belize City

FXM Research International, Castries

All Listed Sponsors
collaborator

Novum Pharmaceutical Research Services

INDUSTRY

collaborator

ACM Global Laboratories

OTHER

lead

Encube Ethicals Pvt. Ltd.

INDUSTRY