A Therapeutic Equivalence Study of Ketoconazole Cream 2%

PHASE3CompletedINTERVENTIONAL
Enrollment

682

Participants

Timeline

Start Date

December 11, 2019

Primary Completion Date

May 28, 2020

Study Completion Date

July 13, 2020

Conditions
Tinea Pedis
Interventions
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.

Trial Locations (3)

33511

Moore Clinical Research, Brandon

33609

Moore Clinical Reseach, Tampa

Unknown

FXM Research International, Belize City

All Listed Sponsors
collaborator

Novum Pharmaceutical Research Services

INDUSTRY

collaborator

ACM Global Laboratories

OTHER

lead

Douglas Pharmaceuticals America Ltd

INDUSTRY