A Therapeutic Equivalence Study of Ketoconazole Cream 2%
A Therapeutic Equivalence Study of Ketoconazole Cream 2%
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 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.
Inclusion Criteria:

 -  Healthy male or non-pregnant, non-lactating female, 18 years of age or older

 -  Signed ICF meeting all criteria of current FDA regulations

 -  Female subject of childbearing potential must NOT be pregnant or lactating at Visit 1
 (negative urine pregnancy test)

 -  Female subject of childbearing potential must agree to use of reliable method of
 contraception.

 -  Clinical diagnosis of tinea pedis predominantly in interdigital spaces

 -  Tinea pedis confirmed at baseline by positive KOH wet mount.

 -  Sum of clinical signs and symptoms score of target lesion at least 4; in addition
 target lesion must have a minimum score of at least 2 for erythema and a minimum score
 of at least 2 for either pruritis or scaling.

 Exclusion Criteria:

 -  Females who are pregnant, lactating or planning to become pregnant during the study
 period.

 -  history of, or current psoriasis, lichen planus, or contact dermatitis involving the
 feet within the previous 12 months.

 -  history of dermatophyte infections with a lack of response to antifungal systemic or
 topical therapy (recurrent tinea pedis [i.e.more than 3 infections in the past 12
 months] that were unresponsive to previous antifungal therapy).

 -  history of allergy, hypersensitivity, or intolerance to ketoconazole, other
 imidazoles, sulfites or any other component of the study product.

 -  confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.

 -  current uncontrolled diabetes.

 -  presence of any other infection of the foot or other disease process that, in the
 Investigator's opinion, may interfere with the evaluation of the subject's tinea
 pedis.

 -  known history of or current impaired wound healing, presence of peripheral vascular
 disease and/or trophic changes of the lower limbs to an extent that, in the opinion of
 the Investigator would make the subject unsuitable for the study or compromise
 subject's safety.

 -  Signficant history or current evidence of chronic infectious disease, system disorder,
 organ disorder, immunosuppression (due to disease or therapy, including history of
 organ transplant), or other medical condition that, in the opinion of the
 Investigator, would place the subject at undue risk by participating or compromise the
 integrity of the study data.

 -  Use of antipruritics, including antihistamines, within 72 hours prior to Visit 1.

 -  Use of topical corticosteroids, topical antibiotics or topical antifungal therapy
 (e.g. clotrimazole, econazole, fluconazole) within 2 weeks before Visit 1.

 -  Use of systemic (e.g. oral or injectable) antibiotics, systemic antifungal therapy, or
 systemic corticosteroids within 30 days before Visit 1. The use of intranasal, inhaled
 or ophthalmic corticosteroids for acute or chronic conditions (e.g. allergic
 conjunctivitis, asthma/COPD maintenance) is acceptable to the extent that, in the
 opinion of the Investigator, does not compromise safety of subject or integrity of the
 data.

 -  Use of oral terbinafine or itraconazole within 2 months before Visit 1.

 -  Use of immunosuppressive medication or radiation therapy within 3 months before Visit
 1.

 -  Receipt of any drug as part of a research study within 30 days before Visit 1.

 -  Previous participation in this study.

 -  Employee of the Investigator or research centre or their immediate family members.

 -  Inability to understand the requirements of the study and the relative information or
 are unable or unwilling to comply with the study protocol.