Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: Ketoconazole Cream 2%; Ketoconazole Cream 2% (G&W Laboratories Inc.); Placebo
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Ketoconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All study products are blinded and provided to the patients in the same packaging.
Enrollment: 831.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or non-pregnant, non-lactating female, ≥ 18 years of age.

          2. Signed informed consent form (ICF) that meets all criteria of current Food and Drug
             Administration regulations.

          3. Female patient of childbearing potential must not be pregnant or lactating at Visit 1
             (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50
             milli-International unit (mIU/mL) or equivalent units of human chorionic
             gonadotropin).

          4. Female patient of childbearing potential must agree to the use of a reliable method of
             contraception throughout the study (e.g., total abstinence, intrauterine device, a
             double-barrier method, oral, transdermal, injected, or implanted non-hormonal or
             hormonal contraceptive) throughout the study. A sterile sexual partner is not
             considered an adequate form of birth control. If the female is using any estrogen or
             oral contraceptive therapy, the same product must have been taken for at least one
             month before Visit 1.

          5. Have clinical diagnosis of tinea pedis with lesions localized to the interdigital
             spaces or predominantly interdigital, but may extend to other areas of the foot (the
             non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea
             pedis moccasin).

          6. The presence of tinea pedis infection provisionally confirmed at baseline by a
             positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from
             the target site are placed on a microscope slide with a drop of 10% KOH, and
             microscopic examination reveals segmented fungal hyphae).

          7. The sum of clinical signs and symptoms scores of the target lesion ≥ 4. See Appendix A
             for scoring scale:

               1. Signs: Fissuring/cracking, erythema, maceration and scaling

               2. Symptoms: pruritus and burning/stinging In addition the target lesion must have a
                  minimum score ≥ 2 for erythema and a minimum score ≥ 2 for either pruritus or
                  scaling.

        Exclusion Criteria:

          1. Females who are pregnant, lactating or planning to become pregnant during the study
             period.

          2. History of or current psoriasis, Lichen planus or contact dermatitis involving the
             feet within the previous 12 months.

          3. History of dermatophyte infections with a lack of response to antifungal therapy
             (recurrent tinea pedis [i.e., more than 3 infections in the past 12 months] that were
             unresponsive to previous antifungal therapy).

          4. History of allergy, hypersensitivity, or intolerance to ketoconazole, other
             imidazoles, sulfites or any other component of the study product.

          5. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.

          6. Current uncontrolled diabetes.

          7. 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 patient's tinea
             pedis.

          8. 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 patient unsuitable for the study or compromise
             patient's safety.

          9. Significant 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 Investigator's
             opinion, would place the patient at undue risk by participating or compromise the
             integrity of the study data.

         10. Use of antipruritics, including antihistamines, within 72 hours before Visit 1.

         11. Use of topical corticosteroids, topical antibiotics or topical antifungal therapy
             (e.g., clotrimazole, econazole, fluconazole) within 2 weeks before Visit 1.

         12. 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/chronic obstructive pulmonary disease maintenance) is
             acceptable to the extent that, in the opinion of the Investigator, does not compromise
             safety of patient or integrity of data.

         13. Use of oral terbinafine or itraconazole within 2 months before Visit 1.

         14. Use of immunosuppressive medication or radiation therapy within 3 months before Visit
             1.

         15. Receipt of any drug as part of a research study within 30 days before Visit 1.

         16. Previous participation in this study.

         17. Employee of the Investigator or research center or their immediate family members.

         18. Inability to understand the requirements of the study and the relative information or
             are unable or unwilling to comply with the study protocol.