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

NCT ID: NCT03824912

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 831 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-23
• Study Completion Date: 2019-01-24

Brief Summary

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

Detailed Description

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

Conditions

Tinea Pedis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test: Ketoconazole Cream 2%

Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)

Group Type: EXPERIMENTAL

Ketoconazole Cream 2%

Intervention Type: 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.

Reference: Ketoconazole Cream 2%

Ketoconazole Cream 2% (G\&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Placebo: Cream (Test vehicle)

Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novum Pharmaceutical Research Services

INDUSTRY

Sponsor Role: collaborator

ACM Global Laboratories

OTHER

Sponsor Role: collaborator

Encube Ethicals Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lalatendu Panigrahi

Role: STUDY_DIRECTOR

Encube Ethicals Pvt. Ltd.

Locations

Long Beach Clinical Trial Services, Inc.

Long Beach, California, United States

International Dermatology Research, Inc.

Miami, Florida, United States

FXM Research Corp.

Miami, Florida, United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

FXM Research Miramar

Miramar, Florida, United States

MOORE Clinical Research, Inc.

Tampa, Florida, United States

PEAK Research, LLC

Upper Saint Clair, Pennsylvania, United States

FXM Research International

Belize City, , Belize

FXM Research International

Castries, , Saint Lucia

Countries

United States; Belize; Saint Lucia

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

71875502

Identifier Type: -

Identifier Source: org_study_id