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

NCT03824912 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 71875502
• Study Type: interventional
• Target: 831
• Locations: 3 countries
• Sites: 9

Brief Summary

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

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population)

  Equivalence: Per-Protocol Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis. Therapeutic Failure: A patient will be considered a Therapeutic Failure if: 1. the patient is a Clinical or Mycological Failure 2. the patient was considered to have an insufficient therapeutic response 3. the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study

  Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)

• Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)

  Superiority: modified Intent-to-Treat Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis. Therapeutic Failure: A patient will be considered a Therapeutic Failure if: 1. the patient is a Clinical or Mycological Failure 2. the patient was considered to have an insufficient therapeutic response 3. the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study

  Two weeks after the end of treatment (Day 56 ± 4) (Superiority)

Secondary Outcomes (4)

• Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population)

  Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)

• Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)

  Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)

• Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)

  Two weeks after the end of treatment (Day 56 ± 4) (Superiority)

• Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)

  Two weeks after the end of treatment (Day 56 ± 4) (Superiority)

Study Arms (3)

Test: Ketoconazole Cream 2%

EXPERIMENTAL

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

Drug: Ketoconazole Cream 2%

Reference: Ketoconazole Cream 2%

ACTIVE COMPARATOR

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

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

Placebo: Cream (Test vehicle)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ketoconazole Cream 2% 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.

Test: Ketoconazole Cream 2%

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

Placebo 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or non-pregnant, non-lactating female, ≥ 18 years of age.
• Signed informed consent form (ICF) that meets all criteria of current Food and Drug Administration regulations.
• 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).
• 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.
• 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).
• 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).
• The sum of clinical signs and symptoms scores of the target lesion ≥ 4. See Appendix A for scoring scale:
• Signs: Fissuring/cracking, erythema, maceration and scaling
• 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.

You may not qualify if:

• 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 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 patient'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 patient unsuitable for the study or compromise patient's safety.
• 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.
• Use of antipruritics, including antihistamines, within 72 hours before 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/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.
• 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.

Sponsors & Collaborators

• Encube Ethicals Pvt. Ltd.: lead
• Novum Pharmaceutical Research Services: collaborator
• ACM Global Laboratories: collaborator

Study Sites (9)

Long Beach Clinical Trial Services, Inc.

Long Beach, California, 90806, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

FXM Research Corp.

Miami, Florida, 33175, United States

Location

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

Location

FXM Research Miramar

Miramar, Florida, 33027, United States

Location

MOORE Clinical Research, Inc.

Tampa, Florida, 33609, United States

Location

PEAK Research, LLC

Upper Saint Clair, Pennsylvania, 15241, United States

Location

FXM Research International

Belize City, Belize

Location

FXM Research International

Castries, Saint Lucia

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lalatendu Panigrahi, Chief Scientific Officer
• Organization: Encube Ethicals Pvt Ltd

lalatendu.p@encubeethicals.com

+91-22-6264-7002

Study Officials

• Lalatendu Panigrahi

  Encube Ethicals Pvt. Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study products are blinded and provided to the patients in the same packaging.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: August 23, 2018
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: June 27, 2019
• Results First Posted: June 13, 2019

Record last verified: 2019-06

Locations

SA (1); BE (1); US (7)