A Therapeutic Equivalence Study of Ketoconazole Cream 2%

NCT ID: NCT04203342

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 682 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2020-07-13

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 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.

Conditions

Tinea Pedis

Study Design

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

Study Groups

Ketoconazole 2% cream (Douglas Pharmaceuticals America Ltd.)

Subject will be randomized to either test product/active comparator/placebo comparator. Test product is Ketoconazole 2% cream manufactured by Douglas Pharmaceuticals America Ltd.

Group Type: EXPERIMENTAL

Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.)

Intervention Type: DRUG

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.

Ketoconazole 2% cream (Teva Pharmaceuticals USA)

Subject will be randomized to either test product/active comparator/placebo comparator. Active comparator is Ketaconazole 2% cream manufactured by Teva Pharmaceuticals USA.

Group Type: ACTIVE_COMPARATOR

Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)

Intervention Type: DRUG

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.

Placebo (Douglas Pharmaceuticals America Ltd.)

Subject will be randomized to either test product/active comparator/placebo comparator. Placebo comparator is manufactured by Douglas Pharmaceuticals America Ltd.

Group Type: PLACEBO_COMPARATOR

Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• 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

Douglas Pharmaceuticals America Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Moore Clinical Research

Brandon, Florida, United States

Moore Clinical Reseach

Tampa, Florida, United States

FXM Research International

Belize City, , Belize

Countries

United States; Belize

Other Identifiers

71864602

Identifier Type: -

Identifier Source: org_study_id