A Therapeutic Equivalence Study of Ketoconazole Cream 2%

NCT04203342 | Completed Phase 3 FDA Drug

• 1 other identifier: 71864602
• Study Type: interventional
• Target: 682
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Tinea Pedis

Keywords

Tinea pedis; Ketoconazole

Outcome Measures

Primary Outcomes (1)

• Therapeutic cure of tinea pedis

  The proportion of subjects in each treatment group with a Therapeutic Cure of tinea pedis at the test-of-cure visit conducted 2 weeks after the end of treatment (Day 56 +/- 4). Therapeutic cure is defined as having both a clinical and mycological cure of tinea pedis.

  2 weeks post-treatment (Day 56)

Secondary Outcomes (2)

• Clinical cure of tinea pedis

  2 weeks post-treatment (Day 56)

• Mycological cure of tinea pedis

  2 weeks post-treatment (Day 56)

Study Arms (3)

Ketoconazole 2% cream (Douglas Pharmaceuticals America Ltd.)

EXPERIMENTAL

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

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

Ketoconazole 2% cream (Teva Pharmaceuticals USA)

ACTIVE COMPARATOR

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

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

Placebo (Douglas Pharmaceuticals America Ltd.)

PLACEBO COMPARATOR

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

Drug: Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)

Interventions

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

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

Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.) 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.

Placebo (Douglas Pharmaceuticals America Ltd.)

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 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.

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 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.

Sponsors & Collaborators

• Douglas Pharmaceuticals America Ltd: lead
• Novum Pharmaceutical Research Services: collaborator
• ACM Global Laboratories: collaborator

Study Sites (3)

Moore Clinical Research

Brandon, Florida, 33511, United States

Location

Moore Clinical Reseach

Tampa, Florida, 33609, United States

Location

FXM Research International

Belize City, Belize

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug will be randomised, packaged and blinded by an independent packaging company.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: December 11, 2019
• Primary Completion: May 28, 2020
• Study Completion: July 13, 2020
• Last Updated: August 6, 2020

Record last verified: 2019-12

Locations

US (2); BE (1)