An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot

A Double-Blind, Randomized, Parallel Group Comparison of Nizoral Cream (F012), Ketoconazole 2% Cream (F126) and Placebo (F000) in the Treatment of Interdigital Tinea Pedis

The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo in treating patients with Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus.

Study Overview

• Status: Terminated
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Ketoconazole 2% cream (formulation F126); Drug: Ketoconazole 2% cream (formulation F012) (Nizoral); Drug: Placebo cream

Detailed Description

This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned treatment), multicentre study in Poland and the United Kingdom designed to assess the mycological (fungal) cure rate and clinical efficacy of a new formulation of ketoconazole 2% cream (F126) with the current formulation of ketoconazole 2% cream (Nizoral) (F012) compared with placebo cream in patients with symptomatic uncomplicated interdigital (between the toes) Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus. Approximately 548 patients who have symptomatic uncomplicated interdigital Tinea pedis confirmed by positive potassium hydroxide (KOH) microscopy (examination using a microscope) and mycological (fungal) culture will be randomized to receive 1 of 2 formulations of ketoconazole 2% cream (formulation F012 or F126) or placebo cream. There will be 4 study visits during the study. At Visit 1 (baseline), patients will sign the informed consent and be assessed for mycological and clinical signs and symptoms of Tinea pedis. Baseline demographics (age, race, etc), medical history and medication (s) that the patient is currently taking will be recorded. Patients will be issued with a tube of the cream and instructed to apply the cream sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks according to protocol-specified guidelines. During the 4-week treatment period patients will return to the study every 2 weeks to be assessed for clinical signs and symptoms. After the 4-week treatment period, patients will continue participation in the study for an additional 2 weeks without medication. Patients will return then return to the study center for a final visit (Visit 4, Week 6) at which time skin scrapings will be sampled from interdigital spaces on both feet for KOH microscopy and mycological culture. The primary efficacy endpoint is to determine whether a new formulation of ketoconazole 2% cream is equivalent (or as effective) as the current formulation of ketoconazole 2% cream (Nizoral) compared to a placebo cream in achieving a mycological cure (defined as negative KOH microscopy and negative mycological culture) following 4 weeks of treatment. The primary outcome measure in the study is a mycological cure (defined as negative KOH microscopy and negative mycological culture) at week 6. Patients will be monitored for safety (occurrence of adverse events, use of concomitant medications, and reasons for premature discontinuation from the study) from Visit 1 through Visit 4 (Week 6 or time of early termination from study). Patients will be provided with up to two 15g tubes of ketoconazole cream (formulation F126 or F012) or matching placebo cream and be instructed to apply cream sparingly to affected areas of the feet once daily at night or in the evening for 4 weeks according to protocol specified guidelines.

• Study Type: Interventional
• Enrollment (Actual): 583
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland
  • Lodz, Poland
  • Lublin, Poland
  • Torun, Poland
• United Kingdom
  • Cardiff, United Kingdom
  • Chorley, United Kingdom
  • Glasgow, United Kingdom
  • Liverpool, United Kingdom
  • Manchester, United Kingdom
  • Reading, United Kingdom
  • Sunbury On Thames, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be co-operative, reliable and sufficiently competent to grade and record symptoms as requested
• have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy
• Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study and have a negative urine pregnancy test at screening (applies to women only)
• Sign an informed consent form indicating an understanding of the purpose of and procedures required for the study and willingness to participate in the study

Exclusion Criteria:

• Have complicated Tinea pedis defined as confluent, diffuse moccasin type tinea pedis of the entire plantar surface (undersurface of foot), onychomycosis (fungal nail infection)
• other dermatomycosis (fungal skin infection) requiring active treatment
• Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication
• Have a history of disallowed therapies including oral (by mouth) antifungal treatments within the previous 6 weeks, recent use (within 2 weeks of the study start) of topical antifungal agent, immunosuppressive or radiation therapy within the previous 4 weeks, recent use (within 2 weeks prior to screening) of other oral antibiotics, systemic corticosteroids or topical corticosteroids or antibiotics applied to the feet
• Be HIV-positive (testing will not be performed)
• Have uncontrolled diabetes mellitus or peripheral vascular disease requiring active treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketoconazole 2% cream (formulation F126); ketoconazole 2% cream (formulation F126) A topical white homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.	Drug: Ketoconazole 2% cream (formulation F126); A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.
Experimental: Ketoconazole 2% cream (formulation F012) (Nizoral); ketoconazole 2% cream (formulation F012) (Nizoral) A topical white homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.	Drug: Ketoconazole 2% cream (formulation F012) (Nizoral); A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.
Placebo Comparator: Placebo cream; Placebo cream A topical white homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.	Drug: Placebo cream; A topical, white, homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6	Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6	Overall Cure (OC) was defined as Mycological Cure (MC) in addition to a global clinical evaluation of either 'Completely Cleared' (clearance of all signs and symptoms of Tinea pedis) or 'Marked Improvement' (significant improvement of signs and symptoms of Tinea pedis; residual signs and symptoms only), assessed at Week 6.	Week 6

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: April 22, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimate): April 26, 2010

Study Record Updates

• Last Update Posted (Estimate): April 29, 2014
• Last Update Submitted That Met QC Criteria: April 10, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Tinea Pedis; Antifungal Agents; Ketoconazole (NIZORAL); Miconazole (DAKTARIN)
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: CR012910; KETFUN3001 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)