For the treatment of tinea pedis
Conditions
Interventions
Product Name: Ketoconazole 2% cream
Product Code: F126
Pharmaceutical Form: Cream
INN or Proposed INN: Ketoconazole
CAS Number: 65277-42
Sponsors
Janssen Pharmaceutica NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 years or more. 2. Subjects must be co-operative, reliable and sufficiently competent to grade and record symptoms as requested. 3. Clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy. 4. Female subjects must be, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; have a negative urine pregnancy test at screening. 5. Willing to adhere to the prohibitions and restrictions specified in this protocol. 6. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Complicated Tinea pedis defined as: Confluent, diffuse moccasin type tinea pedis of the entire plantar surface, onychomycosis; other dermatomycosis requiring active treatment. 2. Subjects with a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication. 3. History of disallowed therapies: history of oral antifungal treatments within the previous 6 weeks; recent use (within two weeks of the study start) of topical antifungal agent; immunosuppressive or radiation therapy within the previous four weeks; recent use (within two weeks prior to screening) of other oral antibiotics, systemic corticosteroids or topical corticosteroids or antibiotics applied to the feet. 4. Recent history of drug or alcohol abuse, psychosis, or other condition making the subject unlikely to comply with the protocol. 5. Known HIV-positive (testing will not be performed). 6. Uncontrolled diabetes mellitus or peripheral vascular disease requiring active treatment. 7. Clinically relevant abnormal findings on clinical examination of the feet. 8. Any subject in whom skin scraping would be considered contraindicated. 9. Have received an experimental drug or used an experimental medical device within 30 days prior to the study or within five half-lives of the investigational drug, whichever is longer. 10. Is pregnant or breast-feeding. 11. Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether ketoconazole 2% cream (F126) is non-inferior to Nizoral® cream (F012) in effecting mycological cure (MC) following 4 weeks of treatment, following determination of superiority of both active treatment arms to placebo, in the treatment of symptomatic uncomplicated interdigital Tinea pedis. MC is defined as negative Potassium Hydroxide (KOH) microscopy and mycological culture and will be assessed at week 6. ; Secondary Objective: To compare the overall cure (OC) of ketoconazole 2% cream (F126) and Nizoral® cream (F012), versus placebo (F000) at 6 weeks following a 4-week treatment regimen in the treatment of symptomatic uncomplicated interdigital Tinea pedis. Overall cure is defined as MC in addition to a global clinical evaluation of either ‘Completely cleared’ or ‘Marked Improvement’ (assessed at Week 6). To study the safety and tolerability of ketoconazole 2% cream (F126) in this subject population. To determine systemic exposure to ketoconazole following topical application of ketoconazole 2% cream (F126) and Nizoral® cream (F012). ; Primary end point(s): The primary efficacy endpoint is to assess the percentage of patients achieving mycological cure (defined as both KOH microscopy and mycological culture negative) of interdigital Tinea pedis following 4 weeks of treatment. This will be assessed at week 6 (2 weeks after active treatment has stopped). In support of the mycological cure, the clinical efficacy of the therapy will also be assessed. This will be determined by examination of the change in overall score of clinical signs and symptoms and by a global evaluation of the therapy. The change in the overall score of clinical signs and symptoms from baseline measures will be assessed at each visit and at follow-up. | — |
Countries
United Kingdom
Outcome results
None listed