A phase IIa randomised, observer-blind, comparative study of the efficacy, tolerability and consumer acceptability of topical MedSpray™ TP 1 % versus Lamisil® Once 1 % in the treatment of tinea pedis - Tinea Pedis
- Conditions
- tinea pedisMedDRA version: 9.1Level: LLTClassification code 10043873Term: Tinea pedis
- Registration Number
- EUCTR2008-002399-92-DE
- Lead Sponsor
- MedPharm Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
All of the following criteria have to be met for inclusion of a subject in the study:
• men and women aged 18 years or over;
• presence of interdigital tinea pedis caused by dermatophytes on one or both feet, characterized by physician’s global assessment score of 2 (notable signs and symptoms exist”) or 3 (prominent signs and symptoms exist”) at baseline
• the physical examination must be without other disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of 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
Patients are to be excluded from the study when one or more of the following conditions are met:
• patients aged under 18 years;
• patients with hyperkeratotic chronic plantar tinea pedis (moccasin type);
• patients who are immunosuppressed (includes patients receiving radiation therapy or systemic therapy with cytostatic or immunosuppressive drugs at time of study or within the 2 weeks prior to entry);
• patients who had active treatment in the last 2 weeks before entry, or are currently undergoing active treatment for another dermatomycosis with a drug other than the study drugs;
• patients with diabetes;
• patients with compromised circulation;
• patients who have been treated with oral anti-fungal agents within the 12 weeks prior to study entry or treated with topical anti-fungal agents on the feet within the previous 2 weeks;
• evidence of drug or alcohol abuse;
• pregnancy or nursing;
• symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
• treatment with any other investigational drug in the four weeks preceding the study;
• patients with known hypersensitivity to terbinafine or any of the test or comparator product excipients (see appendix A of study protocoll);
• treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study (e.g. antihistamines or glucocorticosteroids);
• contraindications according to summary of product characteristics of Lamisil® Once or according to IB on MedSprayTM TP 1 %
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of MedSpray™ TP 1 % compared to Lamisil® Once 1 % as determined by the proportion of subjects categorised as successfully treated at week 1, as measured by the physician’s global assessment score for clinical signs and symptoms;Secondary Objective: • Assess tolerability of a single use of MedSpray™ TP 1 % (adverse events)<br>• Assess recurrence / relapse rate following a single use of MedSpray™ TP 1 %<br>• Assess consumer acceptability of a single use of MedSpray™ TP 1 %<br>;Primary end point(s): Treatment success based on the Physician’s global assessment score (see section 6.3 of study protocol) at the week one follow up is the primary variable.<br><br>
- Secondary Outcome Measures
Name Time Method