tinea pedis MedDRA version: 9.1 Level: LLT Classification code 10043873 Term: Tinea pedis
Conditions
Interventions
Product Name: MedSpray™ TP 1 %
Pharmaceutical Form: Cutaneous spray, solution
INN or Proposed INN: terbinafine HCl 1%
CAS Number: 0091161-71-6
Current Sponsor code: MedSpray™ TP 1 %
Concentration unit
Sponsors
MedPharm Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 %
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) • Assess recurrence / relapse rate following a single use of MedSpray™ TP 1 % • Assess consumer acceptability of a single use of MedSpray™ TP 1 % ;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. | — |
Countries
Germany
Outcome results
None listed