Athlete’s foot, moderate severity. MedDRA version: 12.0 Level: LLT Classification code 10003621 Term: Athlete's foot
Conditions
Interventions
Product Name: Bifonazole Liquid Spray
Product Code: BAY H-4502
Pharmaceutical Form: Cutaneous spray*
INN or Proposed INN: Bifonazole
CAS Number: 60628968
Concentration unit: % percent
Concentration ty
Sponsors
Bayer Consumer Care AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet the following eligibility criteria will be enrolled in the trial: 1. Male or female subjects aged between 18 and 70 years; 2. Positive clinical findings of athlete’s foot, limited to interdigital spaces, with a total athlete’s foot severity score (AFSS) of at least 5 and not exceeding 10 points for the signs and symptoms of athlete’s foot, and no sign or symptom scoring 'severe'; 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: Subjects presenting with any of the following will not be included in the trial: 1. Any other dermatological disease, such as psoriasis, which may interfere with the conduct and/or evaluation of the trial; 2. Plantar tinea pedis ("Mocassin-type"); 3. Long-term consequences of diabetes mellitus (i.e. diabetic foot syndrome); 4. Peripheral artery disease; 5. Onychomycosis of any toe; 6. Use of immunosuppressive and/or cytotoxic agents and/or systemic corticosteroids within four weeks prior to screening as well as during the trial 7. Previous treatment with a systemic antifungal within 6 months prior to screening; 8. Previous treatment of feet with a topical antifungal within 4 weeks prior to screening; 9. Previous treatment with a topical antifungal applied to other areas of the body than feet within 2 weeks prior to screening; 10. Previous treatment of any topical medication applied to the feet within 2 11. Topical treatment with potent corticoids (i.e. all corticoids except Hydrocortison) 4 weeks prior to screening as well as during the trial; 12. Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities (according to § 40 (1) 4 AMG);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This explorative pilot trial will assess efficacy and safety of the new bifonazole liquid spray compared to placebo and the active comparator terbinafine film-forming solution (Lamisil Once®). Various endpoints will be assessed in order to select the most appropriate primary endpoint for a confirmatory trial.;Secondary Objective: n.a. This exploratory trial investigates a lot of single and composite efficacy parameters. Therefore, no primary and secondary endpoints are defined.;Primary end point(s): This exploratory trial investigates a set of single and composite efficacy parameters. Therefore, no primary and secondary endpoints are defined. The assessment of these exploratory efficacy variables will allow to identify the most appropriate parameters for the definition of primary and secondary endpoints for a confirmatory study. Exploratory efficacy parameters • Overall cure rate at end of weeks 1 (V4), 2 (V5) and 6 (V7); • Clinical cure rate at end of weeks 1 (V4), 2 (V5) and 6 (V7); • Mycological cure rate at end of weeks 1 (V4), 2 (V5) and 6 (V7); • Rate of negative cultures at end of weeks 1 (V4), 2 (5) and 6 (V7); • Rate of microscopy negative at end of weeks 1 (V4), 2 (V5) and 6 (V7); • Rates of absence of “itching”, and “burning” at each day of the treatment period (Day 2 - Day 6) as reported in the patient diary and V4, V5, V6, and V7; The safety variables are incidence and severity of AEs during the whole trial and vital signs assessed at baseline and at the end of the trial. | — |
Countries
Germany
Outcome results
None listed