An investigator-blind, randomized, multicenter, 5-arm, placebo- and active controlled parallel group pilot trial to explore the efficacy and tolerability of topical bifonazole liquid spray in patients with athlete’s foot

• Register: EUCTR
• Last refreshed on: 20 May 2013
• Main ID: EUCTR2008-005654-21-DE
• Date of registration: 13/08/2009
• Prospective Registration: Yes
• Primary sponsor: Bayer Consumer Care AG
• Public title: An investigator-blind, randomized, multicenter, 5-arm, placebo- and active controlled parallel group pilot trial to explore the efficacy and tolerability of topical bifonazole liquid spray in patients with athlete’s foot
• Scientific title: An investigator-blind, randomized, multicenter, 5-arm, placebo- and active controlled parallel group pilot trial to explore the efficacy and tolerability of topical bifonazole liquid spray in patients with athlete’s foot
• Date of first enrolment: 11/09/2009
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005654-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion 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:
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);



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Athlete’s foot, moderate severity.
MedDRA version: 12.0 Level: LLT Classification code 10003621 Term: Athlete's foot

Intervention(s)

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 type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Cutaneous spray*
Route of administration of the placebo: Topical use (Noncurrent)

Trade Name: Lamisil® Once
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: TERBINAFINE
CAS Number: 91161-71-6
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

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.

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.

Secondary Objective: n.a.
This exploratory trial investigates a lot of single and composite efficacy parameters. Therefore, no primary and secondary endpoints are defined.

Secondary ID(s)

13957