Skip to content

Evaluation of tolerance and efficacy of preparation TERBINAFIN HBF CREAM (Herbacos-Bofarma) and its comparison with preparation LAMISIL CREAM (Novartis) in patients with interdigital form of tinea pedis.

Evaluation of tolerance and efficacy of preparation TERBINAFIN HBF CREAM (Herbacos-Bofarma) and its comparison with preparation LAMISIL CREAM (Novartis) in patients with interdigital form of tinea pedis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000940-10-CZ
Enrollment
140
Registered
2005-05-13
Start date
2005-07-04
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tinea pedis var. interdigitale

Interventions

Product Name: Terbinafin HBF cream 1% Pharmaceutical Form: Cream INN or Proposed INN: terbinafini hydrochloridum CAS Number: 78628-80-5 Concentration unit: % percent Concentration type: equal Concentr

Sponsors

RE&D VÚFB, s.r.o.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - outpatients (ev. inpatients), both sexes - tinea pedis var. interdigitale - age from 18 to 75 years - signed written informed consent -commitment to respect the treatment regime 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 younger than 18 and older than 75 years - pregnant or nursing women - allergy to cream components in anamnesis - coadministration of cytostatics, immunosupresives and corticoids

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation of tolerance of Terbinafin HBF cream and comparison that of comparator.;Secondary Objective: Evaluation of efficacy of Terbinafin HBF cream and comparison that of comparator.;Primary end point(s): - number of patients clinically cured without ADRs

Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026