dermatomycoses MedDRA version: 20.0 Level: LLT Classification code 10012502 Term: Dermatomycosis, unspecified System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Batrafen® Creme 10 mg/g
Product Name: Batrafen® Creme 10 mg/g
Pharmaceutical Form: Cream
INN or Proposed INN: Ciclopirox olamine
CAS Number: 41621-49-2
Current Sponsor code: n.a.
Other des
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women and men with = 18 years of age • Written informed consent to study participation after verbal and comprehensive information through the investigator • Diagnosis of skin mycosis confirmed by a positive microscopic native preparation in 30 % potassium hydroxide (KOH) • At least moderate severity of skin mycosis, e.g. the severity of the clinical parameters pruritus, burning/stinging, erythema, fissuring/cracking, scaling, and maceration need to sum up to a total score value of = 6 or more, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity). • For women of childbearing potential : Application of an efficient contraceptive method during the whole study • For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start 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 399 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Presence of large-sized and scattered, or deeply embedded skin mycosis which would require systemic treatment with antimycotics • Necessity of application of the study medication in the area around the eyes • Known intolerance or hypersensitivity against ciclopirox olamine or any of the other ingredients in the study medication • Local treatment in the test area during the last 7 days prior study inclusion • Systemic treatment with antimycotics or glucorticoids within the last 4 weeks prior to study inclusion • Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data • Severe acute or chronic concomitant disease with severe impairment of the general condition • Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible • Reasonable doubt concerning the co-operation of the patient • Participation in another clinical study within the last 30 days prior to inclusion in this study • Participation in this study at an earlier date • Women with existing or intended pregnancy or during lactation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes of the score value of the individual clinical symptoms pruritus, burning/stinging, erythema, fissuring/cracking, scaling, and maceration between baseline (Day 0) and week 3 (Day 21 ± 3, EOT) and week 5 (Day 35 ± 5) • Proportion of patients with negative mycological culture at EOT (Day 21 ± 3) and after follow up at week 5 (Day 35 ± 5) • Proportion of patients clinically improved at EOT (Day 21 ± 3) and at week 5 (Day 35 ± 5) to a total score value of not more than 2 and no single parameter with a score value of more than 1 • Evaluation of Overall Therapeutic Success by the investigator and patient at the final examination at week 5 (Day 35 ± 5) ;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficiacy and safety of a new creme containing 10 mg/g Ciclopirox Olamine vs. the originator Batrafen® Cream (Reference) vs. vehicle in patients with skin mycoses;Secondary Objective: see E5 (endpoints);Primary end point(s): Primary efficacy variable to be analysed is the proportion of patients with clinical success at EOT (Day 21 ± 3) defined as a negative mycological culture and a clinically successful treatment defined as total score value (sum of individual scores) of all clinical parameters of not more than 2 and no single parameter with a score value of more than 1 and no further need for antimycotical treatment. ;Timepoint(s) of evaluation of this end point: End of treatment (Day 21 ± 3) | — |
Countries
Germany
Contacts
Public ContactClinical Research Department
Dermapharm AG
Outcome results
None listed