Clinical study to compare two creams with the active substance Ciclopirox Olamine and one cream without active substance for patients with skin mycoses
- Conditions
- dermatomycosesMedDRA version: 20.0Level: LLTClassification code 10012502Term: Dermatomycosis, unspecifiedSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-001633-41-DE
- Lead Sponsor
- Dermapharm AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 399
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method 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)<br>• Proportion of patients with negative mycological culture at EOT (Day 21 ± 3) and after follow up at week 5 (Day 35 ± 5)<br>• 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<br>• Evaluation of Overall Therapeutic Success by the investigator and patient at the final examination at week 5 (Day 35 ± 5)<br>;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2