moderate to severely inflamed candidiasis of the skin MedDRA version: 20.0 Level: LLT Classification code 10007159 Term: Candidiasis of skin and nails System Organ Class: 100000004862
Conditions
Interventions
Product Name: Miconazole 2%_Fluprednidene 0.1%
Pharmaceutical Form: Cream
INN or Proposed INN: miconazole nitrate
CAS Number: 22832-87-7
Other descriptive name: miconazole nitrate
Concentration unit:
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women and men = 18 years of age • Written consent to study participation after thorough information of the patient through the investigator or another medical competent member of the study team • Diagnosis of candidiasis of the skin based on clinical symptoms • Positive mycological result of a swab revealing at least a moderate number of fungi, microscopically proven • Sum score of all clinical parameters (erythema, exudation, dysesthesia/ burning, maceration) = 7 • At least moderate severity of inflammation parameters erythema and exudation (i.e. score value = 2) • For women of childbearing potential: Application of an highly effective contraceptive method, during the whole study • For women of childbearing potential: 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 330 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 222
Exclusion criteria
Exclusion criteria: • The treatment area exceeds 10% of the body surface • Topical treatment in the treatment area during the last 7 days prior to study inclusion • Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster), lues or tuberculosis of the skin, inoculation reactions, rosacea or rosacea-like dermatitis, perioral dermatitis, acne, primary purulent skin infections (like e.g. folliculitis), atrophied skin, wounds, ulceration • Necessity of application of the study medication in the area around the eyes • Necessity of application of the study medication on mucous membranes • Systemic treatment with antimycotics and/or glucocorticoids within the last 4 weeks prior to study inclusion • Known intolerance or hypersensitivity against miconazole (nitrate) or other imidazole antimycotics, fluprednidene 21-acetate, or any of the other ingredients in the study medications • Other 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 • Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data • 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
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of efficacy and safety of a new cream with miconazole 2 % and fluprednidene 0.1 % in comparison with the approved preparation Vobaderm® Cream and the underlying vehicle in patients with moderately to severely inflamed candidiasis of the skin. See also E5 (endpoints);Secondary Objective: See also E5 (endpoints);Primary end point(s): Number (percentage) of patients with treatment success (defined as sum score of clinical parameters = 2 and all individual score values = 1 and negative mycological result) at the main examination (EOT = visit 3, after 14 days).;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated at the end of treatment (main examination = visit 3, after 14+/- 2 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change of the clinical symptom score between visits, and between EOT and final examination • Number (percentage) of patients with mycological success at EOT and at the final visit • Evaluation of therapeutic success at EOT by the investigator and by the patient • Evaluation of overall therapeutic success by the investigator at the final examination visit • Number (percentage) of patients with clinical relapse / re-infection at the final examination visit ;Timepoint(s) of evaluation of this end point: depending on the endpoint, see E.5.2. | — |
Countries
Czech Republic
Contacts
Public ContactClinical Research Organisation
Proinnovera GmbH
Outcome results
None listed