Clinical study to compare the therapeutic effects of two creams with the active substances miconazole and fluprednidene and of one cream without active substance for patients with moderate to severely inflamed infection of the skin through yeast fungi.
- Conditions
- moderate to severely inflamed candidiasis of the skinMedDRA version: 19.0Level: LLTClassification code 10007159Term: Candidiasis of skin and nailsSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-005707-92-DE
- Lead Sponsor
- Dermapharm AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 340
• Women and men = 18 years of age
• Written consent to study participation after patient information by the investigator
• 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 efficient 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• The treatment area exceeds 10% of the body surface
• Topical treatment in the observation 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>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 (final visit = test-of-cure visit).;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated at the regular study end, i.e. 7 days after end of treatment (= test-of-cure visit).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Change of the clinical symptom score between visits, and between EOT and final examination<br>• Number (percentage) of patients with mycological success at EOT and at the final visit<br>• Evaluation of therapeutic success at EOT by the investigator and by the patient<br>• Evaluation of overall therapeutic success by the investigator at the final examination visit<br>• Number (percentage) of patients with clinical relapse / re-infection at the final examination visit<br>• Number and classification of adverse events<br>• Evaluation of tolerability by the investigator and by the patient at all visits under treatment;Timepoint(s) of evaluation of this end point: Different, depending on the endpoint, see E.5.2.