E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate to severely inflamed candidiasis of the skin
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|
E.1.1.1 | Medical condition in easily understood language |
moderate to severely inflamed infection of the skin through yeast fungi |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007159 |
E.1.2 | Term | Candidiasis of skin and nails |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
|
E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | 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). |
|
E.5.2 | 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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
depending on the endpoint, see E.5.2. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 11 |