Clinical study to compare the therapeutic effects of two creams with theactive substances miconazole and fluprednidene and of one cream withoutactive substance for patients with moderate to severely inflamed infectionof the skin through yeast fungi

Phase 1

• Conditions: moderate to severely inflamed candidiasis of the skin; MedDRA version: 20.0Level: LLTClassification code 10007159Term: Candidiasis of skin and nailsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-001010-42-CZ
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-12
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 552

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified