Clinical study to compare the therapeutic effects of two ointments with the active substances clotrimazole and betamethasone dipropionate and of one ointment 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: 20.0Level: LLTClassification code: 10007159Term: Candidiasis of skin and nails Class: 10021881Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2022-501415-14-00
- Lead Sponsor
- Dermapharm AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 552
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
The treatment area exceeds 10% of the body surface, 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, 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, varicella), 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, suspected additional bacterial infection, Necessity of application of the study medication in the area around the eyes, Systemic treatment with antimycotics and/or glucocorticoids within the last 4 weeks prior to study inclusion, Known intolerance or hypersensitivity against clotrimazole or other imidazole antimycotics, betamethasone dipropionate or other glucocorticoids, 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
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 ointment with clotrimazole (10 mg/g) and betamethasone dipropionate (0.64 mg/g) (Mecloderm®) in comparison with the authorised medicinal product Lotricomb® Ointment and the underlying vehicle of Mecloderm® in patients with moderately to severely inflamed candidiasis of the skin.;Secondary Objective: see 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).
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Change of the sum score of clinical parameters between baseline and follow-up visits, and between main examination (EOT) and final examination;Secondary end point(s):Number (percentage) of patients with mycological success (negative mycological cultivation and/or negative microscopical result) at visit 3 (EOT) and at the final visit (visit 4);Secondary end point(s):Evaluation of therapeutic success at visit 2 and EOT by the investigator and by the patient;Secondary end point(s):Evaluation of overall therapeutic success by the investigator at the final examination;Secondary end point(s):Number (percentage) of patients with clinical relapse/re-infection at the final examination visit