Betamethasone dipropionate; Clotrimazole for Candidiasis of the skin

Inclusion criteria

• {"criterion_text":"- Women and men ≥ 18 years of age\n- Written consent to study participation after thorough information of the patient through the investigator or another medical competent member of the study team\n- Diagnosis of candidiasis of the skin based on clinical symptoms\n- Positive mycological result of a swab revealing at least a moderate number of fungi, microscopically proven\n- Sum score of all clinical parameters (erythema, exudation, dysesthesia/burning, maceration) ≥ 7\n- At least moderate severity of inflammation parameters erythema and exudation (i.e. score value ≥ 2)\n- For women of childbearing potential: Application of an highly effective contraceptive method during the whole study\n- For women of childbearing potential: Pregnancy test with negative result prior to study start"}

Exclusion criteria

• {"criterion_text":"- The treatment area exceeds 10% of the body surface\n- Reasonable doubt concerning the co-operation of the patient\n- Participation in another clinical study within the last 30 days prior to inclusion in this study\n- Participation in this study at an earlier date\n- Women with existing or intended pregnancy or during lactation\n- Topical treatment in the observation area during the last 7 days prior to study inclusion\n- 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\n- Necessity of application of the study medication in the area around the eyes\n- Systemic treatment with antimycotics and/or glucocorticoids within the last 4 weeks prior to study inclusion\n- 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\n- Other severe acute or chronic concomitant disease with severe impairment of the general condition\n- 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\n- Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Treatment success defined as: sum score of clinical parameters ≤ 2 AND all individual score values ≤ 1 AND negative mycological result; assessed at main examination (EOT visit 3 after 14 days)."}

Secondary endpoints

• {"endpoint_text":"- Change of the sum score of clinical parameters between baseline and follow-up visits, and between main examination (EOT) and final examination\n- 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)\n- Evaluation of therapeutic success at visit 2 and EOT by the investigator and by the patient\n- Evaluation of overall therapeutic success by the investigator at the final examination\n- Number (percentage) of patients with clinical relapse/re-infection at the final examination visit","definition_or_measurement_approach":"Secondary endpoints include: change in sum score of clinical parameters between baseline and follow-ups (measured by clinical scoring of erythema, exudation, dysesthesia/burning, maceration); mycological success defined as negative cultivation and/or negative microscopy at visit 3 (EOT) and visit 4 (final); investigator and patient global evaluations at visit 2 and EOT; investigator evaluation at final examination; and occurrence (number/percentage) of clinical relapse/re-infection at final visit."}

Methods

• Recruitment arrangements and informed consent materials (document: K1_ClotriBet-S_RecruitmentInformedConsent) — targeted to patients with skin candidiasis via participating dermatology and related clinics in Germany.
• Flyers (document: K2_ClotriBet-S_RecruitmentMaterial_Flyer) — distribution in participating clinics/dermatology practices to inform potential participants.
• Referral letters (document: K2_ClotriBet-S_RecruitmentMaterial_Referral Letter) — referral of potential participants from other physicians/clinics to participating sites.

Germany

Latest Decision Or Authorization Date

24-02-2025

Number Of Sites

9

Number Of Participants

552

Primary sponsor

Full Name

Dermapharm AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany