Doppelblinde, randomisierte klinische Studie zum Vergleich der Wirksamkeit und Verträglichkeit einer Nystatin (100 000 I.E./g)/Hydrocortisonacetat (5 mg/g) -haltigen Paste vs. einer Nystatin (100 000 I.E./g) -haltigen Paste ohne Hydrocortisonacetat bei Patienten mit mittelschwer bis schwer entzündlicher Candidose der HautEnglish title: Double-blind, randomised clinical study to compare the efficacy and safety of a nystatine (100 000 I.U./g)/hydrocortisone acetate (5 mg/g) -containing paste vs. a nystatine (100 000 I.U./g) -containing paste without hydrocortisone acetate in patients with moderate to severe inflamed candidiasis of the skin - Nystatin/Hydrocortisonacetat-Paste vs. Nystatin-Paste

Conditions: Adult patients with moderate to severe inflamed candidiasis of the skin
MedDRA version: 8.1Level: LLTClassification code 10040809Term: Skin candida NOS

Registration Number: EUCTR2006-004759-39-DE

Lead Sponsor: Dermapharm AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- women and men aged between 18 and 65 years
- written informed consent of patient
- current diagnosis of candidiasis of the skin, proven with a positive mycological smear with at least a moderate amount of candida inside
- parametes erythema and exsudation at least moderate
- clinical parameters dysesthesia/burning, erythema, pustules/vesicles, exsudation, maceration and extension reach a sum score of at least 10
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- topical treatment of the investigation site with antimycotics and/or glucocorticoids less than 7 days prior to study entry
- systemical treatment with antimycotics and/or glucocorticoids less than 4 weeks prior to study entry
- known hypersensitivity to nystatine, hydrocortisone (acetate), zinc oxide or any other ingredients of the study medication
- severe cardiovascular insufficiency, severe liver and renal insufficiency, severe respiratory insufficiency, neoplasm
- severe acute or chronic concomitant disease with strong reduction of general condition
- concomitant diseases which can influence the clinical parameters in a way that an objective assessment is inpossible
- concomitant medication which can influence the methods of measurement or measurement results in a way, that an objective assessment is inpossible
- confirmed doubts towards the cooperation of the patient
- dementia or other intellectual impairment
- history of alcohol and/or drug and/or substance and/or nicotine abuse
-participation in another clinical trial less than 30 days prior to study entry or during this study
- participation in this study before
- female patients: pregnancy or lactation