FindTrial
Sign In

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 Haut English 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

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 Haut English 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004759-39-DE
Enrollment
Unknown
Registered
2007-10-31
Start date
2007-11-26
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Nystaderm comp. Paste Pharmaceutical Form: Cutaneous paste INN or Proposed INN: NYSTATIN CAS Number: 1400619 Concentration unit: IU/g international unit(s)/gram Concentration type: equal C

Sponsors

Dermapharm AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Difference of sum score of the clinical parameters dysesthesia/burning, erythema, pustules/vesicles, exsudation, maceration and extension from first visit (day 0) to main visit (day 3);Primary end point(s): Reduction of inflammation, measured by the sum sore of the parameters dysesthesia/burning, erythema, pustules/vesicles, exsudation, maceration and extension from visit 1 (day 0) to main visit (day 3) ;Secondary Objective: - course of the clinical parameters dysesthesia/burning, erythema, pustules/vesicles, exsudation, maceration and extension individually and as sum score from the first visit (day 0) to the last visit - portion of patients with clinical and mycological successful treatment on day 14 and 21 - portion of patients with just clinical successful treatment on day 14 and 21 - portion of patients with just mycological successful treatment on day 14 and 21 - portion of patients with a relapse - globale evaluation of therapy success by the patient throughout the study course - globale evaluation of therapy success by the investigator throughout the study course—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026