Patients with mild to moderate seborrheic dermatitis of the facial area and meeting the specific eligibility criteria MedDRA version: 8.1 Level: LLT Classification code 10012488 Term: Dermatitis seborrheic
Conditions
Sponsors
Intendis GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following inclusion criteria are eligible for this study: 1. Written informed consent (signed and dated) 2. Willingness and capability to follow all study procedures 3. Male or female patients with a minimum age of 18 years 4. Stable or exacerbating seborrheic dermatis of the face area 5. Investigator’s Global Assessment score at baseline of 2 to 4 (4 ? IGA ? 2) 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are not eligible for this study and are not to be randomized: 1. Pregnancy at baseline 2. Psoriasis (any type and location) 3. Atopic dermatitis 4. Facial acne and rosacea 5. Dermatophytic skin infections 6. Parkinson’s disease 7. Known immunosuppression ; HIV infection 8. Baseline severity score of scaling, erythema (inflammation) and/or itching of = 5 (severe) 9. Requiring continuous systemic or topical corticosteroid or antimycotic therapy 10. Continuous asthma inhalation treatment requiring > 800 mg corticosteroids 11. Not observing the following washout periods prior to study entry 12. Participation in any other investigational drug study in the 4 weeks before study entry 13. Planned treatment during the study period with drugs excluded per protocol 14. Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris) 15. Hypersensitivity to any ingredient of the study drugs 16. Uncontrolled diabetes 17. Suspected unreliability, poor co-operation or non-compliance 18. Inability to understand the nature, scope and consequences of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this double-blind, randomized, controlled, multicenter, parallel-group phase III pilot-study is to show a superiority of AzA 15% gel SH H 655BA over its vehicle („placebo“; SH H 655PBA) in the treatment of patients with mild to moderate seborrheic dermatitis. The study is of explorative nature, the potential efficacy of the AzA 15% gel in seborrheic dermatitis is not known. ;Secondary Objective: -;Primary end point(s): The primary efficacy variables are the sum score of the symptoms of seborrheic dermatitis and as the investigator’s global assessment (IGA). The sum score is derived as the sum of individual scores for scaling, erythema (inflammation), and itching/burning in facial target sites. Patients should present with at least 3 facial target sites preferably forehead/eyebrows; bridge of nose; nasolabial folds. The facial target are graded numerically for erythema, scales and itching/burning. The single symptoms are rated on a 6 point score from 0 to 5. The single scores are added to a total score (= sum score) for all randomized patients and an average, mean, score is then calculated from the total. The investigator’s global assessment (IGA) is a coprimary variable. The IGA provides a subjective overall description/assessment of the acute disease status on a 6-point scale (static score). | — |
Countries
Germany
Outcome results
None listed