EUCTR2006-002060-26-DE进行中（未招募）不适用
A double-blind, randomized, vehicle-controlled, 6-week exploratory multicenter pilot study of the efficacy and safety of Azelaic Acid (AzA) 15% gel in the topical treatment of mild to moderate seborrheic dermatitis of the face -
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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