EUCTR2006-002471-40-DE进行中（未招募）不适用
A 6-week vehicle-controlled, randomized, double-blind, parallel-group multicenter pilot study of the efficacy and safety of Azelaic Acid (AzA) 15% gel in the topical treatment of mild to moderate perioral dermatitis.
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. Male or female patients with a minimum age of 18 years
- •3. Clinical diagnosis of mild to moderate perioral dermatitis
- •4. Investigator’s Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
- •5. 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)
- •6. Willingness and capability to follow all study procedures
- •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. History of atopic dermatitis of the face
- •2. Granulomatous perioral dermatitis
- •3. Facial acne, rosacea, facial demodicosis
- •4. Seborrhoic dermatitis of the nasolabial fold, Lupus erythematosus
- •5. Planned concomitant systemic treatment with antihistamines, analgesic or non-steroidal anti-inflammatory medication
- •6. Start of hormone use (including for birth control) or change of hormone preparations less than 3 months prior to the start of the study or during the study
- •7. Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)
- •8. Planned treatment during the study period with drugs likely to interfere with the diagnosis and the evaluation of efficacy and safety of the study medication
- •9. Patients not observing the required duration of washout
- •10. Pre-treatment with systemic corticosteroids for at least 4 weeks prior to the start of study medication
- •11. Pre-treatment with oral antibiotics (such as doxycycline, tetracycline, erythromycine and minocycline) for at least 4 weeks prior to the start of study medication
- •12. Previous systemic treatment with isotretinoin and isoniazid 6 months prior to the start of study medication
- •13. Previous topical treatment of the face (e.g. antibiotics, calcineurin inhibitors) 2 weeks prior to the start of study medication
- •14. Use of fluorinated toothpaste
- •15. Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study
- •16. Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study
- •17. History of or suspected hypersensitivity to any ingredient of the study drugs
- •18. Suspected unreliability, poor co-operation or non-compliance
- •19. Inability to understand the nature, scope and consequence of the study
- •20. Participation in another clinical study 4 weeks prior to and/or during the conduct of this study
研究者
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