2024-514548-10-01招募中1 期
Double-blind, randomised clinical study comparing efficacy and safety of Methylprednisolone Aceponate 0.1% Ointment (Test) vs. Advantan® 0.1% Ointment (Reference) vs. Vehicle in patients with mild to moderate atopic dermatitis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 9
- 主要终点
- The primary endpoint of the study is the percent change from baseline (Visit 1) to Visit 4 (EOT) assessed by Eczema Area and Severity Index (EASI)
研究概览
简要总结
Assessment of efficacy and safety of a new methylprednisolone aceponate 0.1% ointment in comparison with the approved preparation Advantan® 0.1% Ointment and the underlying vehicle in patients with mild to moderate atopic dermatitis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Women, men and children/adolescents of ≥ 6 years of age
- •Written consent to study participation after patient information by the investigator
- •In case of patients below the age of 18: Written consent to study participation of legal guardian(s) and child/adolescent patient after an age-appropriate patient- and legal guardian(s)- information session by the investigator
- •Acute flare of atopic dermatitis according to the Investigator´s Global Assessment (IGA score 2 (mild) or 3 (moderate))
- •Affected body surface (BSA) between at least 10% and not more than 40%
- •For women of childbearing potential1: Application of an established highly efficient contraceptive method2 during the whole study
- •For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start
排除标准
- •Any systemic treatment of the atopic dermatitis within the last 4 weeks prior to study inclusion
- •Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
- •Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
- •Reasonable doubt concerning the co-operation of the patient
- •Participation in another clinical study within the last 30 days prior to inclusion in this study
- •Participation in this study at an earlier date
- •Women with existing or intended pregnancy or during lactation
- •Any topical treatment (e.g. topical immunomodulators such as tacrolimus ointment, pimecrolimus cream, topical antibiotics, topical glucocorticoids, other topical anti-inflammatory medication) or physical therapy (e.g. UV radiation) of the atopic dermatitis in the test area 2 weeks prior to study inclusion
- •Presence of tuberculous or syphilitic processes in the treatment area
- •Presence of viral infections (such as herpes or varicella), rosacea, perioral dermatitis, ulcera, acne vulgaris, atrophic skin diseases and vaccination skin reactions in the area to be treated.
- •Presence of bacterial and/or mycotic skin diseases in the treatment area
- •Current diagnosis of glaucoma or cataract
- •Known intolerance or hypersensitivity against methylprednisolone aceponate or any of the other ingredients in the study medication
- •Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area, which would interfere with evaluations
- •Severe acute or chronic concomitant disease with severe impairment of the general condition
结局指标
主要结局
The primary endpoint of the study is the percent change from baseline (Visit 1) to Visit 4 (EOT) assessed by Eczema Area and Severity Index (EASI)
The primary endpoint of the study is the percent change from baseline (Visit 1) to Visit 4 (EOT) assessed by Eczema Area and Severity Index (EASI)
次要结局
- Percent change of Eczema Area and Severity Index (EASI) between visits
- Percent change of the total affected body surface area (BSA) between visits, and between baseline and week 3 (EOT)
- Change of the Investigator’s Global Assessment (IGA) between visits, and between baseline and week 3 (EOT)
- Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT)
- Patient´s assessment of severity of pruritus
研究者
Anje Schmidt
Scientific
Dermapharm AG
研究点 (9)
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