NCT00882245已完成2 期
A Phase II, Double-Blind, Vehicle Controlled Study to Determine the Efficacy, Safety and Toleration of SRD441 Ointment in Patients With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 主要终点
- Measure efficacy in treating acute exacerbations
研究概览
简要总结
Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 18 or over
- •Subjects with a history of AD
- •Written and dated informed consent
- •Satisfactory medical assessment with no clinical relevant abnormalities.
排除标准
- •Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
- •Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- •Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study.
- •Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.
研究组 & 干预措施
SRD441 Ointment
Experimental
干预措施: Ointment (Drug)
Vehicle ointment
Placebo Comparator
干预措施: Vehicle ointment (Other)
结局指标
主要结局
Measure efficacy in treating acute exacerbations
时间窗: 4 weeks
次要结局
- Safety and local dermal tolerability(4 weeks)
研究者
相似试验
终止
2 期
Safety and Efficacy Study of ImCOOH Cream in Patients Suffering From Moderate Atopic DermatitisAtopic DermatitisNCT00583895Valletta Health B.V.25
Unknown
1 期
Evaluation of A-1 Cool Cream Efficacy for Treatment Atopic DermatitisATOPIC DERMATITISNCT01174511Hadassah Medical Organization30
已完成
2 期
A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin BarrierDermatitis, AtopicNCT03901144ACO Hud Nordic AB50
已完成
4 期
Comparative Study:Topison (Mometasone Furoate) Versus Two Others Mometasone FuroatesAtopic DermatitisNCT04271007Libbs Farmacêutica LTDA32
进行中（未招募）
3 期
Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT06701331AbbVie99