A Randomized, Intraindividual, Phase 4 Study to Evaluate the Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects With Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in pruritus NRS on AD lesions
研究概览
简要总结
This study is a randomized, intraindividual study to evaluate the short-term efficacy of triamcinolone acetonide (Aristocort® C) in subjects with atopic dermatitis.
详细描述
This study is being conducted to evaluate the short-term efficacy and effect of triamcinolone acetonide (Aristocort® C) on pruritus, skin biomarkers and skin parameters in subject with atopic dermatitis.
Approximately 20 subjects with atopic dermatitis will receive twice-daily topical application of triamcinolone acetonide (Aristocort® C) or vehicle in two different randomized areas for 3 days.
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 or female subjects 18 years of age or older at the time of consent.
- •Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.
- •Subject has at least a 6-month history of AD and had no significant flares in AD for at least 4 weeks before screening.
- •Subject has 2 applications areas (10 X 10 cm) with a lesional surface of at least 6 X 6 cm, preferably located on 2 distinct anatomical areas at Day 1.
排除标准
- •Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- •Subject has clinically infected AD.
- •Subject has a Fitzpatrick's Skin Phototype ≥
- •Subject has a history of skin disease or presence of skin condition, other than AD, that would interfere with the study assessments in the opinion of the investigator.
- •Subject is known to have immune deficiency or is immunocompromised.
- •Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day
- •Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
- •Subject has a known history of chronic infectious disease.
- •Subject has a known or suspected allergy to triamcinolone acetonide (Aristocort® C) or any component of the investigational product.
研究组 & 干预措施
Triamcinolone Acetonide (Aristocort® C)
干预措施: Triamcinolone Acetonide (Aristocort® C) (Drug)
Vehicle
干预措施: Vehicle (Drug)
结局指标
主要结局
Change from baseline in pruritus NRS on AD lesions
时间窗: 72 hours
The intensity of pruritus will be evaluated using a NRS by asking subjects to assign a numerical score to the worst level of itching at each application area in the past 12 hours, on a scale from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch.
次要结局
- Change from baseline in pruritus NRS on AD lesions(12, 24, 36, 48, and 60 hours)
- Change from baseline in lesion IGA(Day 4)
- Change from baseline in skin biomarkers for AD(Day 2, Day 3, and Day 4)
- Change from baseline in TSS(Day 4)
- Change from baseline in TAA(Day 4)