A Randomized, Double-Blind, Intra-Individual, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Different Application Rates of Topically Applied Crisaborole Ointment 2% in Adult Subjects With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Total Signs Score (TSS)
研究概览
简要总结
This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.
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
- •Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to screening and that has been clinically stable for 1 month.
- •Has four application areas of 3 cm in diameter with a TSS of ≥5 and TAA of moderate at Day
- •The application areas must not be located on the face, scalp, axillae, groin, genitals, hands, and feet. The application areas should be ≥1 cm apart.
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 is known to have immune deficiency or is immunocompromised.
- •Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day
- •Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or successfully treated localized carcinoma in situ of the cervix are not to be excluded.
- •Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- •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 (eg, hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
- •Subject with a known lack of efficacy to crisaborole.
- •Subject has a known or suspected allergy to crisaborole, including any non-medicinal ingredient, or component of the container.
- •Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
研究组 & 干预措施
Crisaborole 2% (application rate A, B, C)
Crisaborole (Marketed drug)
干预措施: Crisaborole 2% (Drug)
Placebo ointment (vehicle)
Placebo
干预措施: Placebo ointment (Drug)
结局指标
主要结局
Total Signs Score (TSS)
时间窗: Baseline, Day 15
Change from baseline in TSS in target lesions treated with crisaborole ointment 2% or vehicle at Day 15. Total Signs Score (TSS) of the lesion is the assessment of the severity of erythema, edema/papulation, excoriation, and lichenification. Each of these subscales is scored independently using the 4-point severity scale with a value range from 0 to 3; 0 is the minimum (best) and 3 is the maximum (worst). The total score is computed by the sum of each subscale where the total ranges from the minimum 0 (best) to the maximum 12 (worst).
次要结局
- Total Signs Score (TSS)(Baseline, Day 8, Day 15)
- Target Area Assessment (TAA)(Change from baseline in TAA at Day 8 and Day 15.)