Opzelura Experience Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Atopic dermatitis is a common multifactorial skin disease. Topicals are the mainstay of treatment, but adherence to topicals is often abysmal, possibly worsened by the complexity of recommended treatment algorithms. Giving patients a simple, one drug approach may be advantageous.
详细描述
Patients' adherence to even one topical treatment is often poor. Even giving patients two treatments reduces treatment adherence compared to one treatment alone. Complicating the treatment with numerous medications along with lifestyle changes may be overwhelming and counterproductive to patients' outcomes. The availability of topical ruxolitinib (Opzelura) provides an opportunity to give patients a highly effective treatment that, unlike standard topical steroids of variable potency, can be used on all areas, even on the face and body folds, and without long-term adverse outcomes. In theory, this offers an opportunity to improve atopic dermatitis (AD) outcomes by simplifying patients' treatment.
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
- Single (Outcomes Assessor)
盲法说明
The investigator assessing the clinical photographs will be blinded to treatment assignment. Participants will know whether they received the Eczema Action Plan
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥2 years of age
- •Patients with a current diagnosis of atopic dermatitis that is mild-to-moderate in severity and in ≥2 body areas
- •Patients with up to 20% total body surface area involvement
- •Women of childbearing age taking/using a contraceptive
排除标准
- •Patients without a current diagnosis of atopic dermatitis
- •Patients who are prescribed changing systemic medications or treatments (phototherapy, biologics) for atopic dermatitis
- •Patients who would require use of other topical medications for other diagnoses (tretinoin, clindamycin)
- •Patients with areas of skin with active infection
- •Patients who are pregnant
研究组 & 干预措施
topical ruxolitinib (Opzelura) and Complex Regimen
patients will be directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed. Patients will also be provided an Eczema Action Plan (EAP) with recommended lifestyle recommendations, including what cleanser to use, allergen avoidance, use of moisturizers, and bathing practices as determined by disease severity.
干预措施: ruxolitinib and an Eczema Action Plan (Drug)
topical ruxolitinib (Opzelura)
patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed.
干预措施: ruxolitinib (Drug)