The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema): A Multicenter Randomized Controlled Trial of Narrowband UVB Versus Optimized Topical Therapy in Patients With Atopic Eczema
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 316
- 试验地点
- 16
- 主要终点
- Percentage of patients that reach EASI50
研究概览
简要总结
The goal of this randomized controlled trial is to study the (cost)effectiveness of NB-UVB phototherapy in patients with atopic eczema/atopic dermatitis.
Half of the participants will undergo a course of NB-UVB phototherapy of 8-16 weeks and apply optimal topical therapy (OTT) for a minimum of 3 months. Researchers will compare the outcomes of this group with the other half of participants that apply OTT only.
详细描述
Atopic eczema (AE) is a chronic fluctuating dermatological disease characterized by a pruritic inflammation of the skin. The condition poses a high global (financial) burden. One of the therapeutic options of AE is phototherapy, with narrowband UVB (NB-UVB) being the most common. The evidence of the (cost-)effectiveness of NB-UVB, however, is scarce and of low quality.
The objective of this pragmatic multicenter single blinded randomized controlled trial is comparing the effectiveness and cost-effectiveness of narrowband ultraviolet B with optimal topical therapy (NB-UVB+OTT) versus OTT at 3 months in adult patients with insufficient control of their AE with standard topical treatment, for whom dermatologist and patient jointly believe that NB-UVB or OTT is needed.
Participants that are randomized into the NB-UVB+OTT group will receive an NB-UVB course (at home or at the outpatient clinic) for at least 8 and up to 16 weeks, combined with OTT for at least 3 months. Participants in the control group (OTT group) will apply OTT for at least 3 months. Visits will occur at baseline and 1-3-6-9-12 months after start. At baseline, patient information is collected including an evaluation of medical history and a physical examination to assess Fitzpatrick skin type and physician-reported clinical signs. During each visit patients are asked to fill out questionnaires. Risks are expected to be as in daily practice.
Primary study parameters/outcome of the study is the percentage of patients with EASI50 (a decrease of the Eczema Area and Severity Index of 50%) at 3 month follow-up. Secondary study parameters/outcome of the study include delta EASI, physician-reported clinical signs, patient-reported symptoms, quality of life, long-term control, cost-effectiveness, side effects at 1-3-6-9-12 months, quantity and potency topical steroid usage, time to starting systemic therapy, patient satisfaction with received treatment, percentage of patients reaching Treatment Target goals and percentage of drop-outs with reasons at 3-6-9-12 months.
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
Single blinded
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
- •Adult (≥18 years of age) patient meeting the UK working party criteria for atopic eczema;
- •AE insufficiently controlled by standard topical care and therefore eligible for NB-UVB or OTT;
- •Investigator Global Assessment (IGA, 0-4) of ≥ 2 (moderate disease);
- •Eczema Area and Severity Index (EASI) of ≥ 7 (moderate disease);
- •Understood and voluntarily signed and dated an informed consent form prior to any study-related procedure or has a legal representative who has, and is willing to comply with the study's requirements.
排除标准
- •Contra-indication for NB-UVB;
- •Genetic defects associated with photosensitivity or skin cancer;
- •Heavily photo-damaged skin;
- •History of multiple (>1) skin malignancies;
- •Use of systemic immunosuppressants/immunomodulators;
- •Use of medication associated with photosensitivity;
- •Patient is already on systemic AE therapy;
- •Patient is already on OTT in the past 2 months;
- •NB-UVB or any systemic therapy in the past 9 months.
研究组 & 干预措施
NB-UVB+OTT
8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy
干预措施: NB-UVB phototherapy (Device)
NB-UVB+OTT
8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy
干预措施: Optimal topical therapy (Combination Product)
Optimal topical therapy (OTT)
(a minimum of) 3 months of optimal topical therapy
干预措施: Optimal topical therapy (Combination Product)
结局指标
主要结局
Percentage of patients that reach EASI50
时间窗: 3 months
Percentage of patients that reach a 50% reduction of the EASI (Eczema Area and Severity Index) at 3 month follow-up
次要结局
- Time to start systemic therapy(1 year)
- Delta EASI(3 months)
- Cost-effectiveness(1 year)
- Patient reported outcomes(1 year)
- Quantity of topical steroid usage(1 year)
- Potency of topical steroid usage(1 year)
研究者
Prof. Dr. Phyllis I. Spuls
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)