Comparison of Fumaric Acid Ester-PUVA (FAE-PUVA) Versus Acitretin-PUVA (Re-PUVA) in Pustular Palmoplantar Psoriasis,a Prospective, Randomized, Controlled, Single-blinded Study
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Duration of remission
研究概览
简要总结
The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of oral photochemotherapy (PUVA) combined with acitretin versus oral PUVA combined with systemic fumaric acid esters (FAE) in patients with pustular palmoplantar psoriasis.
Patients will be randomized and allocated in concealed manner to one of the two treatment arms: acitretin-PUVA or FAE-PUVA.
详细描述
Acitretin-PUVA treatment schedule:
Acitretin monotherapy: Patients randomized to the acitretin group will receive acitretin in a dose of 1mg /kg daily two weeks prior to additional PUVA treatment.
Acitretin-PUVA combination: PUVA treatment (see below) will be applied thrice weekly in addition to acitretin until (near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is defined by improvement of the clinical baseline score (see below) by ≥90%.
Acitretin maintenance therapy: After (near) complete clearance patients will be continued on a maintenance dose of 0.5 mg/kg acitretin over 6 months or until significant relapse. Significant relapse is defined by a worsening of the clinical score to ≥50 % of the baseline score.
Follow-up period: Patients who are still significantly improved (clinical score of <50% of the baseline score) will be followed up until significant relapse or over a maximum period of 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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pustular palmoplantar psoriasis
- •Patients older than 18 years
排除标准
- •Pregnant and lactating women
- •Uncontrolled hyperlipidemia
- •Patients with severely impaired hepatic function
- •Patients with severely impaired renal function
- •Immunosuppression.
- •Abnormal UVA sensitivity
- •Intake of photosensitizing drugs
- •Oral antipsoriatic therapy within the last 4 weeks
- •Topical antipsoriatic therapy within the last 2 weeks
结局指标
主要结局
Duration of remission
时间窗: 12 month
次要结局
- Secondary outcome measures: Percentage of patients achieving remission Number of PUVA exposures required for inducing remission Total UVA exposure dose required for inducing remission Frequency and quality of adverse reactions(15.5 month)