Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 599
- 试验地点
- 69
- 主要终点
- Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.
详细描述
Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from labour market. Conventional treatments, including highly potent topical steroids, yield often unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin, a retinoid, in patients who have not responded to avoidance of causative factors, such as contact allergens and skin irritants, non-medicated skin care and highly potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
- •rated as severe by the physician
- •unresponsive to highly potent topical corticosteroids, such as clobetasol
排除标准
- •patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
- •patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
- •patients with psoriasis lesions
- •active fungal, bacterial or viral infections of the hands
- •female patients who are pregnant or breastfeeding
- •female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception
研究组 & 干预措施
Alitretinoin
Patients will receive alitretinoin 30mg capsule for up to 24 weeks
干预措施: alitretinoin (Drug)
Placebo
Patients will receive placebo 30mg capsule for up to 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24
时间窗: Week 24 (end-of-treatment)
The investigator assigned PGA grades according to a 5-point scale (clear \[not detectable\], almost clear \[less than 10% of affected hand surface\], mild disease \[less than 10% of affected hand surface\], moderate disease \[10% to 30% of affected hand surface\], severe disease \[\>30% of affected hand surface\]). PGA ratings were based on an integrated clinical picture of signs, symptoms, and the extent of disease. Symptoms included erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, fissures, and pruritus/pain. The PGA scale ranges from 0 (no symptom) to 4 (severe disease). Participants were considered as responders when they had a PGA of clear or almost clear.
次要结局
- Response Duration for Responding Participants at the End-of-therapy(Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up))
- Percentage Change From Baseline in Extent of Disease at End-of-treatment(Baseline (Week 0) and Week 24 (end-of-treatment))
- Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment(Baseline (Week 0) and Week 24 (end-of-treatment))
- Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment(Week 24 (end-of-treatment))
- Time to Relapse for Responding Participants at the End-of-therapy(Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up))
- Time to Response for Responding Participants at End-of-therapy(Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period(Up to Week 24 (end-of-treatment))
- Number of Participants With Adverse Ophthalmological Change as Assessed by Fundus Photography - Intraocular Pressure(Up to Week 24)
- Number of Participants With Maximum Post Baseline Laboratory Values Outside the Marked Reference Range(Up to Week 28)
- Change From Baseline in Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) Over 24 Weeks(Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24)
- Number of Participants Referred or Not Referred to a Psychiatrist as Per Brief Summary Inventory (BSI) 53 Questionnaire up to 24 Weeks(Up to Week 24)
- Change From Baseline in Patient Health Questionnaire (PHQ-9) Score Over 28 Weeks(Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24, 28)
- Number of Participants Meeting the Referral Criteria of Psychiatric Evaluation Over 28 Weeks(Up to 28 Weeks)
- Change From Baseline in Dizziness Handicap Inventory (DHI) Over 24 Weeks(Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24)
- Number of Participants Responding to Tinnitus Ototoxicity Monitoring Interview (TOMI) Questionnaire Over 24 Weeks(Up to Week 24)
- Percent Change From Baseline in Bone Mineral Density (BMD) by Dual Energy X-ray Absorptiometry (DXA) Over 72 Weeks(Baseline (Week 0) and Week 72)
- Number of Participants With Adverse Audiological Change as Assessed by Puretone Audiogram at Highest Frequency(Up to Week 24)
- Number of Participants With Adequecy of Images Assessed by X-ray Evaluation of Bones(Up to Week 72)