NCT01195831已完成3 期
Multicentre, Randomized, Investigator-Blinded, Parallel-group Study to Assess the Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 244
- 试验地点
- 9
- 主要终点
- Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.
研究概览
简要总结
The purpose of this study is to compare the clinical efficacy of once daily treatment for 4 weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4 weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either gender between 18 and 65 years of age.
- •A clinical diagnosis of scalp psoriasis which is:
- •of an investigator's assessment of clinical signs of the scalp at least ≥ 2 in one of the clinical signs, redness, thickness and scaliness, and at least 1 in each of the other two clinical signs, and total score ≥ 4,
- •of an extent of 10% or more of the total scalp area,
- •of at least moderate severity according the investigator's global assessment.
- •Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
- •The patient must provide signed and dated informed consent before any study related activity is carried out.
排除标准
- •Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- •Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vilgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
- •Any other inflammatory skin diseases that may confound the evaluation of scalp psoriasis
- •Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to visit 1 and during the study.
- •Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to SV2 or during the study.
- •PUVA therapy within 4 weeks prior to randomisation (visit 1) or during the study.
- •UVB therapy wthin 2 weeks prior to randomisation (visit 1) or during the study.
- •Therapies within 2 weeks prior to SV2 and during the study.
- •Topical treatment of psoriasis on non scalp psoriasis lesions with potent or very potent (WHO group III-IV) corticosteroids,
- •Topical treatment of Immunomodulator, e.g. Tacrolimus,
- •Vitamin D analogues (e.g, calcipotriol, tacalcitol, calcitriol),
- •Any topical treatment of the scalp (except for non-steroid medicated shampoos and emollients,
- •Other types of psoriasis treatment, e.g. Chinese medicine, processed Chinese medicine, or hot spring, etc.
- •Planned initiation of, or changes to concomitant medication that could affect scalp psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the study.
- •Known or suspected hypersensitivity to component(s) of the Investigational Products.
- •Known or suspected abnormality of the calcium homeostasis.
- •Known or suspected severe renal insufficiency or severe hepatic disorders, or severe heart disease.
- •Clinical signs or symptoms of Cushing's disease or Addison's disease.
- •Planned extensive exposure to sun (e.g. when working outdoors) during the study, which may affect scalp psoriasis.
- •Females who are pregnant, or of child-bearing potential and wish to become pregnant during the study, or who are breast-feeding.
- •Females of child-bearing potential with a positive serum or urine pregnancy test at SV
- •Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV
- •Participation in any other interventional clinical trial within 4 weeks prior to randomisation.
研究组 & 干预措施
Xamiol® gel
Experimental
Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
干预措施: Xamiol® gel (Drug)
Calcipotriol scalp solution
Active Comparator
Calcipotriol (as hydrate) 50 mcg/ml
干预措施: Calcipotriol scalp solution (Drug)
结局指标
主要结局
Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.
时间窗: 4 weeks
Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.
次要结局
- Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2(2 weeks)
- Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2.(2 weeks)
- Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.(4 weeks)
- Patients With Success (Total Sign Score ≤1) at Week 4(4 weeks)
- For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4(4 weeks)
- Patients With Success (Patient's Itching Score=None) at Week 4(4 weeks)
- Evaluation of the Quality of Life(Baseline to weeks 2 and 4)
研究者
研究点 (9)
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