NCT02533973已完成4 期
Long-term Treatment of Scalp Psoriasis With Xamiol® Gel in a Large Adult Chinese Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 951
- 试验地点
- 1
- 主要终点
- safety of Xamiol® gel (adverse events)
研究概览
简要总结
A phase 4 trial comparing the safety and efficacy of treatment with Xamiol® gel (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) once daily (as required) with Daivonex® scalp solution (calcipotriol 50 mcg/g) twice daily (as required) in Chinese subjects 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent has been obtained.
- •Subjects of either gender 18 years of age or above.
- •At visit 1, a clinical diagnosis of scalp psoriasis which is:
- •of an investigator's assessment of clinical signs of the scalp of 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 mild severity according the investigator's global assessment
- •Clinical signs of psoriasis vulgaris on trunk and/or limbs, or subject earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
- •Female of childbearing potential using a reliable method of contraception for at least 1 month before the trial start and during the course of the trial (e.g., oral contraceptive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) or females of non-childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy, or tubal section/ligation).
排除标准
- •Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis.
- •Subjects 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 vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers, and wounds.
- •Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation and during the trial:
- •etanercept (Yisaipu) - within 4 weeks prior to randomisation
- •infliximab (Remicade) - within 2 months prior to randomisation
- •other products: within 4 weeks/5 half-lives (whichever is longer) prior to randomisation
- •Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressant's, TCM [(traditional Chinese Medicine)]) within 4 weeks prior to randomisation or during the trial.
- •PUVA therapy within 4 weeks prior to randomisation or during the trial.
- •UVB therapy within 2 weeks prior to randomisation or during the trial.
- •Therapies within 2 weeks prior to randomisation and during the trial:
- •Topical treatment of body psoriasis with very potent (WHO group IV) corticosteroids
- •Topical treatment of face psoriasis with potent or very potent (WHO group III and IV) corticosteroids
- •Any topical treatment of the scalp (except for non-steroid medicated shampoos and emollients)
- •Known or suspected renal insufficiency or hepatic disorders or severe heart disease.
- •Clinical signs or symptoms of Cushing's disease or Addison's disease.
- •Known or suspected hypersensitivity to component(s) of IMPs
- •Current participation in any other interventional clinical trial
- •Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
- •Previously participated in a clinical trial within 4 weeks prior to randomisation.
- •In the opinion of the (sub) investigator, the subject is unlikely to comply with the clinical trial protocol (e.g. due to alcoholism, drug addiction or psychotic state).
- •Females who are pregnant, or of child-bearing potential and wish to become pregnant during the trial, or who are breast-feeding.
- •Females of child-bearing potential with a positive urine pregnancy test at visit 1.
研究组 & 干预措施
Xamiol® gel
Active Comparator
calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as diproprionate) once daily as required, for up to 28 weeks
干预措施: Xamiol® gel (Drug)
. Daivonex® scalp solution
Active Comparator
calcipotriol 50mcg/g twice daily as required, for up to 28 weeks
干预措施: Daivonex® scalp solution (Drug)
结局指标
主要结局
safety of Xamiol® gel (adverse events)
时间窗: 28 Weeks
To establish the safety of Xamiol® gel over a long period for up to 28 weeks of treatment in Chinese subjects. Incidence of adverse drug reactions of any type and Incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.
次要结局
- Efficacy of Xamiol® gel ( percentage of visits in which subjects had "Treatment success" according to Investigator's Global Assessment)(28 Weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)Scalp PsoriasisNCT01052467LEO Pharma724
已完成
不适用
Xamiol®Gel in BODY Psoriasis: A One-year Non-interventional StudyPsoriasis VulgarisNCT02636101LEO Pharma603
已完成
3 期
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp PsoriasisPsoriasis of ScalpNCT00216879LEO Pharma800
已完成
2 期
Determination of the Efficacy and Safety of Psirelax in the Relief of the Disease in PsoriasisMild to Moderate PsoriasisNCT01000714Etwal Ltd.
进行中（未招募）
不适用
ong-term treatment of Scalp Psoriasis with Calciptriol plus Betamethasone dipropionate gel.A phase III safety study of a new gel containing calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as dipropionate) used once daily, as needed, in scalp psoriasis.Psoriasis of the scalpExtent: Minimum 10% of the total scalp areaDisease severity: Graded as moderate, severe, or very severe according to the investigator's global assessment of disease severityClinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbsMedDRA version: 7.0Level: LLTClassification code 10037115EUCTR2004-002861-19-GBEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)800