Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 78
- 试验地点
- 17
- 主要终点
- Percentage of Subjects With Adverse Drug Reactions (ADRs)
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of scalp psoriasis which is of an extent of more than or equal to 10% of the scalp area
- •A clinical diagnosis of scalp psoriasis which is of at least moderate severity according to the investigator's global assessment
- •Serum albumin-corrected calcium below the upper reference limit at screening visit 2
排除标准
- •A history of hypersensitivity to any component of the LEO 80185 gel
- •Topical treatment on the trunk and/or limbs with very potent (WHO group IV) corticosteroids within 2 weeks prior to Visit 1 or during the study
- •Topical treatment on the face and/or genital/skin folds with potent or very potent (WHO groups III-IV) corticosteroids within 2 weeks prior to Visit 1 or during the study
- •Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to Visit 1 and during the study:
- •etanercept - within 4 weeks prior to Visit 1
- •adalimumab, alefacept, infliximab - within 2 months prior to Visit 1
- •ustekinumab - within 4 months prior to Visit 1
- •experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1
- •Systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the study
- •UVB therapy within 2 weeks prior to Visit 1 or during the study
- •Any topical treatment on the scalp (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the study
- •Systemic calcium or vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to screening visit 2 or during the study
- •Planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the study
- •Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- •Subjects with any of the following conditions present on the scalp area: viral (e.g., herpes or varicella) lesions of the skin, 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
- •Planned excessive exposure to sun during the study that may affect scalp psoriasis
- •Known or suspected disorders of calcium metabolism associated with hypercalcaemia
研究组 & 干预措施
LEO 80185 gel once daily application
干预措施: LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension) (Drug)
结局指标
主要结局
Percentage of Subjects With Adverse Drug Reactions (ADRs)
时间窗: Throughout trial, up to 8-weeks
Adverse events for which the investigator did not describe the causal relationship to IP as not related
Change in Albumincorrected Serum Calcium From Baseline to Week 4
时间窗: Baseline and week 4
Change in albumincorrected serum calcium from Baseline to week 4
Change in Albumincorrected Serum Calcium From Baseline to Week 8
时间窗: Baseline and week 8
Change in albumincorrected serum calcium from Baseline to week 8
Change in Albumincorrected Serum Calcium From Baseline to End of Treatment
时间窗: Baseline and End of treatment (up to 8 weeks)
Change in albumincorrected serum calcium from Baseline to end of treatment
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
时间窗: Baseline and week 4
Change in 24-hour urinary calcium excretion from Baseline to week 4
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
时间窗: Baseline and week 8
Change in 24-hour urinary calcium excretion from Baseline to week 8
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
时间窗: Baseline and End of treatment (up to 8 weeks)
Change in 24-hour urinary calcium excretion from Baseline to end of treatment
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
时间窗: Baseline and week 4
Change in urinary calcium:creatinine ratio from Baseline to week 4
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8
时间窗: Baseline and week 8
Change in urinary calcium:creatinine ratio from Baseline to week 8
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment
时间窗: Baseline and End of treatment (up to 8 weeks)
Change in urinary calcium:creatinine ratio from Baseline to end of treatment
次要结局
- Change in Plasma PTH From Baseline to Week 4(Baseline and week 4)
- Change in Plasma PTH From Baseline to Week 8(Baseline and week 8)
- Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2(Week 2)
- Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4(Week 4)
- Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8(Week 8)
- Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at End of Treatment(End of treatment (up to 8 weeks))
- Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2(Baseline and week 2)
- Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4(Baseline and week 4)
- Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8(Baseline and week 8)
- Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.(Baseline and End of treatment (up to 8 weeks))
- Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2(Week 2)
- Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4(Week 4)
- Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8(Week 8)
- Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment(End of treatment (up to 8 weeks))
- Withdrawal(Week 4 and 8)