Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 33
- 试验地点
- 8
- 主要终点
- Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
详细描述
TACLONEX ointment has marketing approval in many countries for the treatment of psoriasis vulgaris in adults. No studies have been conducted in patients less than 18 years of age. However, about 25% of affected individuals are diagnosed between 10 and 19 years of age, hence psoriasis is also prevalent in the adolescent age group (12-17 years).
All patients will receive TACLONEX. To evaluate the safety of TACLONEX ointment, all adverse events will be recorded. In addition, any systemic absorption of the active components, betamethasone dipropionate and calcipotriene, will be evaluated by assessing adrenal function (using CORTROSYN™ test) and calcium metabolism (by measuring serum calcium and the urinary calcium:creatinine ratio), respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Aged 12 to 17 years, inclusive.
- •Psoriasis vulgaris on the trunk and/or limbs which is:
- •amenable to topical treatment
- •of an extent of 5-30% of BSA
- •of at least a moderate severity
- •A serum cortisol concentration above 5 mcg/dL before ACTH-challenge and above 18 mcg/dL at 30 minutes after ACTH-challenge.
- •Albumin-corrected serum calcium and urinary calcium:creatinine ratio within the reference range.
排除标准
- •Serious allergy, serious asthma, or serious allergic skin rash.
- •A history of sensitivity to any medication.
- •PUVA or Grenz ray therapy, UVB therapy, systemic treatment with biological therapies, corticosteroids, or other therapies with an effect on psoriasis, topical treatment with corticosteroids or vitamin D analogues, treatment with enzymatic inductors, cytochrome P450 inhibitors, hypoglycemic sulfonamides, antidepressive medications, estrogen therapy, calcium supplements or vitamin D supplements.
- •Guttate, erythrodermic, exfoliative or pustular psoriasis.
- •Viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds.
- •Severe renal insufficiency, severe hepatic disorders, disorders of calcium metabolism associated with hypercalcemia, any cardiac condition or endocrine disorder.
- •Diabetes mellitus
- •Cushing's disease or Addison's disease.
研究组 & 干预措施
TACLONEX ointment
干预措施: Calcipotriene plus betamethasone dipropionate ointment (Drug)
结局指标
主要结局
Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment
时间窗: Week 4
The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment
时间窗: Week 4
The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
时间窗: Baseline and 4 weeks
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
时间窗: Baseline and 4 Weeks
Adverse Drug Reactions
时间窗: Week 4
The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as "not related".
次要结局
- PASI 50 at Week 4.(Week 4)
- "Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at Week 4.(Week 4)
- Percentage Change in PASI From Baseline to Week 4.(Baseline and 4 weeks)
- PASI 75 at Week 4.(4 weeks)
- "Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4.(Week 4)