EUCTR2015-000839-33-PL进行中（未招募）1 期
Safety and Effect of LEO 90100 aerosol foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) with Plaque Psoriasis A phase 2 trial evaluating the safety and efficacy of once daily topical treatment with LEO 90100 aerosol foam in adolescent subjects with plaque psoriasisAn international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis
EO Pharma A/S0 个研究点目标入组 100 人开始时间: 2015年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adolescent subjects (age 12 to 16 years, 11 months).
- •Plaque psoriasis on trunk and/or limbs affecting at least 2% BSA.
- •Plaque psoriasis on the scalp affecting at least 10% of total scalp area.
- •A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA.
- •PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1.
- •PGA score of at least mild on scalp at SV1, SV2 and V1.
- •A serum albumin-corrected calcium below the upper reference limit at SV2.
- •Female subjects must be of either
- •non-childbearing potential, i.e. premenarchal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal litigation) or,
- •child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
- •Female subjects of child-bearing potential must be willing to use highly effective contraception at trial entry and until completion.
- •30 evaluable subjects without adrenal suppression at baseline will undergo an ACTH-challenge test (Visit 3) and PK assessments (Visit 2 and Visit 3).
- •The ACTH-challenge test as well as PK assessments will only be performed at assigned sites and countries.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A history of hypersensitivity to any component of LEO 90100.
- •Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial:
- •a.etanercept – within 4 weeks prior to V1
- •b.adalimumab, infliximab – within 2 months prior to V1
- •c.ustekinumab – within 4 months prior to V1
- •d.experimental products – within 4 weeks/5 half-lives (whichever is longer) prior to V1
- •Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial.
- •PUVA therapy within 4 weeks prior to V1.
- •UVB therapy within 2 weeks prior to V1 or during the trial.
- •Any topical treatment on the scalp and body including corticosteroids and vitamin D (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to V1 or during the trial.
- •Systemic calcium, vitamin D supplementation > 400 IU/day, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial. (note: stable dose of vitamin D supplementation = 400 IU/day is permitted provided there are no dose adjustments during the study period).
- •Additional exclusion criteria for subjects undergoing HPA axis testing:
- •A history of serious allergy, allergic asthma or serious allergic skin rash.
- •Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide)
- •Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
- •Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.
- •Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2 or during the trial.
- •Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole,metronidazole) within 4 weeks prior to SV2 or during the trial. Topical ketoconazole within 2 weeks prior to SV2.
- •Hypoglycemic sulfonamides within 4 weeks prior to SV2 or during the trial.
- •Antidepressive medications within 4 weeks prior to SV2 or during the trial.
- •Known or suspected endocrine disorder that may affect the results of the ACTH challenge test.
- •Clinical signs or symptoms of Cushing’s disease or Addison’s disease.
- •Subjects with diabetes mellitus.
- •Known or suspected cardiac condition.
- •Not following nocturnal sleep patterns.
研究者
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