NL-OMON42757已完成2 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 psoriasis - A 4-week trial in adolescent subjects with plaque psoriasis.
eo Pharma0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •Main criteria for inclusion (all subjects)
- •- 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.;Main criteria for inclusion (for subjects undergoing HPA axis testing:)
- •- Plaque psoriasis on trunk and/or limbs affecting at least 10% BSA.
- •- Plaque psoriasis on the scalp affecting at least 20% of total scalp area.
- •- PGA score of at least moderate on trunk and limbs at SV1, SV2 and V1.
- •- PGA score of at least moderate on scalp at SV1, SV2 and V1.
- •- Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge).
排除标准
- •Main criteria for exclusion (for all subjects):
- •- 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).;Main criteria for exclusion (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®/Synacthen®(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.
研究者
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