A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LEO 90100 Aerosol Foam Compared to Betesil® Medicated Plaster in the Treatment of Psoriasis Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline
研究概览
简要总结
The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster
详细描述
The products will be applied on 6 test sites (each product on 3 test sites) once daily 6 days a week (except Sundays) for 4 weeks. The application sites for each product will be determined according to random assignment. Depending on the size of the psoriasis plaques, 2 or 4 test sites will be located within the same plaque; the treatment assignment will be done pair-wise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 with a diagnosis of psoriasis vulgaris with preferably three lesions (plaques) located on arms, legs and/or trunk or at least two lesions (plaques) located on arms, legs and/or trunk. For subjects with three lesions, each lesion must have a size suitable to accommodate 2 test sites (test site area 5 cm2, distance between two test sites at least 2 cm). For subjects with two lesions, one lesion must have a size suitable to accommodate 4 test sites, and the other lesion must accommodate 2 test sites.
- •Age 18 years or above
- •Outpatients
- •Female subjects must be of either
- •non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
- •child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
排除标准
- •Female subjects who are breast feeding
- •Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- •Etanercept - within 4 weeks prior to randomisation and during the trial
- •Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial
- •Ustekinumab - within 16 weeks prior to randomisation and during the trial
- •Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)
- •Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial
- •Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
- •PUVA: 4 weeks
- •UVB: 2 weeks
- •Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:
- •Potent or very potent (WHO group III-IV) corticosteroids
- •Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:
- •WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
- •Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid
- •Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
- •Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
- •Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
研究组 & 干预措施
LEO 90100 Aerosol foam
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
干预措施: LEO 90100 Aerosol foam (Drug)
Betesil® 2.25 mg
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone).(Betesil® )
干预措施: Betesil® 2.25 mg (Drug)
结局指标
主要结局
Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline
时间窗: Day 1 (Baseline) to Day 29
The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe). The total TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site. Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT). The mean TCS at Baseline was 6.6 for both groups.
次要结局
- Change in Score of Erythema, Scaling, and Infiltration at Individual Visits(Day 1 (Baseline) to Day 29)
- Change in TCS at Individual Visits(Day 1 (Baseline) to Day 29)
- Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT(Baseline to End of Treatment)