A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for 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
- 24
- 试验地点
- 1
- 主要终点
- Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
研究概览
简要总结
The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •(in summary)
- •Subjects having understood and signed an informed consent form
- •All skin types
- •Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
- •Subjects willing and able to follow all the study procedures and complete the whole study
- •Subjects affiliated to social security system
排除标准
- •(in summary)
- •Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
- •Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
- •Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
- •Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy
- •Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
- •Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
研究组 & 干预措施
LEO 29102 cream
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks
干预措施: LEO 29102 cream (Drug)
LEO 29102 Cream Vehicle
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
干预措施: LEO 29102 Cream Vehicle (Drug)
Betamethasone Dipropionate Cream
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
干预措施: Betamethasone Dipropionate Cream (Drug)
LEO 29102 Plus Calcipotriol Cream
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
干预措施: LEO 29102 Plus Calcipotriol Cream (Drug)
LEO 29102 Plus Betamethasone Dipropionate
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
干预措施: LEO 29102 Plus Betamethasone Dipropionate (Drug)
Daivobet® Ointment
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
干预措施: Daivobet® Ointment (Drug)
结局指标
主要结局
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
时间窗: From baseline (Day 1) to end of treatment (Day 29)
The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).
次要结局
- Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline(From baseline (Day 1) to end of treatment (Day 29))
- Pathology and Histology by Treatment: Epidermal Thickness(At end of treatment)
- Change in Scaling Compared to Baseline(At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25)
- Biomarkers by Immunochemistry: Epidermal Differentiation(At end of treatment)
- Biomarkers by Immunochemistry: Epidermal Proliferation(At end of treatment)
- Pathology and Histology by Treatment(At end of treatment)
- Change in Infiltration Compared to Baseline(At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25)
- Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound(At Day 8, Day 15, Day 22 and end of treatment)
- Change in Erythema Compared to Baseline(At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25)
- Biomarkers by Immunochemistry(At end of treatment)
- Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses(At end of treatment)
- Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline(At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25)