NCT00691002已完成3 期
Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 1,245
- 试验地点
- 11
- 主要终点
- Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase
研究概览
简要总结
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the safety and efficacy will be evaluated for up to 60 weeks treatment as required of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face and intertriginous areas (= open-label phase).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Clinical diagnosis of psoriasis vulgaris involving the face
- •Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
- •An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
- •Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 100 g of ointment per week
- •Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face
排除标准
- •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
- •Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
- •PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
- •UVB therapy within the 2-week period prior to randomisation
- •Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the double-blind phase of the study)
- •Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
- •Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
- •Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
- •Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, 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
- •Other inflammatory skin diseases (e.g., seborrhoiec dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psorisis vulgaris on the face or on the intertriginous areas
- •Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study
- •Known or suspected severe renal insufficiency or severe hepatic disorders
- •Known or suspected disorders of calcium metabolism associated with hypercalcaemia
研究组 & 干预措施
LEO 80190
Experimental
Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190)
干预措施: Calcipotriol plus hydrocortisone (LEO 80190) (Drug)
LEO 80190 vehicle
Placebo Comparator
Ointment Vehicle
干预措施: LEO 80190 Vehicle (Drug)
Calcipotriol
Active Comparator
Calcipotriol 25 mcg/g in the ointment vehicle
干预措施: Calcipotriol (Drug)
Hydrocortisone
Active Comparator
Hydrocortisone 10 mg/g in the ointment vehicle
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase
时间窗: At Week 8 (end of treatment for double-blind phase)
The (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline (Visit 1) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline (Visit 1) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.
次要结局
- Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase(At Week 4)
- Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase(At Week 8 (end of treatment for double-blind phase))
- Participants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase(At Week 8 (end of treatment for double-blind phase))
- Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase(At Week 8 (end of treatment for double-blind phase))
研究者
研究点 (11)
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进行中（未招募）
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Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas. A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas, followed by a 52-week safety study in patients with psoriasis vulgaris on the face and on the intertriginous areas.Psoriasis vulgaris on the face and on the intertriginous areas The face is defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus). In case of baldness or partial baldness, the forehead should be estimated considering standard or previous hairline. The intertriginous areas are defined as: 1) the axillae, 2) the genito-femoral and inguinal folds, 3) the inframammary folds, 4) the intergluteal folds and 5) the scrotum.MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgarisEUCTR2007-004782-18-GBEO Pharmaceuticals Products Ltd. A/S (LEO Pharma A/S)1,225
进行中（未招募）
不适用
Calcipotriol Plus Hydrocortisone in Psoriasis Vulgarison the Face and on the Intertriginous Areas. A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas, followed by a 52-week safety study in patients with psoriasis vulgaris on the face and on the intertriginous areas.Psoriasis vulgaris on the face and on the intertriginous areasThe face is defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus). In case of baldness or partial baldness, the forehead should be estimated considering standard or previous hairline.The intertriginous areas are defined as: 1) the axillae, 2) the genito-femoral and inguinal folds, 3) the inframammary folds, 4) the intergluteal folds and 5) the scrotum.MedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisEUCTR2007-004782-18-SIEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)1,225
进行中（未招募）
不适用
Calcipotriol Plus Hydrocortisone in Psoriasis Vulgarison the Face and on the Intertriginous Areas. A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas, followed by a 52-week safety study in patients with psoriasis vulgaris on the face and on the intertriginous areas.Psoriasis vulgaris on the face and on the intertriginous areasThe face is defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus). In case of baldness or partial baldness, the forehead should be estimated considering standard or previous hairline.The intertriginous areas are defined as: 1) the axillae, 2) the genito-femoral and inguinal folds, 3) the inframammary folds, 4) the intergluteal folds and 5) the scrotum.MedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisEUCTR2007-004782-18-CZEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)1,225
进行中（未招募）
不适用
Calcipotriol Plus Hydrocortisone in Psoriasis Vulgarison the Face and on the Intertriginous Areas. A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas, followed by a 52-week safety study in patients with psoriasis vulgaris on the face and on the intertriginous areas.Psoriasis vulgaris on the face and on the intertriginous areasThe face is defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus). In case of baldness or partial baldness, the forehead should be estimated considering standard or previous hairline.The intertriginous areas are defined as: 1) the axillae, 2) the genito-femoral and inguinal folds, 3) the inframammary folds, 4) the intergluteal folds and 5) the scrotum.MedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisEUCTR2007-004782-18-NLEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)1,225