EUCTR2004-002152-33-FI进行中（未招募）1 期
Calcipotriol plus Betamethasone Dipropionate Gel Compared to Calcipotriol in the Gel Vehicle and Betamethasone Dipropionate in the Gel Vehicle in Scalp Psoriasis.A phase III study comparing a gel containing calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g (as dipropionate) with calcipotriol 50 mcg/g in the gel vehicle and betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, all applied once daily in the treatment of scalp psoriasis.
EO Pharma A/S0 个研究点目标入组 0 人开始时间: 2004年9月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Scalp psoriasis amenable to topical treatment with a maximum of 100 g of medica-tion per week
- •2. Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
- •3. Extent of scalp psoriasis involving more than 10% of the total scalp area
- •4. Investigator’s assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs
- •5. Disease severity on the scalp graded as Moderate, Severe or Very severe ac-cording to the investigator’s global assessment of disease severity
- •6. Patients aged 18 years or above
- •7. Either sex
- •8. Any ethnic origin
- •9. Attending a hospital out-patient clinic, the private practice of a dermatologist or the practice of a general practitioner experienced in the handling of psoriasis vulgaris
- •10. Following receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is car-ried out, including washout
- •11. Patients fulfilling national requirements/law for participation in this study
- •6.Patients aged 18 years or above
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. PUVA or Grenz ray therapy within 4 weeks prior to randomisation
- •2. UVB therapy within 2 weeks prior to randomisation
- •3. Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisation
- •4. Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosup-pressants) within 4 weeks prior to randomisation
- •5. Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation
- •6. Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
- •7. Planned initiation of, or changes to concomitant medication that could affect scalp psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the study
- •8. Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
- •9. Patients with any of the following conditions present on the scalp area: Viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
- •10. Known or suspected abnormality of the calcium homeostasis associated with clinically significant hypercalcaemia
- •11. Known or suspected severe renal insufficiency or severe hepatic disorders
- •12. Planned exposure to sun during the study, that may affect scalp psoriasis
- •13. Known or suspected hypersensitivity to component(s) of the Investigational Products
- •14. Current participation in any other interventional clinical study
- •15. Patients who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registra-tion) within a month prior to randomisation
- •16. Previously randomised and having received at least one treatment application in this study
- •17. Patients known or suspected of not being able to comply with a trial protocol (e.g., due to alcoholism, drug dependency or psychotic state)
- •18. Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the study, or are breast feeding
- •19. Females of child-bearing potential with positive pregnancy test at Visit 1 (all females of child-bearing potential must have a pregnancy test at Visit 1 and should further-more be willing to use an adequate method of contraception during the study)
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