EUCTR2005-003215-78-GB进行中（未招募）1 期
Calcipotriol plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle and the Gel Vehicle alone in Psoriasis Vulgaris.
EO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)0 个研究点目标入组 0 人开始时间: 2005年10月4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
入选标准
- •1. Signed and dated informed consent has been obtained.
- •2. Clinical diagnoses of psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week.
- •3. An investigators’ global assessment of disease severity of at least mild.
- •4. Aged 18 years or above.
- •5. Either sex.
- •6. Any ethnic origin.
- •7. Attending hospital outpatient clinic or the private practice of a dermatologist.
- •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 psoriasis vulgaris (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 psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppres-sants) within 4 weeks prior to randomisation.
- •5. Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation.
- •6. Topical treatment for other relevant skin disorders (e.g., face psoriasis, scalp psoriasis, flexural psoriasis, eczema) within 2 weeks prior to randomisation. However, the following therapy is allowed on the face, scalp and flexures but not on the trunk and limbs within 2 weeks prior to randomisation: WHO group I-II corticosteroids, tar, reti-noid or dithranol products.
- •7. Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study.
- •8. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- •9. Patients with any of the following conditions present on the treatment area: Viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin.
- •10. Known or suspected abnormality of calcium homeostasis known to be associated with clinically significant hypercalcaemia.
- •11. Planned exposure to sun during the study that may affect the psoriasis vulgaris.
- •12. Known or suspected hypersentivity to component(s) of the Investigational Products.
- •13. Current participation in any other interventional study.
- •14. 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 registration) within a month prior to randomisation.
- •15. Previously randomised in this study.
- •16. Patients known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g., due to alcoholism, drug dependence or psychotic state)
- •17. Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the study, or are breast-feeding.
- •18. 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.
- •19. Trial subjects not using an adequate method of contraception during the study.
研究者
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