EUCTR2010-021941-38-DE进行中（未招募）不适用
EO 90110 ointment in the treatment of psoriasis vulgaris
EO Pharma A/S0 个研究点目标入组 88 人开始时间: 2010年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
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.Following verbal and written information about the trial, the subject has provided signed and dated in-formed consent before any study related activity is carried out, including activities relating to the wash-out period
- •2.Clinical diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk amenable for topical treatment
- •3.Two symmetrically distributed lesions, one on each side of the body, located on arms, legs or trunk, fulfilling the following criteria:
- •Each lesion of minimum 0.5% and maximum 1% of total body surface area. The two lesions should be of similar size according to the Investigator’s judge-ment.
- •b. Total Clinical Score
- •Each lesion with a Total Clinical Score of at least 5. Any difference in Total Clinical Score between the two lesions should be of maximum ‘1’.
- •c. Severity
- •Severity of each lesion at least mild according to Investigator’s Global Assessment. Severity score must be the same for both lesions.
- •4.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. Systemic treatment with biological therapies
- •directed against or with a potential effect on psoriasis
- •vulgaris, within the following time period:
- •- etanercept: within 4 weeks prior to randomisation
- •- adalimumab, infliximab: within 2 months prior to
- •randomisation
- •- alefacept, ustekinumab: within 4 months prior to
- •randomisation
- •2. Systemic treatment with all other than biological
- •therapies with a potential effect on psoriasis vulgaris
- •(e.g. corticosteroids, retinoids, immunosuppressants,
- •salazopyrin) within 4 weeks prior to randomisation
- •3. PUVA therapy or Grenz ray therapy within 4
- •weeks prior to randomisation
- •4. UVB therapy within 2 weeks prior to randomisation
- •5. Topical treatment with potent or very potent WHO
- •group III and IV corticosteroids within 2 weeks
- •prior to randomisation
- •6. Any topical treatment (except for emollients) of
- •the two selected target lesions within 2 weeks prior
- •to randomisation
- •7. Planned initiation of, or planned changes to,
- •concomitant medication that may affect psoriasis
- •vulgaris (e.g., beta blockers, chloroquine, lithium
- •and ACE inhibitors) within 2 weeks prior to randomisation
- •and during the study
- •8. Treatment with drugs sensitive to CYP3A4 or
- •CYP2D6 metabolism within 5 half lives prior to randomisation
- •9. Current diagnosis of guttate, erythrodermic,
- •exfoliative or pustular psoriasis
- •10. Any of the following conditions present on the two
- •selected target lesions: Infectious skin disorder,
- •eczematous skin, atopic dermatitis, ulcers or wounds
- •11. Skin disease on the two selected target lesions that
- •may confound the evaluation of psoriasis vulgaris
- •(e.g., seborrhoiec dermatitis, contact dermatitis or
- •fungal infection) as judged by the Investigator
- •12. Planned exposure to the sun during the study that
- •may affect psoriasis vulgaris (i.e., normal lifestyle
- •outdoor activities are permitted but deliberate exposure
- •to sunlight or artificial ultraviolet light to the
- •two selected target lesions should be avoided)
- •13. Clinically significant cardiac, endocrinologic,
- •pulmonary, neurologic, psychiatric, hepatic, renal,
- •haematologic, malignant or gastrointestinal disease,
- •immunologic insufficiency, or other major diseases
- •or current condition which, in the opinion of the
- •Investigator, would put the subject at risk by participating
- •in the study or would interfere with the
- •evaluation of study results
- 另有 24 项未显示
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