EUCTR2006-003073-27-DE进行中（未招募）1 期
Subject preference comparison between Clobetasol propionate shampoo, 0.05% and three other topical corticosteroids in the treatment of moderate to severe Scalp psoriasis - Subject preference of topical corticosteroids in scalp psoriasis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galderma R&D
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
- •Inclusion Criteria to enter Treatment Period I”
- •1. Male or female subjects, 18 years of age or older,
- •2. Subjects with moderate to severe scalp psoriasis (defined as global severity score of at least 3 on a 6-point scale),
- •3. Female subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral contraception, IUD, systemic (injectable or patch) contraception, strict abstinence or partner had a vasectomy,
- •4. Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, are not required to have a UPT at the beginning of the study,
- •5. Subjects who signed written informed consent prior to any study procedures,
- •6. Subjects willing and capable of cooperating to the extent and degree required by the protocol,
- •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. Subjects who need systemic treatment for their body psoriasis,
- •2. Subjects who are at risk in terms of precautions, warnings and contra-indication 3. Female subjects who are pregnant, nursing or planning a pregnancy during the study,
- •4. Subjects who have participated in another investigational drug or device research study within 30 days of enrolment,
- •5. Subjects with a washout period for topical treatment(s) on the scalp less than:
- •Corticosteroids2 weeks
- •All other anti-psoriasis medications (including, but not restricted to: vitamin D derivatives, retinoids, salicylic acid, urea, coal tar and anthralin)2 weeks
- •UV-light therapy2 weeks
- •6. Subjects with a washout period for systemic treatment(s) less than:
- •PUVA therapy4 weeks
- •Biological therapies (e.g. alefacept, efalizumab, etanercept, infliximab) 12 weeks
- •Treatments other than biologicals with a possible efficacy on psoriasis (such as acitretin, isotretinoin, methotrexate, cyclosporine, corticosteroid, hydroxycarbamide, azathioprine )4 weeks
- •Treatment known to worsen psoriasis (such as lithium, beta-blockers, antimalarials, ACE inhibitors)*2 weeks
- •* NOTE: unless subjects have been on treatment for at least 6 months and their psoriasis considered stable at study inclusion
- •7. Subjects with an history of adverse response (either severe side-effects or corticoresistance) to topical or systemic steroid therapy,
- •8. Subjects who plan to have intensive UV sun exposure during the study (mountain sports, UV radiation, sunbathing, etc…),
- •9. Subject with a condition or who is in a situation which, in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study.
研究者
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