EUCTR2012-000253-30-DE进行中（未招募）1 期
An exploratory study evaluating the efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis
EO Pharma A/S0 个研究点目标入组 30 人开始时间: 2012年9月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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.Signed informed consent has been obtained
- •2.Age 18 years or above
- •3.Either sex
- •4.Any race or ethnicity
- •5.Attending hospital outpatient clinic or the private practice of a dermatologist
- •6.Clinical diagnosis of stable plaque psoriasis of at least 6 months with a symmetric distribution
- •7.Two treatment areas with a symmetrical distribution each corresponding to 2-3% BSA and each including at least one itchy psoriasis plaque
- •8.Itchy psoriasis on both intended treatment areas of at least 40mm on the Visual Analogue Scale (VAS) with a maximum difference of 10mm on the visual ana-logue scale between each of the two treatment areas
- •9.Disease severity graded mild, moderate or severe according to the Physician’s global assessment (PGA) of disease severity on psoriasis plaques on each of the two treatment areas. The disease severity must be the same for both treatment areas
- •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 28
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- •etanercept – within 4 weeks prior to randomisa-tion
- •adalimumab, infliximab – within 8 weeks prior to randomisation
- •ustekinumab – within 16 weeks prior to randomisation
- •other products – 4 weeks/5 half-lives (whichev-er is longer)
- •2.Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticoster-oids, retinoids, methotrexate, ciclosporin, fumaric acid derivatives, and other immunosuppressants) within 4 weeks prior to randomization
- •3.Any topical treatment of the treatment areas (except for emollients) within 2 weeks prior to randomisation.
- •4.Treatment with therapies, whether marketed or not, with a possible effect on itch within the following time periods prior to randomisation:
- •antihistamins – within 1 week prior to randomi-sation
- •gabapentin – within 4 weeks prior to randomi-sation
- •5.Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following regis-tration) within the 4-week period prior to randomisa-tion or longer, if the class of substance required a longer treatment free period as defined in exclusion criterion 1 for biological treatments
- •6.PUVA or Grenz ray therapy within 4 weeks prior to randomisation.
- •7.UVB therapy within 2 weeks prior to randomisation
- •8.Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) within 2 weeks prior to randomisation
- •9.Subjects with current participation in any other interventional clinical trial
- •10.Subjects with any of the following conditions present on the treatment areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infec-tions, parasitic infections, skin manifestations in rela-tion to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ic-thyosis, ulcers and wounds
- •11.Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis
- •12.Subjects with a history of serious allergy, allergic skin rash or sensitivity to any component of the investiga-tional products or formulations being tested
- •13.Known or suspected severe renal insufficiency or severe hepatic disorders
- •14.Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
- •15.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 should be avoid-ed)
- •16.Subjects previously randomised into this trial
- •17.Subjects known or, in the opinion of the investigator, being unlikely to comply with the Clinical Study Pro-tocol (e.g., due to alcoholism, drug dependency or psychotic state)
- •18.Females who are pregnant, females of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
- •19.Females of child-bearing potential with positive pregnancy test at visit 1
- •20.Subjects (or their partner) not using an adequate method of contraception (according to national re-quirements, as applicable)
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