EUCTR2011-004640-21-GB进行中（未招募）不适用
A Randomized, Placebo-controlled Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w topical CT327 when Applied Twice Daily in Subjects with Psoriasis Vulgaris. - CT327 Phase IIb Psoriasis Study
Creabilis Limited0 个研究点目标入组 160 人开始时间: 2012年2月2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
- 160
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. Male and female subjects aged >18 years. 2. Willing and able to give written informed consent. 3. Diagnosis of stable psoriasis vulgaris (PV) 4. IGA score of at least mild 5. A minimum mPASI score of 2 in at least one body region i.e. psoriasis affecting up to 10% of arms, and/or 10% of trunk, and/or 10% of legs PV affecting up to 10% of the subject's body surface area (excluding the face and scalp). 6. Amenable to treatment with topical treatment. 7. At least one target plaque with a plaque elevation of at least moderate severity (grade =3 on mPASI severity scale). 8. Subjects who are willing to avoid exposure to sun, UVA, or UVB from screening until the end of the study. 9. Subjects who are willing and able to comply with the study instructions, apply the study medication as directed and attend all scheduled visits. 10. Females of child-bearing potential must have a negative urine pregnancy test before randomization and must agree to use an adequate contraception during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. 2. Subjects with psoriasis that includes the groin, axillae, and other intertriginous areas. 3. Subjects taking concomitant dermatologic treatments or with concomitant medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug. 4. Subjects with a clinical diagnosis of bacterial infection of the skin including impetigo and abscesses. 5. Subjects undergoing systemic anti-psoriatic treatment or PUVA therapy within 4 weeks prior to visit 1 or planned treatment during the study. 6. Subjects receiving UVB therapy within the 2 weeks prior to visit 1 or planning to receive it during the study. 7. Subjects who have received monoclonal antibody therapy in the 4 months prior to screening. 8. Subjects using topical psoriatic treatments including corticosteroids, retinoids and vitamin D derivatives in the two weeks prior to visit 1 or who would require treatment with these agents during the study. The use of an emollient or topical salicylic acid derivative for facial or scalp lesions is allowed. 9. Subjects taking or scheduled to start non antipsoriatic concomitant medication that could affect psoriasis (e.g. immunosuppressants, beta blockers, lithium) during the study. 10. Female subjects who are pregnant or lactating, or intend to become pregnant during the study or within a month of study completion. 11. Subjects who have any clinically significant abnormal clinical laboratory test results at screening. 12. Subjects who have received any investigational drug or taken part in any clinical study within three months prior to the study start. 13. Subjects with a known reaction or allergy to the test drug or excipients. 14. Any subjects with major medical illness or symptoms of a clinically significant illness that may influence the study outcome. 15. Obese subjects should be excluded if the opinion of the investigator the condition is likely to impact the assessment of their psoriasis and impede their ability to apply the study medication. 16. Subjects who in the opinion of the investigator, have any acute chronic medical or psychiatric condition or laboratory abnormality which would make them unsuitable for participation in this study or which places the subject at undue risk (e.g. history of drug, alcohol or other substance abuse) or other factors limiting the ability of the subject to co-operate and to comply with this protocol.
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