A phase II randomised, double blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of CT327 topical ointment (0.05% and 0.5% w/w) compared to vehicle, in subjects with mild or moderate atopic dermatitis with at least moderate pruritus - CT327 Phase IIb Atopic Dermatitis Study

Creabilis Limited0 个研究点目标入组 210 人开始时间: 2013年3月19日最近更新: 2014年6月30日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 210

研究概览入排标准研究者记录与标识符相似试验

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. Informed consent signed and dated by the subject or the subject’s parent/legal guardian, with assent from the subject, if appropriate. 2. Male and female subjects aged = 12 years. 3. Clinical diagnosis of atopic dermatitis (as defined by Hanifin and Rajka criteria) with: • IGA score of 2 or 3 (mild or moderate) • Score of = 40mm on all screening pruritus VAS assessments (average and worst over the last 24 hours and current itch) • A minimum of 5% and not more than 20% of the subjects’ BSA affected by atopic dermatitis (affected is defined as active atopic dermatitis lesions or pruritus) • Amenable to treatment with topical treatment • Stable disease for =1 months prior to screening 4. The subject and/or the subject’s legal guardian must be willing and able to comply with the study instructions (Section 4.5), apply the study medication as directed and attend all scheduled visits. 5. Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and before the start of study treatment. 6. Any subject who is sexually active must agree to use an effective contraceptive method throughout the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 63
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 147
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

排除标准

•1. Atopic dermatitis only affecting the head or scalp. 2. Unstable or actively infected atopic dermatitis. 3. Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug. 4. Subjects who have received monoclonal antibody therapy for their atopic dermatitis in the 4 months prior to screening. 5. Subjects who have used systemic immunosuppressive drugs, corticosteroids or received PUVA therapy in the 4 weeks prior to starting study treatment, or are scheduled to start these treatments during the study period. 6. Subjects who have used topical immunomodulators (pimecrolimus, tacrolimus) within 2 weeks of starting study treatment or are scheduled to start these treatments during the study period. 7. Subjects who have used topical corticosteroids from WHO group II, III or IV, or other treatments for atopic dermatitis, including wet wraps, within 2 weeks prior to starting study treatment or are likely to require treatment with these medications during the study period. 8. Subjects who are unable to abstain from using emollients from baseline (Visit 2) until the end of study treatment (Visit 6). 9. Subjects who are using any concomitant medication(s) that, in the investigators’ opinion, could affect the subject’s atopic dermatitis or pruritus (for example TADs, SSRI, pregabalin). Subjects using such medications may be included, at the investigators discretion, if they have been stable on treatment for at least 1 month prior to the start of study treatment and no changes to these medications are planned during the study period. 10. Subjects undergoing, or due to have, UVA, or UVB therapy in the 2 weeks prior to starting study treatment or during the study period. 11. Planned exposure of affected areas to excessive sunlight. 12. Subjects who have used fake tanning products in the 2 weeks prior to screening or those who are intending to use these products during the study period. 13. Female subjects who are pregnant and lactating mothers. 14. Subjects with a clinically significant abnormal laboratory safety test and/or 12-lead ECG results at screening. 15. Subjects who are receiving any investigational drug or who have taken part in a clinical study with an investigational drug within three months prior to the start of study treatment. 16. Subjects with a known reaction or allergy to test drug or excipients. 17. Subjects who in the opinion of the investigator, have any acute chronic medical or psychiatric condition 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.

研究者

发起方

Creabilis Limited

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