EUCTR2007-002182-12-GB进行中（未招募）1 期
A SINGLE CENTER, SINGLE-BLIND, PARALLEL GROUP CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF W0153 VS. STANDARD MOISTURIZER IN THE MAINTENANCE OF PATIENTS WITH ATOPIC DERMATITIS
Stiefel Laboratories0 个研究点目标入组 200 人开始时间: 2007年5月30日最近更新:
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
- 入组人数
- 200
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.Subjects with mild-to-moderate AD based on Hanifin and Rajka diagnosis criteria and Rajka and Langeland grading system (score of 3 to 7.5).
- •2.An Investigator’s Global Assessment (IGA) score of 2 or 3.
- •3.Subjects of either sex aged 2 to 65 years.
- •4.Subjects who are willing and able to provide written informed consent. For subjects aged under 16 years of age, assent (where appropriate) and parental/guardian consent must be obtained.
- •5.Subjects (and/or parent/guardian) who agree to utilise subject diaries for the purposes of recording their (their childs) responses to questions regarding the signs and symptoms of their AD.
- •6.Subjects who are prepared to use the trial products and standardised washing regimen as instructed for the duration of the trial in place of their normal product and regimen.
- •7.Sexually active females of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A female of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects with severe AD who require systemic or very-potent topical steroid treatment.
- •2.Subjects with facial AD.
- •3.Subjects with acutely infected AD, or areas where the lesions are crusted, weeping, or pustular.
- •4.Female subjects who are pregnant or lactating.
- •5.Subjects who are currently receiving or who have received during the 14 days before study entry, topical or systemic therapy likely to interfere with the study (e.g., antibiotic therapy, corticosteroids, anti-histamines, immunomodulators, anti-inflammatory agents).
- •6.Subjects who have participated, who are currently participating or who plan to participate in any other research study involving an investigational product or device at any time during and after the 4 weeks before study entry.
- •7.Subjects with any significant concurrent illness including psoriasis, rosacea, acne vulgaris, peri-oral dermatitis and primary skin lesions caused by infection with fungi or bacteria.
- •8.Subjects with a history of skin disease, other than AD, or allergy, likely to interfere with the study.
- •9.Subjects considered unable or unlikely to attend the necessary visits.
- •10.Employees or an immediate family member (partner, offspring, parents, siblings, or sibling’s offspring) of an employee of Euroderm Research or Stiefel Laboratories.
- •11.Subjects with past medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor, cancer or psychiatric disease, which, in the opinion of the Investigator would compromise the safety of the subject or affect the outcome of the study.
- •12.Subjects with known sensitivity to the test product ingredients.
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