EUCTR2005-002471-32-GB进行中（未招募）1 期
A PHASE II, SINGLE-CENTRE, INVESTIGATOR-BLIND, PARALLEL GROUP CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF 1% CICLOPIROX OLAMINE (BATRAFEN® CREAM), COMPARED TO 1% HYDROCORTISONE ACETATE (HC45® CREAM), COMPARED TO A TOPICAL EMOLLIENT (E45® CREAM), IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE ATOPIC ECZEMA
Stiefel Laboratories Maidenhead Ltd (commonly known as Stiefel International R&D)0 个研究点开始时间: 2005年7月1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
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) Patients fulfilling the Hanifin and Rajka diagnostic criteria for atopic dermatitis.
- •2) Patients diagnosed with mild to moderate atopic eczema, as defined by a SASSAD score of = 10 and = 30.
- •3) Patients of either sex aged 8 years and over.
- •4) Patients who are willing and able to provide written informed consent, after being informed of all the pertinent aspects of the trial. In the case of patients aged under 16 years of age, parental or guardian consent must be obtained in addition to patient assent.
- •5) Patients who are willing/ able to limit bathing/ showering to a maximum of once daily, without additional bath emollient.
- •6) Patients who are willing/ able to use a standard aqueous cream for washing.
- •7) Patients agreeing to minimise their alcohol consumption throughout the study, with a limit of 14 units per week.
- •8) Patients who agree to utilise the IVR system for the purposes of recording their responses to questions regarding the signs and symptoms of their eczema.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Patients with acutely infected eczema, or areas where the lesions are crusted, weeping or pustular.
- •2) Patients who have severe eczema on their face or eyes, ano-genital area or severe broken skin or infected skin, e.g., impetigo, cold sores, acne or athlete’s foot.
- •3) Patients who have received antibiotic therapy in the previous 2 weeks of entry into the study.
- •4) Patients who have received significant topical or systemic therapy likely to interfere with the study (e.g., corticosteroids, anti-histamines, immunomodulators, anti-inflammatory agents) in the previous 2 weeks prior to entry into the study.
- •5) Patients using, or having used in the past month, any significant concomitant medication which might affect their eczema, as judged by the Investigator.
- •6) Patients who have a significant concurrent illness which might affect their eczema, as judged by the Investigator.
- •7) Patients who have a history of allergic, hypersensitivity or idiosyncratic reaction to any of the active ingredients or any components of the study medications.
- •8) Female patients who are pregnant, breast-feeding, or sexually active and not using reliable contraception and/or not prepared to do so for the duration of the trial (a negative pregnancy test must be confirmed at Visit 1 and at the end of the study, for all females if menarche has occurred). A pregnancy test is not required for female patients who are two years post menopausal, or where in the opinion of the investigator a pregnancy test is not appropriate.
- •9) Patients who are unreliable or unlikely to be available for the duration of the follow-up.
- •10) Patients who have participated in a clinical trial involving a drug within 30 days of recruitment into the study (or are likely to do so at any time during their participation).
- •11) Patients with a history of alcohol or drug abuse.
- •12) Patients who are either an immediate family member, or a colleague, of study personnel.
- •13) Patients who already have a member of their household entered onto this trial.
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