EUCTR2012-003739-44-BG进行中（未招募）不适用
A Randomised, Double-blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Topically Applied DGLA Cream in Patients with Mild to Moderate Atopic Dermatitis - Safety and Efficacy Study of DGLA Cream in Patients with Atopic Dermatitis
Dignity Sciences Limited0 个研究点目标入组 200 人开始时间: 2013年8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
- 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.Clinically confirmed diagnosis of active atopic dermatitis according to Hanifin and Rajka criteria.
- •2.Patients with mild to moderate atopic dermatitis at screening; Rajka-Langeland score 3-7.5.
- •3. Patients with mild to moderate atopic dermatitis covering 2-50% of the body surface area
- •4.Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
- •5.Patients in general good health as confirmed by a physical examination and by medical history.
- •6.Patients who are able and willing to give signed informed consent (ICF).
- •7.Patient’s body mass index (BMI) is between 18 and 30 kg/m2 inclusive.
- •8.Female patients of child bearing potential, and female partners of male patients, must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) for the duration of the study; or agree to sexual abstinence for the duration of the study. Note: women of non-child bearing potential are:
- •- women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation)
- •- women greater than 60 years of age, or
- •- women greater than 40 and less than 60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH=40 mlU/mL) or cessation of menses for at least 24 months without FSH levels confirmed.
- •9.Patients who are able and willing to stop treatment for atopic dermatitis for the washout period (except emollients).
- •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 195
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Females with positive pregnancy test at screening (Visit 1) or start of treatment/baseline (Visit 2) or lactating women.
- •2.Patients who have received phototherapy (UVA, UVB) within 4 weeks of screening (Visit 1).
- •3.Patients with Netherton’s Syndrome.
- •4.Patients with clinically significant impairment of renal or hepatic function.
- •5.Patients with other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis, viral, bacterial and fungal skin infections).
- •6.Patients with a history of hypersensitivity to any substance in the IMP.
- •7.Patients with severe atopic dermatitis; Rajka-Langeland score 8-9.
- •8.Patients with a history of clinically relevant ECG abnormalities
- •9.Patients treated with any experimental drug within 30 days prior to start of treatment/baseline visit (Visit 2).
- •10.Patients who have used any of the medications and therapeutic regimens excluded from the study within 14 days prior to baseline/day 0 visit (Visit 2).
- •11.Patients with a significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease.
- •12.Patients with a medical history of chronic infectious disease (HCV, HBV, HIV).
研究者
相似试验
进行中（未招募）
不适用
Safety and Efficacy Study of DGLA Cream in Patients with Atopic DermatitisAtopic DermatitisEUCTR2012-003739-44-FIDignity Sciences Limited200
进行中（未招募）
1 期
Safety and Efficacy Study of DGLA Cream in Patients with Atopic DermatitisAtopic DermatitisEUCTR2012-003739-44-DKDignity Sciences Limited200
进行中（未招募）
1 期
Safety and Efficacy Study of DGLA Cream in Patients with Acne VulgarisPatients with mild to moderate facial papulopustular acne (acne comedonica or acne papulopustulosa) will be enrolled in the study.MedDRA version: 14.1Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858EUCTR2012-004965-41-SKDignity Sciences Limited150
进行中（未招募）
不适用
Safety and Efficacy Study of DGLA Cream in Patients with Atopic DermatitisMedDRA version: 14.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic DermatitisEUCTR2012-003739-44-SEDignity Sciences Limited200
进行中（未招募）
不适用
Safety and Efficacy Study of DGLA Cream in Patients with Acne VulgarisPatients with mild to moderate facial papulopustular acne (acne comedonica or acne papulopustulosa) will be enrolled in the study.MedDRA version: 15.1Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858EUCTR2012-004965-41-HUDignity Sciences Limited150