NCT05001139已完成不适用
A Multicenter, Open Label, Uncontrolled Study for the Evaluation of Efficacy and Safety by Clinical Parameters of Relizema Ecofoam in Adult Atopic and Contact Dermatitis
Relife S.r.l.2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Number of Participants Who Responded to Treatment With IGA Scale
研究概览
简要总结
The scope of this open label clinical trial is to evaluate and confirm the performance of Relizema ecofoam in the improvement of the dermatitis severity. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 28 days of treatment.
详细描述
The scope of this open label clinical trial is to evaluate and confirm the performance of Relizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology. The product will be applied for 42 days of treatment, 2 times per day into the face.
The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's written informed consent obtained prior to any study-related procedures;
- •Generally healthy male and female aged ≥ 18 years;
- •Presence of atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD) of mild-moderateseverity: ▪ IGA score 2 (=mild) or 3 (=moderate);
- •Dermatitis affecting one or more body areas (face, legs, arms, etc.);
- •Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement.
排除标准
- •Severe dermatitis at inclusion;
- •Pregnant and breastfeeding women;
- •Concomitant other skin disorders including skin infections;
- •Currently or previously diagnosed or treated (chemotherapy and/or radiotherapy) for cancer in the past 5 years;
- •History of previous skin cancer (history of non-metastatic squamous or basal cell carcinoma of the skin is allowed);
- •Active infections or use of antibiotics in the past 7 days;
- •Diabetic subjects;
- •History of congenital or acquired immunodepression;
- •Immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, any typology of lupus, rheumatoid arthritis) which could place the subject at risk or interfere with study results;
- •Use of any topic medication for dermatitis in the past 14 days;
- •Use of any topic product for dermatitis in the 2 days before study treatment start;
- •Any systemic treatment or procedure that could influence dermatitis activity within the past 30 days (or 5 half-lives);
- •Use of any corticosteroids, immunosuppressant drugs or immunotherapy within the past 30 days (or 5 half-lives);
- •Use of oral antihistamines and antidepressants in the past 30 days;
- •Subjects with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations;
- •Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;
- •Concomitant or previous participation in other interventional clinical study in the past 3 months;
- •Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study
结局指标
主要结局
Number of Participants Who Responded to Treatment With IGA Scale
时间窗: after 28 days of treatment
The disease severity will be clinically measured through the Investigator Global Assessment (IGA is based on a five-point scale: 0 = clear 1. = almost clear 2. = mild 3= moderate 4 = severe) for dermatitis after 28 days of treatment.
次要结局
- Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment(after 14, 28 and 42 days of treatment)
- Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment(after 14, 28 and 42 days of treatment)
- Number of Participants Who Responded to Tretment(after 42 days of treatment)
- Unit on a Scale(after 14, 28 and 42 days of treatment)
- to Evaluate the Subject's Overall Acceptability of the Treatment(at the end of the study ( day 42)])
- Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment(after 14, 28 and 42 days of treatment)
- to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam(at the end of the study ( day 42))
研究者
研究点 (2)
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