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临床试验/NCT01597817
NCT01597817已完成2 期

A Randomized Controlled Trial of the Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis

Universidade do Porto1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
78
试验地点
1
主要终点
Score of severity of Atopic Dermatitis (SCORAD)

研究概览

简要总结

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by exacerbations and remission of intensely pruritic lesions of variable location. AD may be acute (short-term and severe) with predominantly redness, vesicles and oozing, or it may be chronic (long-term) with scaling, skin thickening, altered pigmentation and exaggerated surface markings. The condition affects mainly the creases of the elbows and knees, and the face and neck, although it can affect any part of the body. The severity of AD is variable, ranging from localized mild scaling to generalized involvement of the whole body. Itching is the predominant symptom, which can induce a vicious cycle of scratching, leading to skin damage. There is a tendency to lifelong dry sensitive skin. Skin of AD is often colonized by Staphylococcus aureus contributing to perpetuating cutaneous inflammation. AD treatment is based on skin hydration, identification and elimination of flare factors, and pharmacologic therapy. Biofunctional textiles are emerging as new and complementary tools . Chitosan is a natural polysaccharide with in vitro anti-microbial activity and regenerating properties. The investigators aim to evaluate the effect of a textile coated with chitosan in AD treatment as well as its impact on systemic inflammation and skin microbiome. The investigators hypothesize the use of biofunctional textile coated with chitosan will improve severity of AD , quality of life and diminish skin colonization with Staphylococcus aureus and some skin moulds, namely Malassezia.

详细描述

This randomized controlled trial will examine the efficacy and safety of a bio functional textile in the treatment of atopic dermatitis (AD).

Atopic dermatitis subjects will be randomized to placebo or active group and asked to wear cotton long sleeved shirts and pants (single cotton versus cotton coated with chitosan)as pyjamas during the night for a 2 month period.

Atopic dermatitis is defined by Haniffin and Rafka criteria (Rothe MJ et al 2006) - must have three or more of major criteria

  1. Pruritus

  2. Typical morphology and distribution

  3. Flexural lichenification or linearity in adults

  4. Facial and extensor involvement in infants and children

  5. Chronic or chronically-relapsing dermatitis

  6. Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of Atopic Dermatitis
  • older than 12 years old

排除标准

  • other specific forms of eczema such as contact eczema, seborrheic eczema, nummular eczema, occupational dermatitis, hand eczema
  • systemic diseases that can be accompanied by immunological skin abnormalities as psoriasis;
  • clinically significant chronic infectious disease(s) (eg, HIV, hepatitis B or C);
  • breastfeeding,pregnant/intending to become pregnant during study;
  • participation in any other clinical study;
  • part of the staff personnel involved with the study;
  • family member of investigational/study staff.

结局指标

主要结局

Score of severity of Atopic Dermatitis (SCORAD)

时间窗: 2 months

Investigator rated eczema severity: clinical improvement measured by local SCORAD (score of severity of AD)(initial versus final, % of change). SCORAD is composed of three different domains (A= extension B= intensity C = subjective symptoms)

Quality of life

时间窗: 2 months

Changes in Quality of life. Patients are asked to answer the Portuguese version of the Dermatology Life Quality Index (\> 16 years old) or the children´s Dermatology Quality of Life Index (4-16 years old) at the beginning and end of the study

次要结局

  • Immunological serum markers(2 months)
  • Need of eczema treatment(2 months)
  • Genetic mutations(2 months)
  • Participant rated symptoms of eczema(2 months)
  • Skin microflora(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Lopes

Cristina Lopes

Universidade do Porto

研究点 (1)

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