Frequency of Palpebral Involvement in Adult Atopic Dermatitis, in a Cohort of Patients From Lille and Rouen (France) ; a Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease
研究概览
简要总结
Atopic dermatitis is a common inflammatory skin disease, resulting from genetical, immunological and environmental factors. Head and neck are among the most frequent involved areas, almost 50% in adult patients according to most publications. Palpebral involvement is also common and a source of major quality of life impairment for patients.
However, the real frequency of this palpebral involvement is unknown, only estimated about 20% in few studies. The treatment of this location remains difficult, regarding to the thickness of palpebral skin and proximity of the eye.
To our knowledge, no prospective studies about allergological skin tests (such as patch-tests) in atopic patients with palpebral involvement had been conducted.
Finally, atopic dermatitis is frequently associated with ophthalmological diseases such as conjunctivitis, keratoconus or cataract, which belong to the minor criteria of Hanifin and Rakja classification.
A better knowledge of the atopic dermatitis palpebral involvement and the associated factors seems to be needed to improve the treatment and the quality of life of patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Atopic Dermatitis according to the revised Hanifin and Rakja criteria (UK Working Party)
- •Oral consent
- •Valid social insurance
排除标准
- •Personal history of uncontrolled asthma
- •No social insurance
- •Protective measures
- •Age under 18
- •Pregnancy or breast-feeding
结局指标
主要结局
Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease
时间窗: At Baseline, the initial consultation of dermatology
次要结局
- Clinical description of the palpebral involvement : acute eczema or chronic eczema(At Baseline, the initial consultation of dermatology)
- Rate of relevant contact sensitization according to the skin testing and the clinical manifestations(At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours)
- Rate of ophthalmologic comorbidities in association with palpebral involvement of the atopic dermatitis(At 3 months during the time of the ophthalmologic consultation)
- Clinical description of the ophthalmologic involvement and OSDI scoring(At 3 months during the time of the ophthalmologic consultation)
- Association between ophthalmologic involvement and severity of the atopic dermatitis(At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours)
- Potential factors associated with palpebral involvement of the atopic dermatitis (socio-demographics factors, clinical factors, comorbidities, treatment, severity …)(At Baseline, (the initial consultation of dermatology ) and at 3 months during the consultation of allergology)
- Description of the sensitization profile(At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours)
- Association between allergic sensitization and severity of the atopic dermatitis(At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours)
- Association between allergic sensitization and ophthalmologic involvement(At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours)