NL-OMON54004已完成2 期
A Randomised, Double-Blind, Placebo-controlled, 32-week, Phase IIa trial to investigate the efficacy of OM-85 versus matched placebo in reducing disease severity in children aged 3 to 24 months with early clinical diagnosis of moderate atopic dermatitis - Immunomodulation by OM-85 in early AD
OM Pharma0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •1. Children of either gender, aged 3 to 24 months
- •2. Clinically confirmed diagnosis of AD of moderate severity documented by the
- •Investigator and lesions covering up to 30% of the body
- •3. AD onset no longer than 12 months before screening
- •4. Legally acceptable representatives (i.e. parent(s) or guardians) of subject
- •according to local regulations have provided the appropriate written
- •informed consent. Written informed consent must be provided before any
- •study-specific procedures are performed including Screening procedures.
排除标准
- •1. Any diseases that may be considered as the differential diagnosis of atopic
- •dermatitis, and notably skin infections and infestations (e.g. scabies), other
- •inflammatory skin conditions, dermatological malignancies, dermatological
- •genetic diseases such as immunodeficiency conditions, and nutritional disorders
- •with cutaneous manifestations and drug eruptions.
- •2. Specifically, any inflammatory skin conditions that are considered during
- •the differential diagnosis of atopic dermatitis: allergic contact dermatitis,
- •dermatographism, psoriasis, pityriasis alba.
- •3. Any chronic diseases (other than wheezing and asthmatic bronchitis) that
- •require the administration of systemic corticosteroids (e.g., eosinophilic
- •esophagitis) or immunosuppressant agents.
- •4. Significant medical condition(s), which, in the Investigator*s opinion, are
- •anticipated to require major surgery during the study, or any other type of
- •disorder that might involve an increased risk to the subject, could interfere
- •with study assessments or outcomes, or the ability of parents to comply with
- •the study procedures (e.g. eDiary).
- •5. Children with known allergy or previous intolerance/sensitivity to any of
- •the trial treatments (IMP, AxMP or standardized emollient) to be administered.
- •6. Use of systemic drugs interfering with the immune system (e.g.
- •corticosteroids, immunosuppressants) within 30 days before Baseline (with
- •exception of routine vaccinations)
- •7. Previous or ongoing treatment with other bacterial lysates and/or
- •probiotics within 30 days before Baseline
- •8. Use of systemic antibiotics within 30 days before Baseline
- •9. Participation in any other investigational trial on a medical device or
- •medicinal product < 30 days prior to Baseline or any previous participation in
- •a study involving bacterial lysates and/or probiotics, or current treatment
- •with other investigational agent(s)
- •10. Any major surgery within the last 3 months prior to Baseline, that in the
- •opinion of the Investigator, would not allow safe completion of the clinical
- •11. Subject's families expected to relocate out of study area during the
- •duration of the study.
- •12. Other household members have previously been randomised in this clinical
- •13. Previous participation to this study.
- •14. Close affiliation of subject or parents with the investigational site; e.g.
- •relative of the Investigator, dependent person (e.g. employee or student of the
- •investigational site)
研究者
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