Effect of Cream Paste Containg Pleuran (β-glucan From Pleurotus Ostreatus) on Selected Skin Dermatoses.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 15
- 主要终点
- Clinician's Erythema Assessment
研究概览
简要总结
In this multicentre, prospective clinical research conducted in outpatient healthcare facilities, the investigators studied the effect of novel cosmetic product Imunoglukan P4H® ACUTE! cream paste in children with neonatal pustulosis, diaper dermatitis or perioral dermatitis. The main endpoints of the study were focused on objective evaluation of erythema severity and overall improvement of selected dermatoses.
Participants enrolled in the study applied Imunoglukan P4H® ACUTE! cream paste at least 2-3 times daily (or as needed) in an adequate amount to the affected area for a maximum of 2 weeks (without other treatment).
详细描述
- Design: Multicentre, prospective, open-label study
- Centres: 20 outpatient healthcare facilities in Slovakia (1 Department of Dermatology, 19 general outpatient clinic for children and adolescents)
- Patients: 110 children from 3 weeks of age with selected skin dermatoses (neonatal pustulosis, diaper dermatitis, perioral dermatitis)
- Treatment: Imunoglukan P4H® ACUTE! cream paste applied 2-3 times a day or as needed (without other treatment)
- Study period: until erythema disappears or for a maximum of 14 days
- Primary endpoints:
- severity of erythema according to 5-point scale (Clinician's Erythema Assessment - CEA)
- overall severity and improvement of selected dermatoses according to 6-point scale (Investigator's Global Assessment - IGA)
- Secondary endpoint:
- tolerability of novel cosmetic product (Clinician's Assessment of Tolerability)
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
- 3 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •age from 3 weeks
- •at least one of the following diagnoses: perioral dermatitis, diaper dermatitis, neonatal pustulosis
排除标准
- •refused to sign informed consent
- •application of topical corticosteroids, antihistamines, other immunomodulatory preparations (e.g. beta-glucans) at time of inclusion
- •using of oral corticosteroids, antihistamines at time of inclusion
- •known intolerance to any ingredients contained in the investigational product
研究组 & 干预措施
Active group
干预措施: Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste (Other)
结局指标
主要结局
Clinician's Erythema Assessment
时间窗: from the enrolment (day 1;V0) to complete recovery from erythema (latest on day 14; V1) at each study visit Evaluations: - initial visit (V0) - day of enrolment - control visit (V1) - after complete recovery from erythema or max. 14 days from enrolment
Clinical assessment of erythema using a 5-point severity scale (0 = no erythema; 1 = very mild erythema: light pink; 2 = mild erythema: pink; 3 = moderate erythema: red; 4 = severe erythema: intense red)
Investigator's Global Assessment (IGA)
时间窗: from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1) initial visit (V0) - day of enrolment control visit (V1) - after complete recovery from erythema or maximum 14 days from enrolment
Overall severity and improvement of selected dermatoses (diaper dermatitis, perioral dermatitis, neonatal dermatitis) evaluated by Investigator's global assessment (IGA) using a 6-point scale (-1 = worsening; 0 = no response; 1 = mild response; 2 = moderate response; 3 = excellent response; 4 = complete response)
次要结局
- Incidence of Treatment-Emergent Adverse Events(from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1))
- Tolerability of the cosmetic product(from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1) Evaluation at control visit (V1) - after complete recovery from erythema or maximum 14 days from enrolment)