CTRI/2025/12/099585尚未招募不适用
Development and Validation of BIOMOIST- Moisturizer from Aleovera Added with Probiotics.
Saveetha medical college hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in pruritus score
研究概览
简要总结
This prospective, open-label pilot study aims to develop and validate a novel Aloe vera–based moisturizer enriched with probiotics (BIOMOIST) for the management of pediatric dermatitis. Children aged 6 months to 5 years with mild to moderate dermatitis will receive topical application of the formulation. Outcomes will include improvement in pruritus, skin condition scores, sleep quality, and caregiver satisfaction. The study seeks to evaluate safety, feasibility, and preliminary efficacy of the formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 6 months and 5 years with a clinical diagnosis of dermatitis considered suitable for topical therapy were eligible for inclusion.
- •Only patients with limited disease involvement, defined as target lesions affecting not more than 10 percent of the total body surface area, were enrolled.
- •Lesions were required to be located on the trunk or extremities.
- •Written informed consent was obtained from the parent or legal guardian prior to inclusion in the study.
排除标准
- •Children with a known history of hypersensitivity to Aloe vera, probiotics, or any of the formulation excipients were excluded.
- •Patients presenting with infected, ulcerated, or actively weeping skin lesions were not considered for enrolment.
- •Those with severe chronic dermatological conditions requiring systemic therapy, as well as children receiving systemic corticosteroids or other immunosuppressive medications, were also excluded from the study.
结局指标
主要结局
Reduction in pruritus score
时间窗: baseline and after 4 weeks
Improvement in skin condition score (SCORAD)
时间窗: baseline and after 4 weeks
次要结局
- Improvement in sleep quality,(Caregiver satisfaction,)
研究者
Dr Akash
Saveetha medical college hospital
研究点 (1)
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