Evaluation of efficacy and safety of Dermatitis Lotion in the treatment of Atopic Dermatitis in Children: A prospective, single center, interventional study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Patient-Oriented Eczema Measure (POEM) score documented in the CRF baseline, day 30, day 60 and day 90
研究概览
简要总结
Dermatitis is also known as eczema, is group of diseases that can results in inflammation of skin. These diseases often characterized by dry, cracked skin, patches of red, scaly, and inflamed skin that may become itchy. There are several types of dermatitis and each type has distinct signs and symptoms. The most common form of dermatitis includes atopic dermatitis, contact dermatitis, dyshidrotic dermatitis, nummular dermatitis, seborrheic dermatitis, and statis dermatitis. Among these, atopic dermatitis (AD) is a most prevalent, and potentially debilitating condition that can affect quality of life (QoL). It is characterized by chronic inflammatory and relapsing pruritic skin lesions that generally begins in early childhood, usually between 3 and 6 months of age. Approximately 15% to 20% of children and 1% to 3% of adults affected worldwide and has 2- to 3-fold of increase in industrialized nations. Incidence of AD was about 28.46% in north Indian children registered to a paediatric dermatology clinic. The clinical features of AD includes pruritic, erythematous, weeping patches on the cheeks, scalp, and extensor surfaces of extremities. These lesions progress to xerosis, thickened plaques, papules, and excoriations on the wrists and flexural surfaces of extremities. There are a wide variety of pharmacological treatment strategies for prevention and management of dermatitis. But long-term use of pharmacological products results in development of adverse effects. The adverse effects associated with chronic use of current therapeutic agents promoted the use of nutraceuticals or herbal medicines as safety and commercial approaches for the prevention and management of dermatitis. Recently, the nutraceuticals have received substantial attention due to their potential nutritional values, safety, and therapeutic effects. Particularly, their active ingredients can have antioxidant activities and anti-inflammatory effects and have been used in the treatment of many diseases. Therefore, the aim of the current study is to determine the effect of dermatitis lotion for treatment and management of dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female children aged ≥ 6 months to ≤12 years.
- •Subject diagnosed with Atopic Dermatitis as per the medical judgement of the study investigator.
- •Subject with mild to severe eczema as determined by the Patient-Oriented Eczema Measure (POEM) score.
- •Children willing to provide informed assent if applicable.
- •Child’s parent/guardian/legally acceptable representative willing to provide informed written consent.
排除标准
- •Children with significant medical/surgical condition which requires long-term treatment.
- •Children with genetic diseases, congenital diseases and mentally challenged.
- •Children who are currently being treated with other atopic dermatitis drugs.
- •Allergy or sensitivity to any of the ingredients in the study treatment.
- •Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallely.
- •Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.
结局指标
主要结局
Patient-Oriented Eczema Measure (POEM) score documented in the CRF baseline, day 30, day 60 and day 90
时间窗: baseline, day 30, day 60 and day 90
次要结局
- Skin Tone, Skin Texture and Moisturisation of Atopic Dermatitis affected areas documented in the CRF baseline, day 30, day 60 and day 90(baseline, day 30, day 60 and day 90)