An Open-Labeled Exploratory Study to Evaluate the Application of Natural Lactic Acid-enriched Cream in Adults With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- EASI
研究概览
简要总结
Atopic dermatitis (AD) is the most common chronic inflammatory skin disorder, with a lifetime prevalence of 15-25% in children and 1-3% in adults worldwide. AD is a heterogeneous disease induced by multiple factors, including genetic mutation and environmental risk factors. The main inflammatory mechanism that contributed to AD is the immune response mediated by T helper 2 (Th2) cells. The clinical features of AD, such as recurrent eczematous lesions, IgE-mediated intense itch, and the disruption of skin barrier induced by abnormal epidermal cell differentiation and protein structures, etc., can be attributed to the secretion of Th2 cell-related cytokines. AD is likely to be a lifelong illness with repeated onsets, causing not only physiological discomfort but also psychological distress; hence the quality of life of AD patients is inevitably affected.
Lactic acid is a natural moisturizing factor, which exists in healthy skin. It can efficiently prevent water loss from the skin and alleviate allergic reactions caused by dry skin. The moisturized function of lactic acid has made it became a commonly used additive in a wide variety of skincare products, such as lotion, cream, butter and spray. This product is rich in natural lactic acid generated by the fermentation of probiotics, and therefore can relieve skin itching caused by skin dryness, and resume the water-holding capability of the skin by removing abnormally proliferative stratum corneum as well as inducing collagen production. Importantly, this product is a steroid-free product with safety and without any induced adverse effects in use. This product is also can be a promising option other than steroids to be applied for the mitigation of recurrent symptoms in atopic dermatitis by resuming the water-retention ability of skin and rebuilding skin barrier function.
详细描述
I. Study Purpose
- Hypothesis:
Natural lactic acid-enriched cream improves the Eczema Area and Severity Index scores in AD patients through inhibiting S. aureus colonization.
- Primary Objective: The primary objective of this study is to assess the clinical efficacy of natural lactic acid-enriched cream for the improvement of Eczema Area and Severity Index (EASI) score in patients with atopic dermatitis.
- Secondary Objectives:
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is male or female between 12 and 65 years of age.
- •The subject has a physician-confirmed diagnosis of chronic atopic dermatitis according to Hanifin and Rajka criteria and having active inflammation.
- •Body surface area (BSA) involvement between 10% and 20%, excluding scalp, at baseline.
- •An IGA of atopic dermatitis score of 3 at baseline.
- •At least one target lesion that measure at least 3 centimeter (cm) x 3 cm in size at Screening and Baseline and must be representative of the subject's disease state, but not located on the hands, feet, or genitalia.
排除标准
- •Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to Baseline.
- •Used any of the following treatments within the indicated washout period before the baseline visit: 12 weeks or 5 half-lives (whichever is longer) - biologic agents (eg, 18 weeks for omalizumab); 8 weeks - cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus); 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs; 1 weeks - topical treatments: corticosteroids, calcineurin inhibitors, or coal tar (on the body); 2 weeks - sedating antihistamines (non sedating antihistamines are permitted); 1 week - topical antibiotics, antibacterial cleansing body wash/soap or diluted sodium hypochlorite "bleach" baths.
- •Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 4 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the subject's atopic dermatitis.
- •The subject planned or anticipated use of any prohibited medications and procedures during study treatment.
- •Active bacterial, viral, or fungal skin infections.
- •Participants with any systemic disorder, active skin disease or subjects who present with scars, moles, tattoos, sunburn in the test area which could interfere with the assessment of lesions at screening.
- •Participant who is immunocompromised (e.g. history of lymphoma, Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS), Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non- melanoma skin cancer).
- •Participants with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
- •Subjects have an allergic history of soybean and soybean-derivatives.
- •Pregnant or lactating females, or females who desire to become pregnant and/or breast feed within the duration of study participation.
- •The subject planned or anticipated major surgical procedure during the patient's participation in this study.
结局指标
主要结局
EASI
时间窗: Week 12
The mean change from baseline in EASI at week 12.
次要结局
未报告次要终点