Clinical Trial Study for Evaluation of A-1 Cool Cream Efficacy for Treatment Patients With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- Evaluation of A-1 cool treatment by TIS score
研究概览
简要总结
Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 20% of all babies and children around the world. Diagnosis of atopic dermatitis is clinical and depends on the existence of at least two out of the four following criteria: itching, a chronic disease course with exacerbations and remission ,rash with characteristic distribution and shape , atopia of the patient or family by history.
Initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and allergens. The research product A-1 COOL is a skin cream approved by the Israeli Ministry of Health for cooling down of skin irritation. A-1 COOL is rich in herbal medicine ingredients and does not contain steroids.A-1 COOL can be beneficial in Atopic Dermatitis patients due to its following action mechanisms: sealing of the inflamed skin and retention of water, prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the herbal ingredients.
详细描述
Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 20% of all babies and children around the world. In 90% of the cases the disease first appears before the age of five and in 65% of the cases it is already apparent at infancy but it may occur at any age.
Diagnosis of atopic dermatitis is clinical and depends on the existence of at least two out of the four following criteria: itching, a chronic disease course with exacerbations and remission ,rash with characteristic distribution and shape , atopia of the patient or family by history.
Initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and allergens. Topical ointments which grease the skin have shown and reduction of skin inflammation. These products can include active substances such as steroids and anti-inflammatory compounds.
Systemic treatments for atopic dermatitis mainly include steroids and cyclosporine.
The research product A-1 COOL is a skin cream approved by the Israeli Ministry of Health for cooling down of skin irritation. A-1 COOL is rich in herbal medicine ingredients and does not contain steroids.A-1 COOL can be beneficial in Atopic Dermatitis patients due to its following action mechanisms: sealing of the inflamed skin and retention of water, prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the herbal ingredients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with atopic dermatitis,
- •Hebrew-speaking men and women,
- •over 18 years old.
排除标准
- •hospital where the diagnosis of atopic dermatitis is not sure,
- •patients under the age of 18, pregnant women, no - helpless, soldiers and prisoners,
- •patients with atopic dermatitis treated with systemic preparations such as cyclosporine, steroids, antibiotics, methotrexate, biological preparations.
研究组 & 干预措施
A-1 COOL cream
A research product - A-1 COOL cream contain herbal medicine plants basically :
- WATER PETROLATUM
- WILD YAM (DIOSCOREA VILLOSA) EXTRACT
- SORBITAN SESQUIOLEATE
- CALENDULA OFFICINALIS EXTRACT
- MINERAL OIL
- ARNICA MONTANA EXTRACT
- MICROCRYSTALLINE WAX
- LICORICE (GLYCYRRHIZA GLABRA) EXTRACT
- DECYL OLEATE
- DICOCOYL PENTAERYTHRITYL DISTEARYL CITRATE
- BEESWAX
- ALUMINUM STEARATES
干预措施: A -1 Cool Cream,Vaselin ointment (Drug)
Vaselin ointment
Using the study as placebo.
干预措施: A -1 Cool Cream,Vaselin ointment (Drug)
结局指标
主要结局
Evaluation of A-1 cool treatment by TIS score
时间窗: 5 DAYS
Initially, we will evaluate the disease severity in all the research subjects by SCORAD SCORE and TIS score.Thereafter we will apply to each subject's flexor aspects of the upper or lower limbs on one side the research product and on the other the placebo.This treatment will be given twice a day at specific times for 5 days. As ameasure to evaluate the efficacy of A-1 COOL treatment wiil be use the Three- item severity score (TIS)- reviewer redness, edema ,scratch marks.Severity of these symptoms wiil be evaluated from 0 to 3 points scale.
次要结局
未报告次要终点