Comparison of Efficacy and Safety Between Moisturising Cream Containing 12% Ammonium Lactate AND 10% Urea in Geriatric With Xerosis Cutis: Double Blind Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- First Evaluation of Specified Symptom Sum Score (SRRC)
研究概览
简要总结
This study aims to compare the efficacy and safety between moisturizing cream containing 12% ammonium lactate and 10% urea in geriatric with xerosis cutis. A double-blind randomized controlled trial with matching paired subject was conducted on 40 residents of a nursing home in Jakarta. Specified symptom sum score (SRRC), skin capacitance (SCap), transepidermal water loss (TEWL), and side effects were measured at baseline, week-2 and week-4 after therapy, and week-5 one week after therapy cessation. After a week of preconditioning, each subject received two different moisturizing creams to be applied on separate lower limbs.
详细描述
Dry skin or xerosis cutis is widely known skin health issue in geriatric population with prevalence rate ranges between 29.5 - 85.5%. One of the internal etiological factors is decreased production of natural moisturizing factor as a humectant. Application of moisturizer is the mainstay treatment. Moisturizer with humectant property, like lactate and urea, could restore skin hydration and barrier dysfunction. This study aims to compare the efficacy and safety between moisturizing cream containing 12% ammonium lactate and 10% urea in geriatric with xerosis cutis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
same vehicle base ingredients, colour, smell, and packaging
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presenting with clinical diagnosis of xerosis cutis or with using the specified symptom sum score (SRRC)
- •able to communicate well and perform daily activities independently
- •willing to follow the research and sign the informed consent
排除标准
- •sensitive to the ingredients in the formulations
- •suffer from dermatitis or skin inflammation at the test site
- •erythema and fissure values based on SRRC value >2
研究组 & 干预措施
12% AMMONIUM LACTATE
Matching paired subject was conducted on 40 residents. Test subject received two different randomized moisturizing creams to be applied on two separate locations on the lower limbs twice a day for 4 weeks. One of the moisturising cream contained active ingredient 12% ammonium lactate. The evaluation of specified symptom sum score (SRRC), skin capacitance (SCap), transepidermal water loss (TEWL), and side effects were measured at baseline, week-2 and week-4 after therapy, and week-5 one week after therapy cessation.
干预措施: Ammonium Lactate (Drug)
10% UREA
Matching paired subject was conducted on 40 residents. Test subject received two different randomized moisturizing creams to be applied on two separate locations on the lower limbs twice a day for 4 weeks. One of the moisturising cream contained active ingredient 10% urea. The evaluation of specified symptom sum score (SRRC), skin capacitance (SCap), transepidermal water loss (TEWL), and side effects were measured at baseline, week-2 and week-4 after therapy, and week-5 one week after therapy cessation.
干预措施: Urea (Drug)
结局指标
主要结局
First Evaluation of Specified Symptom Sum Score (SRRC)
时间窗: initial visit (day 1)
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed before therapy.
Second Evaluation of Specified Symptom Sum Score (SRRC)
时间窗: Change of SSRC at day 15 from initial visit
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy.
Third Evaluation of Specified Symptom Sum Score (SRRC)
时间窗: Change of SSRC at day 29 from initial visit
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy.
Fourth Evaluation of Specified Symptom Sum Score (SRRC)
时间窗: Change of SSRC at day 36
System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed after 1 week of therapy discontinuation
First Evaluation of Skin Capacitance (SCap)
时间窗: Performed at initial visit (day-1)
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed before therapy.
Second Evaluation of Skin Capacitance (SCap)
时间窗: Change of SCap at day-15
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.
Third Evaluation of Skin Capacitance (SCap)
时间窗: Change of SCap at day-29
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.
Fourth Evaluation of Skin Capacitance (SCap)
时间窗: Change of SCap at day-36
Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed after 1 week of therapy discontinuation
First Evaluation of Transepidermal Water Loss (TEWL)
时间窗: Performed at initial visit (day-1)
Assess the skin barrier homeostasis condition using Tewameter® TM300 before therapy.
Second Evaluation of Transepidermal Water Loss (TEWL)
时间窗: Change of TEWL at day-15 from initial visit
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.
Third Evaluation of Transepidermal Water Loss (TEWL)
时间窗: Change of TEWL at day-29 from initial visit
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.
Fourth Evaluation of Transepidermal Water Loss (TEWL)
时间窗: Change of TEWL at day-36 from initial visit
Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed after 1 week of therapy discontinuation.
First Side Effect Evaluation
时间窗: Performed at 2 weeks after therapy (day-15)
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.
Second Side Effect Evaluation
时间窗: Performed at day-29 (4 weeks after therapy)
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.
Third Side Effect Evaluation
时间窗: Performed at day-36 (5 weeks after therapy)
Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging. Performed after 1 week of therapy discontinuation
次要结局
未报告次要终点
研究者
Eyleny Meisyah Fitri
Principal Investigator
Indonesia University