Comparison of Efficacy and Safety Profile Between Moisturizers Containing a Combination of 5% Hydro-Urea, Ceramide, With MultiVesicular Emulsion Technology and Petrolatum on Dry Skin in the Elderly: A Randomized, Controlled, Double-Blind Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in SRRC
研究概览
简要总结
This study investigated the efficacy and safety of a moisturizer containing 5% hydro-urea, ceramide, and MVE technology compared with petrolatum for dry skin in the elderly.
详细描述
This study was a double-blind, randomized controlled trial was conducted on 48 elderly population of a nursing home in Jakarta. The participants, aged 60 years and older, had been diagnosed with dry skin. Each subject was randomly assigned to receive one of two moisturizers (either a formulation containing 5% hydro-urea and ceramides with MVE technology, or petrolatum) for topical application to both lower legs. 5-D pruritus scale, dermatology life quality index (DLQI), specified symptom sum score (SRRC), transepidermal water loss (TEWL), and skin capacitance (SCap) were measured at day 0, 7, 28, and three days post-treatment cessation (day 31).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals aged 60 years or older who have been diagnosed with clinically dry skin (indicated by SRRC score ranging from 5 to 16), have not used topical moisturizers for at least 2 weeks and oral moisturizing supplements for at least 4 weeks prior, willingness to comply with the research procedures, able to communicate well, and provide written consent by signing the informed consent from.
排除标准
- •individuals with a previous record of hypersensitivity to the moisturizer, dermatitis, or other skin disease affecting the lower extremities, and those with an erythema/fissure score greater than 2 based on SRRC.
研究组 & 干预措施
Petrolatum
Petrolatum twice a day
干预措施: Petrolatum Ointment (Drug)
结局指标
主要结局
Change in SRRC
时间窗: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Specified symptom sum score. Measuring dry skin using four variables (scale, roughness, redness, and cracking) in score ranged from 1 to 4 for each variable. The highest the value marks the driest skin
Change in Skin Capacitance
时间窗: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
SCap measured in (AU)
Change in TEWL
时间窗: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
Transepidermal water loss reflects the amount of water lost through evaporation
Change in 5-D Pruritus Scale
时间窗: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
This multidimensional questionnaire is used to measure itch intensity. The 5-D scale evaluates five domains of itch: duration, degree, direction, disability, and distribution. The total scores range from 5 to 25.
Change in Dermatology Life Quality Index
时间窗: Baseline (Day 0), Day 7, Day 28, and Day 31 (3 days post-treatment cessation).
The Dermatology Life Quality Index (DLQI) questionnaire is used to measure the impact of xerosis cutis on the subject's quality of life. The questionnaire evaluates symptoms, daily activities, leisure, work, personal relationships, and treatments. The total scores range from 0 to 30
Adverse Events
时间窗: Assessed throughout the 31-day observation period
Assessment of safety and tolerability by evaluating the occurrence of subjective side effects (including itching, discomfort, and stinging) and objective side effects (including contact dermatitis and folliculitis) following the application of the moisturizers.
次要结局
未报告次要终点
研究者
Dr. dr. Lili Legiawati, SpKK(K)
Principal Investigator
Indonesia University