Effectiveness and Safety Comparison Between Moisturizers Containing Low Molecular Weight Hyaluronic Acid, High Molecular Weight Hyaluronic Acid, and Vehicle on Skin Hydration in the Elderly With Xerotic Skin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Skin capacitance
研究概览
简要总结
The goal of this clinical trial is to compare 0,1% topical low molecular weight (7 kDa) hyaluronic acid with 0,1% high molecular weight (1.800 kDa) hyaluronic acid as therapy of xerotic skin in elderly
详细描述
This clinical trial is conducted to compare the effectiveness and safety between moisturizers containing 0,1% low molecular weight hyaluronic acid, 0,1% high molecular weight hyaluronic acid, and its vehicle on skin hydration of elderly with xerotic skin. It is designed to answer following questions:
- Is the skin capacitance in the elderly after using moisturizers containing low molecular weight hyaluronic acid higher than high molecular weight hyaluronate acid and vehicle?
- Is the transepidermal water loss in the elderly after using moisturizers containing high molecular weight hyaluronic acid lower than low molecular weight hyaluronate acid and vehicle?
- Is the dry skin score (SRRC) in the elderly after using moisturizers containing low molecular weight hyaluronic acid lower than high molecular weight hyaluronate acid and vehicle?
- Is there any difference in occurence of side effect in elderly between the use of moisturizers containing low molecular weight hyaluronic acid, high molecular weight hyaluronic acid, and vehicle?
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)
盲法说明
All moisturizers used in this clinical trial were made in the same preparation and packaging
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male diagnosed with xerotic skin
- •60-80 years old
- •Willing to participate in clinical trial and sign informed consent
排除标准
- •History of hypersensitivity to moisturizer
- •Dermatitis or any dermatosis on intervention area in the leg
- •Score of erythema and crack more than 2, based on SRRC scoring
研究组 & 干预措施
Topical 0,1% low molecular weight (7 kDa) hyaluronic acid
Participants receive moisturizer containing 0,1% low molecular weight (7 kDa) hyaluronic acid on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month
干预措施: Low molecular weight hyaluronic acid (Drug)
Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid
Participants receive moisturizer containing 0,1% high molecular weight (1.800 kDa) hyaluronic acid on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month
干预措施: High molecular weight hyaluronic acid (Drug)
Vehicle
Participants receive vehicle on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month.
干预措施: Vehicle (Drug)
结局指标
主要结局
Skin capacitance
时间窗: 2 weeks and 4 weeks
Skin capacitance is measured by Corneometer CM825
Specified symptom sum score/scale, roughness, redness, crack (SRRC)
时间窗: 2 weeks and 4 weeks
Evaluation of squama/scale, roughness, redness, and crack of the skin, with a value range of 0-16. Higher values mean worse outcome
Transepidermal water loss
时间窗: 2 weeks and 4 weeks
Transepidermal water loss is measured by Tewameter TM300
次要结局
未报告次要终点
研究者
Parikesit Muhammad
Dermatology and Venereology Resident
Indonesia University