Prospective, Randomized Study on the Skin Functional Parameters to Assess Skin Barrier Improvement After the Use of a Commercially Available Oil Bath Containing 84.75% Soybean Oil Compared to no Bath Additive
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
研究概览
简要总结
Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be compromised. Skin care practices to decrease the risk of development of dry skin and/or to improve dry skin condition have barely been investigated. Bathing with bath oils has been shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore, the aim of this study is to investigate the effect of bathing every other day on the skin barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH (pH) were measured to characterize skin barrier function.
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
- None
入排标准
- 年龄范围
- 6 Months 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study
- •Child specific written informed consent, if over 7 years of age
- •Subjects with a general good and stable health condition
- •Subjects with clinically stable medical conditions
- •Accept to abstain from sunbathing and solarium during the study
- •Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs
- •TEWL > 12 g/m2/h on the left mid volar forearm
排除标准
- •Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars
- •Suffering from porphyria
- •Suffering from severe photodermatoses according to the judgment of the investigator
- •Clinically significant, possibly unstable medical conditions such as metastatic tumor
- •Currently having other malignant or benign tumors of the skin in the investigational area
- •Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion
- •Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol
- •Use of (medical) oil-containing bath additives or other oil-containing cleansers
- •Current topical or systemic treatment affecting the skin, e.g. diuretics
- •Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before inclusion
- •Systemic immunosuppressive or immunomodulatory therapy
- •Topical retinoids applied during the 6 weeks before inclusion
- •Topical application of immunosuppressive treatment during the 6 weeks before inclusion
- •Therapeutic UV-Radiation during the 6 weeks before inclusion
- •Increased UV-exposure during the 6 weeks before inclusion
结局指标
主要结局
Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm
时间窗: Day 28 +/- 3
TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm. Visit 3 (day 28) - end of study visit
次要结局
- Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg(Day 28 +/- 3)
- Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm(Day 14 +/- 2)
- Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg(Day 28 +/- 3)
- Skin Surface pH at the Right Lateral Lower Leg(Day 28 +/- 3)
- Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg(Day 28 +/- 3)
- Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg(Day 28 +/- 3)
- Overall Dry Skin (ODS) Score at the Left Lower Leg(Day 28 +/- 3)
- Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm(Day 28 +/- 3)
- Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm(Day 28 +/- 3)
- Overall Dry Skin (ODS) Score at the Left Arm(Day 28 +/- 3)
- Overall Dry Skin (ODS) Score at the Right Arm(Day 28 +/- 3)
- Overall Dry Skin (ODS) Score at the Right Lower Leg(Day 28 +/- 3)
- Overall Dry Skin (ODS) Score at the Trunk(Day 28 +/- 3)
- Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm(Day 28 +/- 3)
- Skin Surface pH at the Left Midvolar Forearm(Day 28 +/- 3)
研究者
PD Dr. Jan Kottner
Scientific Director Clinical Research Center for Hair and Skin Science
Charite University, Berlin, Germany