Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change of transepidermal water loss (TEWL)
研究概览
简要总结
The objective of the study was to examine whether normalizing of the pH by acidification through topical treatment helps to strengthen the skin barrier, to induce epidermal differentiation and to reduce inflammation in healthy individuals.
详细描述
Previous studies have shown that an emollient adjusted to pH 4 has favorable effects to the skin of aged individuals. The objective of the study was to examine whether normalizing of the pH by acidification through topical treatment helps to strengthen the skin barrier, to induce epidermal differentiation and to reduce Inflammation. The effect of a cosmetic oil-in-water (O/W) emulsion adjusted to pH 4 in comparison to the same emulsion adjusted to pH 5.8 on the integrity of the skin barrier and the mechanical stability was examined in healthy volunteers from age 18 to 75 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The test areas were 5 x 5 cm squares on both inner (volar) forearms. The areas were randomized and double-blinded (regarding the two test products). For randomization, the permutated orthogonal Latin square method was used on condition that both test areas are always contralateral.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers (75 % women and 25 % men)
- •Aged 18 - 75 years
- •Healthy skin
- •Informed consent was given
排除标准
- •Atopic diathesis, atopic dermatitis and other skin diseases with a disrupted skin barrier
- •Dermatitis and other skin diseases in the test site
- •Birthmarks, tattoos, scars and other abnormalities in the test site, which may influence the measurements
- •Women: pregnancy and breastfeeding
- •Known contact sensitization
- •Severe systemic diseases
- •Regular use of sauna and solarium
- •Intensive UV exposure
- •Topical use of drugs in the test site four weeks before and during the study
- •Systemic administration of anti-inflammatory, immune-modulating and antibiotic drugs
- •Previous participation in other studies within the last month before the study
- •Alcohol and drug misuse
- •Missing awareness and inability to follow the instructions of the study staff
- •Other reasons which according to the study leader speak against the participation in the study
研究组 & 干预措施
No product use
Untreated control area
WO 5000
Body lotion pH 4 for topical application
干预措施: WO 5000 (Other)
WO 5001
Body lotion pH 5.8 for topical application
干预措施: WO 5001 (Other)
结局指标
主要结局
Change of transepidermal water loss (TEWL)
时间窗: Change from day 1 (before application) to day 30
Tewameter TM300, Courage \& Khazaka, Köln
Change of erythema
时间窗: Change from Day 1 to day 30 + 2 hours (after tape-stripping), measured over 3 timepoints (Day 1, day 30 and day 30 +2 hours (after tape stripping)
Visible score adapted from Frosch and Kligman: 0 = no redness, 0.5 = very slight redness, 1 = slight patchy or diffuse redness, 2 = moderate even redness, 3 = profound redness
Tape-stripping
时间窗: Day 31
Number of the tape-strips until a threefold increase in TEWL compared to unstripped baseline value is reached. (D-Squame® (DSQ), CuDerm Corporation, Dallas)
Corneocyte size
时间窗: Day 31
After staining with Nile Red by immunofluorescence microscopy and digital imaging
Amount of the cytokine IL-1α
时间窗: Day 31
Determined by enzyme-linked immunosorbent assay (ELISA)
Change of skin hydration
时间窗: Change from day 1 (before application) to day 30
Corneometer CM 825, Courage \& Khazaka, Köln
Change of pH
时间窗: Change from Baseline to day 31, measured over 5 time points (Day 1, day 30, day 30+3 hours, day 30+6 hours and day 31)
pH-Meter 910, Courage \& Khazaka, Köln
Amount of antimicrobial peptide hBD-2
时间窗: Day 31
Determined by enzyme-linked immunosorbent assay (ELISA)
次要结局
未报告次要终点