Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Transepidermal water loss
研究概览
简要总结
Irritant contact dermatitis induced by sodium lauryl sulphate (SLS) is often used as a model for testing efficacy of various topical preparations. Aforementioned model is standardized and described in guidelines, but it is not explicitly stated where the irritation should be induced. Published clinical trials usually irritate volar aspect of forearms or upper back. Also, lower back and dorsal aspect of forearm are sometimes used.
Skin parameters vary depending on anatomic location of measured skin. There is a difference in stratum corneum thickness, hydration and transepidermal water loss across different locations, including between volar forearm and upper back.
Furthermore, regional difference in skin response to irritation by tape stripping and benzalkonium chloride were observed. Such differences are also possible in SLS irritation model. One study has shown higher, but not statistically significant, response of back in comparison to forearms, but it had a very small sample size (n=9).
Moreover, there are regional variations of topical preparations absorption. Hydrocortisone had 1,7 times higher absorption when applied to upper back in comparison to forearms. Those variations could be explained by different corneocyte size and number of their layers between back and hands.
Skin baseline properties and response to irritation seem to be dependent on anatomic position. Those differences could mean different response to treatment. Since published trials only tested efficacy of various preparations on one anatomic location, it is possible their results would be different if tested on other body parts. It could limit validity and usefulness of conducted trials. The aim of this study is to determine if there are regional differences of skin response to irritation and emollient cream treatment in irritant contact dermatitis model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •young, healthy volunteers who gave written informed consent
排除标准
- •skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior the inclusion and during the trial, use of emollients three days prior the inclusion in the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation
研究组 & 干预措施
SLS irritation model and Treatment
SLS induced irritation on two sites each on forearms and back Emollient cream treatment
干预措施: Sodium lauryl sulphate induced irritation (Procedure)
SLS irritation model and Treatment
SLS induced irritation on two sites each on forearms and back Emollient cream treatment
干预措施: Emollient, moisturizing cream (Other)
SLS irritation model and No Treatment
SLS induced irritation on two sites each on forearms and back No treatment
干预措施: Sodium lauryl sulphate induced irritation (Procedure)
Sham irritation and Treatment
Sham irritation (water) on two sites each on forearms and back Emollient cream treatment
干预措施: Emollient, moisturizing cream (Other)
Sham irritation and No Treatment
Sham irritation (water) on two sites each on forearms and back No treatment
结局指标
主要结局
Transepidermal water loss
时间窗: Five measurements; baseline, irritation, first, third and ninth day of treatment
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
Stratum corneum hydration
时间窗: Five measurements; baseline, irritation, first, third and ninth day of treatment
Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
Erythema
时间窗: Five measurements; baseline, irritation, first, third and ninth day of treatment
Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).
次要结局
- Clinical score(Five assessments: baseline, irritation, first, third and ninth day of treatment)
