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临床试验/NCT03231813
NCT03231813已完成不适用

Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial

University of Split, School of Medicine1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年8月29日最近更新:
适应症
干预措施

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

Experimental

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

Experimental

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

Placebo Comparator

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 Comparator

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

No Intervention

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)

研究者

发起方
University of Split, School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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