Testing the Effectiveness of an Intervention in Irritative Contact Dermatitis:Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- hydration measurement with corneometer probe
研究概览
简要总结
An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.
详细描述
An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system. Therefore, the aim of this study was to see if omega cream, as proposed by its mechanism of action, could improve SLS induced contact dermatitis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers who gave written informed consent
排除标准
- •· skin cancer
- •skin disease
- •skin damage on measurement sites
- •use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
- •use of drugs that may cause photosensitivity
- •use of emollients three days prior the inclusion in the trial
- •non-adherence to the trial protocol
- •exposure to artificial and excessive natural ultraviolet (UV) radiation
- •pregnancy and lactation
- •history of vitiligo, melasma and other pigmentation and photosensitivity disorders
- •immunosuppression
- •allergic or irritant reactions to the constituents of the cream
结局指标
主要结局
hydration measurement with corneometer probe
时间窗: through study completion, an average of 1 year
corneometer assessed stratum corneum hydration level
TEWL measurement with Khazaka probe
时间窗: through study completion, an average of 1 year
Transepidermal water loss
erythema measured with mexameter
时间窗: through study completion, an average of 1 year
mexameter assessed redness
次要结局
- clinical score according to dermatologist scale(through study completion, an average of 1 year)
研究者
Dario Leskur
assistant professor
University of Split, School of Medicine