Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change from baseline of Transepidermal water loss (TEWL)
研究概览
简要总结
Open clinical study to evaluate the soothing activity of a body cream to be applied once a day, mono-laterally at level of the antecubital fold and forearm, for an uninterrupted period of 1 month, by 22 adult volunteers, with positive anamnesis for atopy and habitual itching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult volunteers of both sexes
- •volunteers with positive anamnesis for atopy and habitual itching
- •volunteers in a good general state of health in the Investigator opinion
- •negative pregnancy test (only for female subjects not in menopause)
- •accepting to follow the instructions received by the investigator
- •accepting to not change their habits regarding food, physical activity, body cleansing
- •agreeing not to apply or take any product/drug or use body massages able to change skin conditions during the entire duration of the study
- •accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study
- •no participation in a similar study currently or during the previous 3 months
- •volunteers who are giving a written informed consent.
排除标准
- •Pregnancy (only for female subjects not in menopause)
- •lactation (only for female subjects not in menopause)
- •change in the normal habits in the last month
- •participation in a similar study during the previous 3 months
- •known allergy to one or several ingredients of the product on trial
- •insufficient adhesion to the study protocol
- •Dermatitis
- •presence of cutaneous disease on the tested area, as lesions, scars, malformations
- •clinical and significant skin condition on the test area.
- •endocrine disease
- •hepatic disorder
- •renal disorder
- •cardiac disorder
- •pulmonary disease
- •neurological or psychological disease
- •inflammatory/immunosuppressive disease
- •drug allergy.
- •Anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago)
- •using of drugs able to influence the test results in the investigator opinion.
研究组 & 干预措施
P927 - LICHTENA DermAD CREMA CORPO
Application of the product under study mono-laterally at level of the forearm, including the antecubital fold, on the right or left side according to a randomization list defined by the investigator.
干预措施: P927 - LICHTENA DermAD CREMA CORPO (Other)
结局指标
主要结局
Change from baseline of Transepidermal water loss (TEWL)
时间窗: Baseline (T0), 1 month (T1), 2 months (T2)
The measurement of TEWL, performed by the use of Tewameter® TM300, allows to objectively monitor skin responses to cosmetic treatments. A shift from low-normal rates of TEWL to high levels is due to barrier disruption.
Change from baseline of Superficial skin hydration
时间窗: Baseline (T0), 1 month (T1), 2 months (T2)
Skin electrical capacitance value is measured with Corneometer CM825
Change from baseline of Deep skin hydration
时间窗: Baseline (T0), 1 month (T1), 2 months (T2)
Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
Change from baseline of Surface microrelief's regularity
时间窗: Baseline (T0), 1 month (T1), 2 months (T2)
Surface microrelief's regularity is performed on skin replicas images acquired by Primos
Change from baseline of Epicutaneous pH
时间窗: Baseline (T0), 1 month (T1), 2 months (T2)
Surface cutaneous pH is measured with pH meter HI5221
次要结局
- Change from baseline of itching sensation(Baseline (T0), 1 month (T1), 2 months (T2))