Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline of skin erythema index
研究概览
简要总结
Open clinical study to evaluate the soothing and re-epithelizing activity of a single application of two cometic formulations ("P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO") on experimentally induced erythema by repeated tape stripping on the forearm (volar surface) of 20 healthy volunteers.
Study products activity was assessed in comparison to placebo ("P926P - LICHTENA DermAD CREMA VISO - PLACEBO") and versus untreated control area.
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
- •Volunteers of both sexes
- •TEWL value on tested skin areas immediately after tape stripping >15g/m2-h
- •volunteers in a good general state of health in the Investigator opinion
- •volunteers not taking drugs or undergoing surgical procedure
- •volunteers who are giving a written informed consent.
排除标准
- •Pregnancy (only for female subjects)
- •lactation (only for female subjects)
- •TEWL value on tested skin areas immediately after tape stripping <15g/m2-h
- •change in the normal habits in the last month
- •participation in a similar study during the previous month
- •known allergy to one or several ingredients of the products on trial.
- •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
LICHTENA DermAD
Comparison within subjects of "P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO" versus placebo and versus untreated control area. Study products were applied once, on experimentally induced erythema by repeated tape stripping on 4 different adjacent skin areas of the forearms (volar surface - 2 areas on each side)
干预措施: P926 - LICHTENA DermAD CREMA VISO (Other)
LICHTENA DermAD
Comparison within subjects of "P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO" versus placebo and versus untreated control area. Study products were applied once, on experimentally induced erythema by repeated tape stripping on 4 different adjacent skin areas of the forearms (volar surface - 2 areas on each side)
干预措施: P927 - LICHTENA DermAD CREMA CORPO (Other)
LICHTENA DermAD
Comparison within subjects of "P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO" versus placebo and versus untreated control area. Study products were applied once, on experimentally induced erythema by repeated tape stripping on 4 different adjacent skin areas of the forearms (volar surface - 2 areas on each side)
干预措施: P926 - LICHTENA DermAD CREMA VISO - PLACEBO (Other)
LICHTENA DermAD
Comparison within subjects of "P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO" versus placebo and versus untreated control area. Study products were applied once, on experimentally induced erythema by repeated tape stripping on 4 different adjacent skin areas of the forearms (volar surface - 2 areas on each side)
干预措施: Untreated control area (Other)
结局指标
主要结局
Change from baseline of skin erythema index
时间窗: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404)
Change from baseline of skin redness
时间窗: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
The instrumental measurement of skin redness is performed by the use of an optical colorimetry (Chroma Meter CR-200®)
Change from baseline of Transepidermal water loss (TEWL)
时间窗: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
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 hour (T1h), 24 hours (T24h)
Skin electrical capacitance value is measured with Corneometer CM825
Change from baseline of deep skin hydration
时间窗: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
Change from baseline of Epicutaneous pH
时间窗: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Surface cutaneous pH is measured with pH meter HI5221
Change from baseline of Surface microrelief's regularity
时间窗: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable
次要结局
未报告次要终点