Pierre Fabre Dermo-cosmétique, Centre R&D Pierre Fabre, Innovation et Développement Pharmacologie, Toulouse, France.
Luxembourg Institute of Science and Technology (LIST), Advanced Characterization platform, Materials Research and Technology, Belvaux, Luxembourg.
J Eur Acad Dermatol Venereol. 2022 Apr;36 Suppl 5:21-29. doi: 10.1111/jdv.17900.
We have developed innovative base formulations that were designed to mimic the skin with respect to its components and galenic structure. Components include water, proteins, lipids, sugars and minerals.
We characterized formulations and their skin penetration using in vitro methods and evaluated their impact on skin hydration in a clinical trial.
Scanning electron microscopy (SEM) imaging and X-ray diffraction were used to analyse formulations as well as formulation impact on the stratum corneum (SC) structure. Mass spectrometry imaging (MSI) was used to compare formulation ingredients with SC components and to detect their distribution in the skin. Clinical studies were performed to confirm effects on skin hydration and investigate potential adverse skin effects (irritation and sensitization).
SEM and X-ray diffraction of the formulations showed that lipids were organized in sheets similar to SC lipids. MSI demonstrated similarities between formulation components and skin constituents, as well as a good penetration into the skin. The formulations did not modify the lamellar organization of the SC lipids, but they increased the relative proportion of the crystallized lipids and some of the amorphous lipids. In in vivo studies, a high level of hydration was maintained over 24 h after application with an intense and 'very good hydration'. Both formulations were shown to be non-(photo)sensitizers with excellent tolerance. Sensorial evaluation indicated the formulations were not oily or sticky and maintained the skin's suppleness over time. Formulations had a 'nude skin' touch and created a natural protective film.
The two formulations were well-tolerated and increased skin hydration in clinical subjects, an effect that could contribute to the alleviation of sensitive skin. The formulations were shown to resemble the lipid organization of the stratum corneum, as well as penetrate the skin without disrupting the lipid lamella organization.
我们开发了创新的基础配方，旨在在成分和制剂结构两方面模仿皮肤。成分包括水、蛋白质、脂质、糖和矿物质。
我们使用体外方法对制剂及其皮肤渗透特性进行了表征，并在临床试验中评估了它们对皮肤水合作用的影响。
扫描电子显微镜（SEM）成像和 X 射线衍射用于分析制剂以及制剂对角质层（SC）结构的影响。质谱成像（MSI）用于比较制剂成分与 SC 成分，并检测它们在皮肤中的分布。进行临床研究以确认对皮肤水合作用的影响，并研究潜在的不良皮肤效应（刺激和致敏）。
制剂的 SEM 和 X 射线衍射显示，脂质呈类似 SC 脂质的片状排列。MSI 表明制剂成分与皮肤成分之间存在相似性，并且具有良好的皮肤渗透能力。这些制剂不会改变 SC 脂质的层状组织，但会增加结晶脂质和一些无定形脂质的相对比例。在体内研究中，应用后 24 小时内皮肤保持高水分水平，表现为“高度水合”和“非常水合”。两种制剂均未显示出光（感）致敏性，具有极好的耐受性。感官评估表明，制剂不油腻或粘稠，随着时间的推移能保持皮肤的柔软度。制剂具有“裸妆感”的触感，能形成自然的保护性薄膜。
两种制剂均具有良好的耐受性，并能增加临床受试者的皮肤水合作用，这种作用可能有助于缓解敏感皮肤。制剂被证明类似于角质层的脂质组织，并且能够穿透皮肤而不破坏脂质层的组织。
