Skin acceptability of a cosmetic moisturizer formulation in female subjects with sensitive skin

Abstract

PurposeThis 3-week, open-label, noncomparative clinical study evaluated the skin acceptability of a cosmetic moisturizer in subjects with sensitive skin, by monitoring adverse events (AEs) and cutaneous discomfort related to normal usage.Materials and methodsFemale subjects aged between 18–60 years, with Fitzpatrick phototype classification I–IV and sensitive skin, verified by a positive reaction on the stinging test at screening, were included. Subjects applied the moisturizer to their face and body twice daily for 21±2 days at home and recorded study product usage and feelings of cutaneous discomfort (eg, dryness, prickling, stinging, and itching) in a diary; any AEs were reported to the clinic. At study end, skin acceptability of the moisturizer was investigator-assessed based on the nature of AEs and subjects’ self-reported feelings of discomfort, and by clinical evaluation of skin reactions in the area of moisturizer application (appearance of erythema, formation of edema, and skin desquamation; scored according to an adapted Draize and Kligman scale). Only subjects with a treatment compliance of ≥80% were included in the final analysis.ResultsIn total, 35 subjects initiated and completed the study; all were compliant to the minimum study product usage. Per investigator clinical dermatological assessment at study end, none of the 35 subjects had skin reactions in the area of moisturizer application and there were no reported AEs. One subject reported sensations of mild prickling and itching immediately after applying the moisturizer (not classified as AEs), which spontaneously remitted after complete absorption of the product and were noted only in exposed areas. These events were considered by the investigator as being possibly/probably related to the use of study product; however, no clinical signs of skin reaction were observed in the exposed areas.ConclusionThis cosmetic moisturizer appears generally well tolerated and suitable for topical use in subjects with sensitive skin.

Revitalizing the skin: Exploring the role of barrier repair moisturizers

“…In this regard, moisturizers containing functional ingredients such as endocannabinoids and based on the principles of biomimic technology are gaining increasing importance 21–25 . The endocannabinoid system (ECS) balances and regulates the proliferation, differentiation, and survival of skin cells and is thus believed to play an active role in protective mechanisms in skin barrier function 26 .…”

Photoprotective effects of sphingomyelin-containing milk phospholipids in ultraviolet B–irradiated hairless mice by suppressing nuclear factor-κB expression

“…Skin hydration is closely related to the moisture content of the stratum corneum, which is the outermost layer of the epidermis. The stratum corneum has an organic complex structure of proteins and lipids that forms the skin barrier; a decrease in the moisture content of the stratum corneum results in dryness of the skin and abnormalities in skin barrier function (Nisbet, 2018). Furthermore, the main role of ceramide in the stratum corneum is protecting the epidermal barrier, and a decrease in the ceramide content in the stratum corneum weakens the skin barrier function and acts as a cause of increased water loss between the skin.…”

Lactobacillus reuteri DSM 17938 as a Novel Topical Cosmetic Ingredient: A Proof of Concept Clinical Study in Adults with Atopic Dermatitis

“…These two products in this study used on subjects with AD were both concluded to be cutaneously acceptable by the dermatologist investigator Table A1 ( Appendix A ). Although some reactions were noted, it can be concluded that these are quite normal when using such products on subjects with such a condition, and can occur in some individuals with sensitive skin when applying new products [ 50 ]. We can observe from these results that L. reuteri DSM 17938 as an additive ingredient to the topical ointment does not affect the cosmetic or cutaneous acceptability of the product.…”