Journal of Clinical and Aesthetic Dermatology

MAY 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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30 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY May 2018 • Volume 11 • Number 5 O R I G I N A L R E S E A R C H A Adequate moisturization and barrier repair are critically important for a number of dermatologic conditions. Various types of dermatoses and so-called "sensitive skin" are thought to be related to a dysfunctional skin barrier. This could be due to a number of conditions, such as atopic dermatitis, senile itch, eczema, allergic contact dermatitis, and cosmetic intolerance syndrome. A well-formulated cream for sensitive skin can enhance barrier repair, increase the water-holding capacity of the skin, and optimize healing. Approximately 50 percent of intercellular lipids are ceramides, with cholesterol and free fatty acids representing the other constituents. In some individuals with sensitive skin, ceramides 1 and 3 are thought be deficient. 1 It then follows that one approach to improving dermatitis and sensitive skin is the application of ceramides. Synthetic ceramides mimic natural ceramides but are contaminant-free and stable in formulation. The synthetic ceramide combination PC-104 could augment the natural barrier function. 2 However, the function of ceramides can be augmented with anti-inflammatory and antibacterial derivatives, such as glycerrhetinic acid, an extract of the licorice root, and proanthocyanidins, an extract of grape seeds. 3 It is thought that the anti-inflammatory activity of these ingredients could be due to inhibited proliferative activity of T-cells via mitogen- activated protein kinase and nuclear factor kappa B signaling pathways. Other additives such as palmitoylethanolamide (PEA), a fatty acid amide, can bind to nuclear receptors, reducing the itch sensation. 4 Thus, a cream composed of these ingredients addresses many of the physiologic issues associated with sensitive skin. The objective of this study was to determine if a therapeutic cream containing PC-104 synthetic ceramides, glycerrhetinic acid, proanthocyanidins, and palmitoylethanolamide MEA could assist in the amelioration of the signs and symptoms of mild-to-moderate atopic dermatitis and other types of pruritic dermatoses (e.g., senile itch, cosmetic intolerance syndrome) in children and adults. METHODS In this single-site, monadic study, investigators enrolled 50 healthy subjects (12 male and 38 female, 23 African-American and 27 Caucasian) who were 1 to 86 years of age (median: 38.0 years, interquartile range: 38.5 years) with mild-to-moderate atopic dermatitis or other xerotic or pruritic dermatoses. All subjects provided signed informed consent (Concordia Clinical Research, Beach Haven, New Jersey, USA). Subjects continued using their own self-selected cleansers, but were not allowed to apply any moisturizers on the affected areas except for the study product. Qualified subjects underwent baseline investigator assessment and subject self-assessment and received the study cream (NeoCera™; Exeltis USA, Florham A B S T R A C T Objective: The goal of this study was to determine if a therapeutic cream containing PC- 104 synthetic ceramides and other ingredients could help to ameliorate signs and symptoms of mild-to-moderate atopic dermatitis and other xerotic or pruritic dermatoses. Design: In this single-site, four-week study, subjects (n=50) were instructed to apply the study product three times daily to all affected areas, including a target site for evaluation and photography at baseline, Week 2, and Week 4 visits. Setting: This study took place in the private practice of the senior author. Participants: Eligible subjects with mild-to-moderate sensitive skin were included. Measurements: Evaluations included Investigator Global Assessment (IGA) scale score; subject satisfaction assessments; and noninvasive assessments of transepidermal water loss, increases in water content of the skin, and improvements in skin smoothness. Results: Use of the ceramide cream resulted in a 100-percent improvement in IGA scores and a 67-percent improvement in overall subject skin assessment scores after four weeks of use in individuals with sensitive skin conditions. Improvements were statistically significant. Statistically significant improvements were also observed in transepidermal water loss, water content of the skin, and skin smoothness. Adverse events were not observed. Conclusion: These data demonstrate that a proprietary combination of ceramide PC-104, palmitamide MEA, glycerrhetinic acid, and grape seed extract in a glycerin, dimethicone, and petrolatum vehicle was effective in reducing the signs and symptoms of mild-to- moderate atopic dermatitis and other types of pruritic dermatoses (e.g., senile itch, cosmetic intolerance syndrome) in children and adults. KEYWORDS: Ceramides, atopic dermatitis, sensitive skin, pediatric, adult The Efficacy of a Ceramide- based Cream in Mild-to- moderate Atopic Dermatitis by ZOE DIANA DRAELOS, MD, and ISABELLE RAYMOND, PhD Dr. Draelos is with Dermatology Consulting Services in High Point, North Carolina. Dr. Raymond is with Exeltis USA in Florham Park, New Jersey. J Clin Aesthet Dermatol. 2018;11(5):30–32 FUNDING: This study was supported by a grant from Exeltis USA. DISCLOSURES: Dr. Draelos has no conflicts of interest relevant to the content of this article. Dr. Raymond is an employee of Exeltis USA. CORRESPONDENCE: Zoe Diana Draelos, MD; Email: zdraelos@northstate.net

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