An International Evaluation of a Ceramide-Containing Hydrating Cleanser and Moisturizing Cream for the Improvement of Diabetes Mellitus-Related Xerosis

January 2023 | Volume 22 | Issue 1 | 65 | Copyright © January 2023


Published online December 31, 2022

doi:10.36849/JDD.7168 Citation: Kirsner R, Andriessen A. An international evaluation of a ceramide-containing hydrating cleanser and moisturizing cream for the improvement of diabetes mellitus-related xerosis. J Drugs Dermatol. 2023;22(1):65-73. doi: 10.36849/JDD.7168. 

Robert S. Kirsner MD PhDa, Anneke Andriessen PhDb

aDr. Phillip Frost Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL
bRadboud UMC Nijmegen, Andriessen Consultants, Malden, The Netherlands

Abstract
Background: Diabetes mellitus (DM) is a common disease. Seventy percent of patients present with a cutaneous complication, including xerosis. Ceramides-containing (CER) skincare promotes a healthy skin barrier. This international, multicenter, open-label cohort study evaluated twice-daily application for 1 month of CER-containing cleanser and moisturizing cream to improve DM-related xerosis.
Methods: Patients between 18 and 75 years with DM-related xerosis at baseline were eligible. Study visits were on days -30 to 0 (screening), day 0 (baseline), and week 4 (end of study). Evaluations included the Global Aesthetic Improvement Scale (GAIS) and the physician and subject-scored Dry Skin Classification Scale (DSCS). Subject-scored measures of quality of life (QoL) and satisfaction scale with treatment outcomes and product features took place at the end of the study. Tolerance was assessed by monitoring adverse events (AEs).
Results: N = 528 subjects from 19 countries completed treatment, the majority having DM type 2 (82.6%). N = 519 (98.3%) met the primary endpoint criteria (GAIS). The CER-containing skincare regimen resulted in statistically significant improvements from baseline (P<0.001) in all parameters of the physician and subject DSCS scores. Patients reported QoL significantly improved by week 4 (P<0.001). At the end of the study, 99.6% (525) of subjects were satisfied with skincare outcomes and product features (99.4% [524]). No product-related AEs were reported during the study.
Conclusion: CER-containing cleanser and moisturizer were associated with statistically significant improvements in DM-associated xerosis, physician and subject scored severity, patient satisfaction, and improved QoL. The skincare regimen was well tolerated.

J Drugs Dermatol. 2023;22(1):65-73. doi:10.36849/JDD.7168

Citation: Kirsner R, Andriessen A. An international evaluation of a ceramide-containing hydrating cleanser and moisturizing cream for the improvement of diabetes mellitus-related xerosis. J Drugs Dermatol. 2023;22(1):65-73. doi: 10.36849/JDD.7168. 

INTRODUCTION

Diabetes mellitus (DM) is a common and debilitating disease that affects the skin.1-4 DM is a worldwide public health problem projected to affect 592 million people (10.1% of the world's population) by 2035.1 Type 2 diabetes mellitus (DM2) comprises most cases of DM and is primarily the result of excess body weight and physical inactivity.2 Between 30% and 70% of patients with DM will present with a DM-related cutaneous complication.1-4 Despite the growing interest in DM-related dermatologic conditions, data are limited and mainly address diabetic foot syndrome and ulcers.3 Dermatologic conditions linked with DM vary in severity and can be benign, deforming, or life-threatening.1-4 Such skin conditions offer insight into patients' glycemic control and can be the first sign of DM in undiagnosed patients.3,4 Cutaneous disorders associated with DM can cause pain and severely impact quality of life (QoL), including interpersonal relationships.3 Recognition and management of these conditions are important in maximizing QoL and avoiding severe adverse effects (AEs).3

DM-related xerosis can be associated with pruritus, more often localized, although the pathogenesis is not fully understood.3,4 However, in DM the underlying pathophysiology, course of disease, comorbidities, complications, and treatment predispose patients to pruritus.3,4 A prospective cross-sectional study of 120 patients with DM demonstrated that skin xerosis was significantly more advanced in patients with pruritus than those without pruritus (P<0.01).4 Pruritus is more likely in DM patients with xerosis or diabetic neuropathy.3,4 Ceramides (CERs) are essential physiologic lipids required to construct and maintain the epidermal barrier. CERs-containing skincare using cleansers and moisturizers has been beneficial for xerosis related to various skin conditions.5-7 This study aimed to investigate the benefits of a CER-containing skincare regimen on clinical signs and QoL in patients with DM-related xerosis.

MATERIALS AND METHODS

Study Treatment
All included subjects received unblinded, currently marketed study products (CeraVe® Hydrating Cleanser and Moisturizing Cream, CeraVe US). Subjects were instructed to apply the cleanser and moisturizer twice a day to the areas of xerosis.
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