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

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



improvement from baseline to EOS. Figure 3B further details the percentage of subjects with each parameter at baseline with 1-point up to 4-point improvement, no change, or scored worse at EOS.

Subject Scored Quality of Life
All three parameters of QoL scoring significantly (P<0.001) improved from baseline to EOS (Figure 4). At least one parameter of QoL improved in 400 (75.8%) subjects from baseline to EOS. Figure 5 shows the percentage of all subjects who had at least 1-point improvement in each of the 3 QoL parameters.

Subject Scored Satisfaction With Treatment Outcomes and Product Features
All 6 parameters of subject satisfaction scored highly (>80%) at week 4. On day 28, 99.6% (526) of subjects were satisfied with skincare outcomes (Figure 6). At EOS, 91.5% (483) of subjects said they would continue to use the CER-containing cleanser and moisturizer to improve their DM-related xerosis.

Three typical cases illustrate the results (Figures 7-9).

DISCUSSION

The CER-containing cleanser and moisturizer were associated with significant (P<.0001) improvement in DM-related xerosis severity in 98% (519/528) of patients.

DM-related skin changes are a common complication seen in DM1 and DM2.9 DM-related dermatologic conditions vary in severity and can, for example with those who have foot ulcers, lead to significant complications including amputations.12,13

In patients with DM, functional properties of the stratum corneum (SC) may be altered, impacting skin barrier function and leading to xerosis, pruritus, hyperkeratosis, and inflammation.13 The status of the permeability and antimicrobial barrier of the skin in DM remains unknown.12 In vivo impairment of the skin barrier (independent of the etiology) results from impairment of skin barrier homeostasis and decreases in epidermal proliferation and lipid synthesis.14 In vivo and in vitro pre-clinical studies show that DM alters epidermis histology and suppresses the proliferation of keratinocytes.15 Impaired keratinocyte homeostasis and epidermal barrier function are risk factors