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

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.