Efficacy and safety of a ceramide-based moisturizer for xerosis and chronic kidney disease associated pruritus in maintenance hemodialysis: a randomized controlled trial

Maulik Patel; Gaurang Patel; Girish Chaudhary; Akash Dholakia

doi:10.18203/issn.2455-4529.IntJResDermatol20263739

Authors

Maulik Patel Department of Nephrology, Shankus Hospital, Mehsana, Gujarat, India https://orcid.org/0009-0008-4941-3478
Gaurang Patel Department of Cardiology, Shankus Hospital, Mehsana, Gujarat, India
Girish Chaudhary Department of Pulmonary Medicine, Shankus Hospital, Mehsana, Gujarat, India
Akash Dholakia Department of Nephrology, Shankus Hospital, Mehsana, Gujarat, India

DOI:

https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20263739

Keywords:

Ceramide, Chronic kidney disease-associated pruritus, Hemodialysis, Moisturizer, Randomized controlled trial, Xerosis

Abstract

Background: Xerosis and chronic kidney disease-associated pruritus (CKD-aP) impair sleep and quality of life in patients receiving maintenance hemodialysis. Evidence for ceramide-based moisturizers in this population is limited.

Methods: This prospective, single-center, parallel-group randomized controlled trial assigned 130 adults receiving maintenance hemodialysis to a ceramide-based moisturizer applied twice daily for 8 weeks (n=65) or standard skin-care advice alone (n=65). Co-primary outcomes were changes from baseline to week 8 in Overall Dry Skin (ODS) and pruritus Visual Analog Scale (VAS) scores. Secondary outcomes included Dermatology Life Quality Index (DLQI), sleep disturbance, adherence, satisfaction, and adverse events.

Results: All participants completed follow-up. ODS scores decreased from 3.2±0.8 to 1.4±0.6 in the ceramide group and from 3.2±0.8 to 2.4±0.7 in controls (group-by-time interaction, p<0.001). VAS scores decreased from 7.1±1.3 to 2.3±1.2 and from 7.0±1.4 to 5.1±1.5, respectively (p<0.001). DLQI scores decreased from 12.1±3.4 to 4.8±2.1 and from 11.8±3.2 to 8.9±2.9, respectively (p<0.001). Sleep disturbance and satisfaction also favored the ceramide group. No serious treatment-related adverse events occurred.

Conclusions: A ceramide-based moisturizer improved xerosis, CKD-aP, dermatology-related quality of life, and sleep disturbance compared with standard skin-care advice alone. Active-comparator trials are needed to determine whether the benefit is specific to ceramides or reflects moisturization generally.

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