Efficacy of a Moisturizer for Pruritus Accompanied With Asteatosis in Dialysis Patients: An Open-Label, Randomized, Exploratory Study.
Heparinoid
asteatosis
hemodialysis
moisturizer
pruritus
water content in the stratum corneum
Journal
Kidney medicine
ISSN: 2590-0595
Titre abrégé: Kidney Med
Pays: United States
ID NLM: 101756300
Informations de publication
Date de publication:
Historique:
entrez:
1
8
2020
pubmed:
27
6
2019
medline:
27
6
2019
Statut:
epublish
Résumé
In dialysis patients, skin disorders (dryness and itching) are frequently observed and treated with a moisturizer, in the absence of clear evidence of efficacy. An open-label, randomized, before/after, parallel-group, comparative/exploratory study. 12 Japanese patients with chronic kidney failure undergoing maintenance hemodialysis who presented with dry skin and itching. Patients received a topical heparinoid moisturizer as the study drug for 2 weeks from the first day of the study treatment, followed by either a 2-week washout (group A: 6 participants) or further 2-week treatment (group B: 6 participants). The primary end point was change in water content in the stratum corneum in the hypochondrium. Secondary end points included change in visual analogue scale itching score and subjective evaluations of symptoms. To evaluate safety, adverse events were also investigated. Water content of the stratum corneum, dryness/itching improvement rating, itching visual analogue scale/duration of itching, photographic evaluation of skin symptoms, principal investigator's overall assessment of study drug, and adverse events. Mean water content of the stratum corneum in the combined groups significantly increased at week 2 (51.2 arbitrary units [AU] vs treatment start day, 31.6 AU; Only Japanese patients were included in the study, with a small sample size. Continuous application of the topical heparinoid moisturizer increased water content in the stratum corneum and lessened itching in dialysis patients. Maruho Co, Ltd. Registered at the University Hospital Medical Information Network Clinical Trials Registry with study number UMIN000017016.
Sections du résumé
BACKGROUND
BACKGROUND
In dialysis patients, skin disorders (dryness and itching) are frequently observed and treated with a moisturizer, in the absence of clear evidence of efficacy.
STUDY DESIGN
METHODS
An open-label, randomized, before/after, parallel-group, comparative/exploratory study.
SETTING & PARTICIPANTS
METHODS
12 Japanese patients with chronic kidney failure undergoing maintenance hemodialysis who presented with dry skin and itching.
INTERVENTION
METHODS
Patients received a topical heparinoid moisturizer as the study drug for 2 weeks from the first day of the study treatment, followed by either a 2-week washout (group A: 6 participants) or further 2-week treatment (group B: 6 participants).
OUTCOMES
RESULTS
The primary end point was change in water content in the stratum corneum in the hypochondrium. Secondary end points included change in visual analogue scale itching score and subjective evaluations of symptoms. To evaluate safety, adverse events were also investigated.
MEASUREMENTS
METHODS
Water content of the stratum corneum, dryness/itching improvement rating, itching visual analogue scale/duration of itching, photographic evaluation of skin symptoms, principal investigator's overall assessment of study drug, and adverse events.
RESULTS
RESULTS
Mean water content of the stratum corneum in the combined groups significantly increased at week 2 (51.2 arbitrary units [AU] vs treatment start day, 31.6 AU;
LIMITATIONS
CONCLUSIONS
Only Japanese patients were included in the study, with a small sample size.
CONCLUSIONS
CONCLUSIONS
Continuous application of the topical heparinoid moisturizer increased water content in the stratum corneum and lessened itching in dialysis patients.
FUNDING
BACKGROUND
Maruho Co, Ltd.
TRIAL REGISTRATION
BACKGROUND
Registered at the University Hospital Medical Information Network Clinical Trials Registry with study number UMIN000017016.
Identifiants
pubmed: 32734199
doi: 10.1016/j.xkme.2019.04.008
pii: S2590-0595(19)30047-0
pmc: PMC7380392
doi:
Types de publication
Journal Article
Langues
eng
Pagination
191-199Informations de copyright
© 2019 The Authors.
Références
Am J Nephrol. 2000 Nov-Dec;20(6):437-42
pubmed: 11146309
Acta Derm Venereol. 1993 Oct;73(5):335-9
pubmed: 7904396
Skin Res Technol. 2018 Aug;24(3):351-358
pubmed: 29923639
Am J Clin Dermatol. 2003;4(11):771-88
pubmed: 14572299
Br J Dermatol. 2008 Sep;159(3):567-77
pubmed: 18616783
Nephrol Dial Transplant. 2007 Nov;22(11):3268-72
pubmed: 17595180
Acta Derm Venereol. 1986;66(4):281-4
pubmed: 2430395
Clin Exp Dermatol. 1991 Nov;16(6):444-7
pubmed: 1806320
Kidney Int. 2015 Apr;87(4):685-91
pubmed: 24402092
Nephrol Dial Transplant. 2006 Dec;21(12):3495-505
pubmed: 16968725
Semin Nephrol. 2015 Jul;35(4):383-91
pubmed: 26355256
Arzneimittelforschung. 2011;61(2):85-91
pubmed: 21428242
Kidney Int. 2006 May;69(9):1626-32
pubmed: 16672924
Nephrol Dial Transplant. 2004 Nov;19(11):2709-12
pubmed: 15328388
Clin J Am Soc Nephrol. 2010 Aug;5(8):1410-9
pubmed: 20558560