UA-145931898-1

A controlled comparative study of the efficacy of 1% pramoxine hydrochloride lotion for the treatment of uremic pruritus

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Pruritus is a common and disabling symptom in hemodialysis patients. Pramoxine is an FDA-approved OTC topical anesthetic that is indicated for the treatment of pain and itch associated with insect bites, dry skin, rashes, cuts, and scrapes.

Pruritus is a common and disabling symptom in hemodialysis patients. Pramoxine is an FDA-approved OTC topical anesthetic that is indicated for the treatment of pain and itch associated with insect bites, dry skin, rashes, cuts, and scrapes. This double-blind, controlled comparative study was performed to evaluate the efficacy of 1% pramoxine hydrochloride lotion in the treatment of moderate to severe uremic pruritus in adult hemodialysis patients. In this 4-week study, subjects applied either 1% pramoxine hydrochloride lotion or a placebo moisturizing lotion twice daily to all affected areas of the body.

Study visits occurred at baseline, end of week 1, and end of week 4. At baseline, subjects completed a questionnaire about pruritus location, severity, characteristics, and effects on quality of life. Subjects estimated their pruritus intensity every day by marking a visual analog scale. A moisture meter was used to assess skin moisture levels at a target lesion at baseline and end of treatment. The investigator evaluated erythema, xerosis, and lichenification at all visits and assessed the global response to treatment at weeks 1 and 4. Stinging and burning was also evaluated at weeks 1 and 4. Approximately 30 subjects were entered into the study. Comparative results from the study are presented.

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