NCT00693654

Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients

A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled comparative trial.

Detailed description

This was a 4-week, randomized, double-blind, controlled study. Fourteen subjects received treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil lotion). A target lesion limited to one anatomic site, excluding face and genitals, was selected at baseline. Each subject was instructed to apply lotion twice daily to all affected areas of pruritus for four weeks. The use of any other topical or systemic medication to treat uremic pruritus was not permitted while participating in the study. Subjects were clinically evaluated for erythema, xerosis, lichenification and overall severity at baseline, week 1, and week 4 (end of study)

Conditions

• Pruritis

Interventions

Type	Name	Description
DRUG	Sarna	Active Ingredient: Pramoxine Hydrochloride Inactive ingredients:Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate (\&) PEG-100 Stearate, Isopropyl Myristate, Petrolatum, PEG 8 Stearate, Purified Water, Stearic Acid, Sodium Hydroxide
DRUG	Cetaphil	Purified Water, Glycerin, Hydrogenated Polyisobutene, Cetearyl Alcohol, Ceteareth 20, Macadamia Nut Oil, Dimethicone, Tocopheryl Acetate, Stearoxytrimethylsilane, Stearyl Alcohol, Panthenol, Farnesol, Benzyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Citric Acid

Timeline

• Start date: 2006-11-01
• Primary completion: 2006-11-01
• Completion: 2008-10-01
• First posted: 2008-06-09
• Last updated: 2018-09-10
• Results posted: 2017-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study