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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
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
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
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, United States
Investigator Global Assessment
Investigator's Global Assessment Disease Severity is based on the following scale: 0 = completely clear: except for possible residual hyper pigmentation 1. = almost clear: very significant clearance (about 90%) 2. = Marked improvement: significant improvement (about 75%) 3. = Moderate improvement: intermediate between slight and marked; representing about 50% improvements 4. = Slight improvement: some improvement (about 25%); however, significant disease remaining 5. = No change (moderate to severe disease) 6. = Worse
Time frame: Disease severity assessed at baseline and 4 weeks, week 4 reported
VAS of Pruritus
Subject's self assessment of itching based on a 100 mm visual analog scale with 0 being no itching and 10 being most severe itching
Time frame: Assessed at baseline and 4 weeks, week 4 reported
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.