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

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.

Study Overview

• Status: Completed
• Conditions: Pruritis
• Intervention / Treatment: Drug: Sarna; Drug: Cetaphil

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)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients 18 years of age to 70 years of age.
• A diagnosis of moderate to severe pruritus.
• At least 3 episodes of itch over a period of 2 weeks, each lasting for 2 minutes or more.
• Symptoms of itch in regular pattern over 6 months.
• Itch Visual analog scale (VAS) of 3cm or more out of 10 cm.
• All subjects will be end stage renal failure patients undergoing hemodialysis for at least 3 months, who have substantial pruritus for more than 6 months. Substantial pruritus is defined as persistent pruritus impairing sleep or daytime activity.
• Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
• The ability to understand and sign a written informed consent form, which must be obtained prior to treatment.

Exclusion Criteria:

• Presence of infection (as defined by the investigator) on the area to be treated.
• Subjects with history of pruritus predating renal failure and subjects with skin disease unrelated to uremia, such as atopic dermatitis, will be excluded.
• Use of systemic medications for treatment of pruritus including corticosteroids within the past 4 weeks and during the study.
• Use of topical medications for treatment of pruritus, including corticosteroids, within the past week.
• Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sarna Lotion; 1% pramoxine Sarna lotion	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
Placebo Comparator: Placebo Cetaphil lotion	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; Other Names: Cetaphil Lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment	Investigator's Global Assessment Disease Severity is based on the following scale: 0 = completely clear: except for possible residual hyper pigmentation; = almost clear: very significant clearance (about 90%); = Marked improvement: significant improvement (about 75%); = Moderate improvement: intermediate between slight and marked; representing about 50% improvements; = Slight improvement: some improvement (about 25%); however, significant disease remaining; = No change (moderate to severe disease); = Worse	Disease severity assessed at baseline and 4 weeks, week 4 reported

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed at baseline and 4 weeks, week 4 reported

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: Stiefel, a GSK Company
• Investigators: Principal Investigator: Alan Fleischer, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: June 5, 2008
• First Submitted That Met QC Criteria: June 6, 2008
• First Posted (Estimate): June 9, 2008

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Uremic Pruritis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: IRB00000656; 31648 (WakeForest)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No