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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Wake Forest School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00693654
First received: June 5, 2008
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Pruritis
Drug: Sarna
Drug: Cetaphil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • The primary outcome is investigator assessment of pruritus score and response to treatment using an itch questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome is the effect of treatment on skin moisturization and quality of life at baseline and end of treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2006
Estimated Study Completion Date: October 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
active medicated lotion (Sarna)
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
Other Name: Sarna
Placebo Comparator: 2
Placebo lotion (Cetaphil)
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 Name: Cetaphil Lotion

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00693654

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Alan Fleischer, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Alan Fleischer, MD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00693654     History of Changes
Other Study ID Numbers: 00000656, 31648
Study First Received: June 5, 2008
Last Updated: June 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Uremic Pruritis

Additional relevant MeSH terms:
Pramoxine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014