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Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
This study is ongoing, but not recruiting participants.
Sponsored by: Wake Forest University
Information provided by: Wake Forest University
ClinicalTrials.gov Identifier: NCT00693654
  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 IV

MedlinePlus related topics: Dialysis Itching Kidney Failure
Drug Information available for: Pramocaine Pramoxine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title: A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients

Further study details as provided by Wake Forest University:

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
1: Experimental
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
2: Placebo Comparator
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

  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
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 University
Investigators
Principal Investigator: Alan Fleischer, MD Wake Forest University
  More Information

No publications provided

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

Keywords provided by Wake Forest University:
Uremic Pruritis

Study placed in the following topic categories:
Tocopherols
Pruritus
Tocopherol acetate
Vitamin E
Glycerol
Citric Acid
Petrolatum
Ethanol
Alpha-Tocopherol

ClinicalTrials.gov processed this record on February 12, 2009