Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
Condition: Pruritis
MeSH terms: Pruritus
Intervention: Sarna; Cetaphil
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Uremic Pruritis

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.
    

Eligibility 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.