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
- 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
- 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.
- 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.