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

Condition(s) targeted: Pruritis

Intervention: Sarna (Drug); Cetaphil (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Alan Fleischer, MD, Principal Investigator, Affiliation: Wake Forest School of Medicine

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.

Official title: A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The primary outcome is investigator assessment of pruritus score and response to treatment using an itch questionnaire

Secondary outcome: The secondary outcome is the effect of treatment on skin moisturization and quality of life at baseline and end of treatment.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

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

Starting date: November 2006
Last updated: June 11, 2008