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

Completed · Phase 4 · Has a placebo group

Conditions studied: Pruritis

In brief

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.

Key facts

Study ID

NCT00693654

Run by

Wake Forest University

People needed

28

Starts

2006-11-01

Expected to finish

2008-10-01

Last updated by the study team

2018-09-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wake Forest University Health Sciences Dermatology — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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