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Winston Salem, North Carolina 27157


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.


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.


NCT ID:

NCT00693654


Primary Contact:

Principal Investigator
Alan Fleischer, MD
Wake Forest University


Backup Contact:

N/A


Location Contact:

Winston Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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