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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University
• Collaborator: Stiefel, a GSK Company
• Treatments: Pramoxine

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.