Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
This trial is active, not recruiting.
|Sponsor||Wake Forest School of Medicine|
|Start date||November 2006|
|End date||November 2006|
|Trial size||30 participants|
|Trial identifier||NCT00693654, 00000656, 31648|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
The primary outcome is investigator assessment of pruritus score and response to treatment using an itch questionnaire
time frame: 4 weeks
The secondary outcome is the effect of treatment on skin moisturization and quality of life at baseline and end of treatment.
time frame: 4 weeks
Male or female participants from 18 years up to 70 years old.
- 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.
- 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.
|Official title||A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients|
|Principal investigator||Alan Fleischer, MD|
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