Status:
COMPLETED
Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
Lead Sponsor:
Wake Forest University
Collaborating Sponsors:
Stiefel, a GSK Company
Conditions:
Pruritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 tri...
Detailed Description
This was a 4-week, randomized, double-blind, controlled study. Fourteen subjects received treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil lotion). A targe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00693654
Start Date
November 1 2006
End Date
October 1 2008
Last Update
September 10 2018
Active Locations (1)
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1
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, United States, 27157