Clinical trial NCT00693654: Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
Official title: A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pruritis
Keywords: Uremic Pruritis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Stiefel, a GSK Company
First posted: 2008-06-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 trial.

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 target lesion limited to one anatomic site, excluding face and genitals, was selected at baseline. Each subject was instructed to apply lotion twice daily to all affected areas of pruritus for four weeks. The use of any other topical or systemic medication to treat uremic pruritus was not permitted while participating in the study. Subjects were clinically evaluated for erythema, xerosis, lichenification and overall severity at baseline, week 1, and week 4 (end of study)

Eligibility 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.

Primary outcomes:
measure: Investigator Global Assessment
timeFrame: Disease severity assessed at baseline and 4 weeks, week 4 reported
Secondary outcomes:
measure: VAS of Pruritus
timeFrame: Assessed at baseline and 4 weeks, week 4 reported
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Alan Fleischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.