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

Phase 4

Completed

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)

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Sarna Lotion	Sarna	1% pramoxine Sarna lotion
Placebo Cetaphil lotion	Cetaphil	Placebo Cetaphil lotion

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment	Disease severity assessed at baseline and 4 weeks, week 4 reported	Investigator's Global Assessment Disease Severity is based on the following scale: 0 = completely clear: except for possible residual hyper pigmentation 1. = almost clear: very significant clearance (about 90%) 2. = Marked improvement: significant improvement (about 75%) 3. = Moderate improvement: intermediate between slight and marked; representing about 50% improvements 4. = Slight improvement: some improvement (about 25%); however, significant disease remaining 5. = No change (moderate to severe disease) 6. = Worse

Secondary Outcome Measures

Name	Time	Method
VAS of Pruritus	Assessed at baseline and 4 weeks, week 4 reported	Subject's self assessment of itching based on a 100 mm visual analog scale with 0 being no itching and 10 being most severe itching