Pruritis
Conditions
Keywords
Uremic Pruritis
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)
Interventions
DRUGSarna
Active Ingredient: Pramoxine Hydrochloride Inactive ingredients:Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate (&) PEG-100 Stearate, Isopropyl Myristate, Petrolatum, PEG 8 Stearate, Purified Water, Stearic Acid, Sodium Hydroxide
DRUGCetaphil
Purified Water, Glycerin, Hydrogenated Polyisobutene, Cetearyl Alcohol, Ceteareth 20, Macadamia Nut Oil, Dimethicone, Tocopheryl Acetate, Stearoxytrimethylsilane, Stearyl Alcohol, Panthenol, Farnesol, Benzyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Citric Acid
Sponsors
Stiefel, a GSK Company
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 11/6/06 to 11/27/06 from the Salem Kidney Center in Winston Salem, NC.
Pre-assignment details
Subjects were randomized so that half received Sarna lotion to be applied twice daily to all areas of pruritus, the other half applied placebo lotion twice daily to areas of pruritus.
Participants by arm
| Arm | Count |
|---|---|
| Active Active Medicated Lotion (Sarna) | 14 |
| Placebo Placebo lotion (Cetaphil) | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Placebo | Active | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Continuous | 58.0 years STANDARD_DEVIATION 7.54 | 48.9 years STANDARD_DEVIATION 13.6 | 53.5 years STANDARD_DEVIATION 7.54 |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Investigator Global Assessment
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
Time frame: Disease severity assessed at baseline and 4 weeks, week 4 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Investigator Global Assessment | 2.63 units on a scale | Standard Deviation 0.37 |
| Placebo | Investigator Global Assessment | 2.32 units on a scale | Standard Deviation 0.36 |
Secondary
VAS of Pruritus
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
Time frame: Assessed at baseline and 4 weeks, week 4 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | VAS of Pruritus | 2.73 units on a scale | Standard Deviation 0.12 |
| Placebo | VAS of Pruritus | 2.82 units on a scale | Standard Deviation 0.12 |