Back to resultsComparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
Primary Purpose
Pruritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sarna
Cetaphil
Sponsored by
About this trial
This is an interventional treatment trial for Pruritis focused on measuring Uremic Pruritis
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.
Sites / Locations
- Wake Forest University Health Sciences Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sarna Lotion
Placebo Cetaphil lotion
Arm Description
1% pramoxine Sarna lotion
Placebo Cetaphil lotion
Outcomes
Primary Outcome Measures
Investigator Global Assessment
Investigator's Global Assessment Disease Severity is based on the following scale:
0 = completely clear: except for possible residual hyper pigmentation
= almost clear: very significant clearance (about 90%)
= Marked improvement: significant improvement (about 75%)
= Moderate improvement: intermediate between slight and marked; representing about 50% improvements
= Slight improvement: some improvement (about 25%); however, significant disease remaining
= No change (moderate to severe disease)
= Worse
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00693654
First Posted
June 5, 2008
Last Updated
August 9, 2018
Sponsor
Wake Forest University
Collaborators
Stiefel, a GSK Company
1. Study Identification
Unique Protocol Identification Number
NCT00693654
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
Collaborators
Stiefel, a GSK Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritis
Keywords
Uremic Pruritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sarna Lotion
Arm Type
Experimental
Arm Description
1% pramoxine Sarna lotion
Arm Title
Placebo Cetaphil lotion
Arm Type
Placebo Comparator
Arm Description
Placebo Cetaphil lotion
Intervention Type
Drug
Intervention Name(s)
Sarna
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cetaphil
Other Intervention Name(s)
Cetaphil Lotion
Intervention Description
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
Primary Outcome Measure Information:
Title
Investigator Global Assessment
Description
Investigator's Global Assessment Disease Severity is based on the following scale:
0 = completely clear: except for possible residual hyper pigmentation
= almost clear: very significant clearance (about 90%)
= Marked improvement: significant improvement (about 75%)
= Moderate improvement: intermediate between slight and marked; representing about 50% improvements
= Slight improvement: some improvement (about 25%); however, significant disease remaining
= No change (moderate to severe disease)
= Worse
Time Frame
Disease severity assessed at baseline and 4 weeks, week 4 reported
Secondary Outcome Measure Information:
Title
VAS of Pruritus
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Fleischer, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33283264
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.
Results Reference
derived
Learn more about this trial
Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
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