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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00693654
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : April 25, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Stiefel, a GSK Company
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE June 5, 2008
First Posted Date  ICMJE June 9, 2008
Results First Submitted Date  ICMJE November 12, 2010
Results First Posted Date  ICMJE April 25, 2017
Last Update Posted Date September 10, 2018
Study Start Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
Investigator Global Assessment [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
The primary outcome is investigator assessment of pruritus score and response to treatment using an itch questionnaire [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
VAS of Pruritus [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
The secondary outcome is the effect of treatment on skin moisturization and quality of life at baseline and end of treatment. [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
Official Title  ICMJE A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pruritis
Intervention  ICMJE
  • Drug: Sarna
    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
  • Drug: Cetaphil
    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
    Other Name: Cetaphil Lotion
Study Arms  ICMJE
  • Experimental: Sarna Lotion
    1% pramoxine Sarna lotion
    Intervention: Drug: Sarna
  • Placebo Comparator: Placebo Cetaphil lotion
    Placebo Cetaphil lotion
    Intervention: Drug: Cetaphil
Publications * Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12:CD011393. doi: 10.1002/14651858.CD011393.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2008)
30
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693654
Other Study ID Numbers  ICMJE IRB00000656
31648 ( Other Identifier: WakeForest )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Original Responsible Party Alan Fleischer, MD, Wake Forest University Health Sciences
Current Study Sponsor  ICMJE Wake Forest University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Stiefel, a GSK Company
Investigators  ICMJE
Principal Investigator: Alan Fleischer, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP