We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00693654
First Posted: June 9, 2008
Last Update Posted: April 25, 2017
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.
Collaborator:
Stiefel, a GSK Company
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
  Purpose
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.

Condition Intervention Phase
Pruritis Drug: Sarna Drug: Cetaphil Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 28
Study Start Date: November 2006
Study Completion Date: October 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sarna Lotion
1% pramoxine Sarna lotion
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
Placebo Comparator: Placebo Cetaphil lotion
Placebo Cetaphil lotion
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693654


Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Stiefel, a GSK Company
Investigators
Principal Investigator: Alan Fleischer, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00693654     History of Changes
Other Study ID Numbers: 00000656
31648 ( Other Identifier: WakeForest )
First Submitted: June 5, 2008
First Posted: June 9, 2008
Results First Submitted: November 12, 2010
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Uremic Pruritis

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Emollients
Pramoxine
Dermatologic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents