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

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ClinicalTrials.gov Identifier: NCT00693654
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : April 25, 2017
Last Update Posted : September 10, 2018
Stiefel, a GSK Company
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease Intervention/treatment Phase
Pruritis Drug: Sarna Drug: Cetaphil Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : November 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Itching

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

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

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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
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Principal Investigator: Alan Fleischer, MD Wake Forest University Health Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00693654    
Other Study ID Numbers: IRB00000656
31648 ( Other Identifier: WakeForest )
First Posted: June 9, 2008    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: September 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Uremic Pruritis
Additional relevant MeSH terms:
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Skin Diseases
Skin Manifestations