This trial is active, not recruiting.

Condition pruritis
Treatments sarna, cetaphil
Phase phase 4
Sponsor Wake Forest School of Medicine
Start date November 2006
End date November 2006
Trial size 30 participants
Trial identifier NCT00693654, 00000656, 31648


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
active medicated lotion (Sarna)
sarna 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 lotion (Cetaphil)
cetaphil Cetaphil Lotion
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 Outcomes

The primary outcome is investigator assessment of pruritus score and response to treatment using an itch questionnaire
time frame: 4 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients
Principal investigator Alan Fleischer, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.