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

Pruritis Clinical Trial

Official title:

A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693654
• Other study ID #: IRB00000656
• Secondary ID: 31648
• Status: Completed
• Phase: Phase 4
• Start date: November 2006
• Est. completion date: October 2008

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2008
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pruritis
• Pruritus

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Dermatology	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	Stiefel, a GSK Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease severity assessed at baseline and 4 weeks, week 4 reported
Secondary	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	Assessed at baseline and 4 weeks, week 4 reported