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

NCT00693654 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB0000065631648
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritis

Keywords

Uremic Pruritis

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment

  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

  Disease severity assessed at baseline and 4 weeks, week 4 reported

Secondary Outcomes (1)

• VAS of Pruritus

  Assessed at baseline and 4 weeks, week 4 reported

Study Arms (2)

Sarna Lotion

EXPERIMENTAL

1% pramoxine Sarna lotion

Drug: Sarna

Placebo Cetaphil lotion

PLACEBO COMPARATOR

Placebo Cetaphil lotion

Drug: Cetaphil

Interventions

Sarna DRUG

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

Sarna Lotion

Cetaphil DRUG

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

Also known as: Cetaphil Lotion

Placebo Cetaphil lotion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead
• Stiefel, a GSK Company: collaborator

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

  PMID: 33283264 DERIVED

MeSH Terms

Conditions

Pruritus

Interventions

mRNA Vaccines; cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors

Results Point of Contact

• Title: Alan Fleischer, Jr., MD
• Organization: Wake Forest University Health Sciences

afleisch@wfubmc.edu

336-716-7753

Study Officials

• Alan Fleischer, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: November 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: October 1, 2008
• Last Updated: September 10, 2018
• Results First Posted: April 25, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)