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

• Sponsor: Wake Forest University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00693654
• Collaborator: Stiefel, a GSK Company (Industry)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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)

Study Design

• Study Type: Interventional
• 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: Nov 1, 2006
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

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 Names: Cetaphil Lotion

Outcome Measures

Primary Outcome Measures

1. Investigator Global Assessment [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 = 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

Secondary Outcome Measures

1. VAS of Pruritus [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT00693654
• Other Study ID Numbers: IRB00000656; 31648
• First Posted: Jun 9, 2008
• Last Update Posted: Sep 10, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University: Uremic Pruritis
• Additional relevant MeSH terms: Pruritus

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 11/6/06 to 11/27/06 from the Salem Kidney Center in Winston Salem, NC.
Pre-assignment Detail	Subjects were randomized so that half received Sarna lotion to be applied twice daily to all areas of pruritus, the other half applied placebo lotion twice daily to areas of pruritus.

Arm/Group Title	Pramoxine Lotion	Placebo Cetaphil Lotion
Arm/Group Description	Active Medicated Pramoxine Lotion (Sarna) applied topically twice daily to areas of pruritus	Placebo lotion (Cetaphil) applied twice daily to areas of pruritus
Period Title: Overall Study
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Active	Placebo	Total
Arm/Group Description	Active Medicated Lotion (Sarna)	Placebo lotion (Cetaphil)	Total of all reporting groups
Overall Participants	14	14	28
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 100%	14 100%	28 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.9 (13.6)	58.0 (7.54)	53.5 (7.54)
Sex: Female, Male (Count of Participants)
Female	7 50%	7 50%	14 50%
Male	7 50%	7 50%	14 50%
Region of Enrollment (participants) [Number]
United States	14 100%	14 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Investigator Global Assessment
Description	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
Time Frame	Disease severity assessed at baseline and 4 weeks, week 4 reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Placebo
Arm/Group Description	Active Medicated Pramoxine Lotion (Sarna)	Placebo lotion (Cetaphil)
Measure Participants	14	14
Mean (Standard Deviation) [units on a scale]	2.63 (0.37)	2.32 (0.36)

2. Secondary Outcome

Title	VAS of Pruritus
Description	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
Time Frame	Assessed at baseline and 4 weeks, week 4 reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Placebo
Arm/Group Description	Active Medicated Lotion (Sarna)	Placebo lotion (Cetaphil)
Measure Participants	14	14
Mean (Standard Deviation) [units on a scale]	2.73 (0.12)	2.82 (0.12)

Adverse Events

Arm/Group Title	Active		Placebo
Arm/Group Description	Active Medicated Lotion (Sarna)		Placebo lotion (Cetaphil)
All Cause Mortality
	Active		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Active		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Active		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.