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Trial record 30 of 32 for:    PANTHENOL

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
Sponsor:
Collaborator:
Stiefel, a GSK Company
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pruritis
Interventions Drug: Sarna
Drug: Cetaphil
Enrollment 28
Recruitment Details Subjects were recruited from 11/6/06 to 11/27/06 from the Salem Kidney Center in Winston Salem, NC.
Pre-assignment Details 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
Hide 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
Arm/Group Title Active Placebo Total
Hide Arm/Group Description Active Medicated Lotion (Sarna) Placebo lotion (Cetaphil) Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
48.9  (13.6) 58.0  (7.54) 53.5  (7.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
7
  50.0%
7
  50.0%
14
  50.0%
Male
7
  50.0%
7
  50.0%
14
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 28 participants
14 14 28
1.Primary Outcome
Title Investigator Global Assessment
Hide Description

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
Time Frame Disease severity assessed at baseline and 4 weeks, week 4 reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Placebo
Hide Arm/Group Description:
Active Medicated Pramoxine Lotion (Sarna)
Placebo lotion (Cetaphil)
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.63  (0.37) 2.32  (0.36)
2.Secondary Outcome
Title VAS of Pruritus
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Placebo
Hide Arm/Group Description:
Active Medicated Lotion (Sarna)
Placebo lotion (Cetaphil)
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.73  (0.12) 2.82  (0.12)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Placebo
Hide Arm/Group Description Active Medicated Lotion (Sarna) Placebo lotion (Cetaphil)
All-Cause Mortality
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alan Fleischer, Jr., MD
Organization: Wake Forest University Health Sciences
Phone: 336-716-7753
EMail: afleisch@wfubmc.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00693654     History of Changes
Other Study ID Numbers: IRB00000656
31648 ( Other Identifier: WakeForest )
First Submitted: June 5, 2008
First Posted: June 9, 2008
Results First Submitted: November 12, 2010
Results First Posted: April 25, 2017
Last Update Posted: September 10, 2018