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Trial record 20 of 49 for:    Sodium Lauryl Sulfate

Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

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ClinicalTrials.gov Identifier: NCT02224625
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : May 30, 2016
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Medline Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Surgery
Interventions Drug: 2% CHG Cloth solution
Device: Vehicle Cloth
Drug: Active Comparator
Other: Saline
Other: SLS
Enrollment 249
Recruitment Details 39 of the 249 participants participated in both the Irritation and Sensitization Studies.
Pre-assignment Details Participants received up to 5 products simultaneously on their skin. SLS was only used in the Irritation study (39 subjects) as a positive control.
Arm/Group Title 2% CHG Cloth, Vehicle, DynaHex, Saline, SLS
Hide Arm/Group Description Chlorhexidine Gluconate 2% cloth solution Vehicle solution of 2% CHG cloth DynaHex (2% CHG) 0.9% Saline Sodium Lauryl Sulfate
Period Title: Irritation
Started 39
Completed 33
Not Completed 6
Reason Not Completed
Adverse Event             6
Period Title: Sensitization
Started 249 [1]
Completed 194
Not Completed 55
Reason Not Completed
Adverse Event             55
[1]
Subjects from Irritation study also participated in Sensitization Study
Arm/Group Title 2% CHG, Vehicle, DynaHex, Saline
Hide Arm/Group Description Chlorhexidine Gluconate 2% Cloth Solution Vehicle solution of CHG cloth DynaHex 2% CHG solution 0.9% Saline Sodium Lauryl Sulfate (only used in Irritation Study)
Overall Number of Baseline Participants 249
Hide Baseline Analysis Population Description
Participants in the Sensitization study received the following 4 products ( 2% CHG cloth, Vehicle cloth, DynaHex and Saline). Participants in the Irritation study received the same 4 products in addition to SLS.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants
<=18 years
8
   3.2%
Between 18 and 65 years
226
  90.8%
>=65 years
15
   6.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 249 participants
38
(16 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants
Female
147
  59.0%
Male
102
  41.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 249 participants
249
1.Primary Outcome
Title Grading Scale for Visual Evaluation of Skin Condition
Hide Description

Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.

Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.

Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading

Time Frame 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received more than one product at a time.
Arm/Group Title 2% CHG Cloth Vehicle Cloth DynaHex (2% CHG) Saline Sodium Lauryl Sulfate (SLS)
Hide Arm/Group Description:

Chlorhexidine Gluconate 2%

2% CHG Cloth: CHG solution on cloth

Excipients on cloth

Vehicle Cloth: Excipients from CHG cloth only

Chlorhexidine Gluconate 2% solution

Active Comparator: 2% CHG solution

0.9% sodium chloride

Saline: Negative control

Sodium lauryl sulfate to produce mild irritation as a positive control

SLS: Provides a slight irritation for a positive control

Overall Number of Participants Analyzed 249 249 249 249 39
Mean (Full Range)
Unit of Measure: Scores Ranging (0-7)
Irritation Mean Visualization Score Baseline
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Irritation Mean Visualization Score Day 21
2.9
(0 to 4)
1.4
(0 to 4)
3.3
(3 to 4)
0.7
(0 to 3)
3.0
(3 to 3)
Sensitization Mean Visualization Score Baseline
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Sensitization Mean Visualization Score Day 35
0.12
(0 to 2)
0.03
(0 to 2)
0.03
(0 to 2)
0
(0 to 0)
0
(0 to 0)
Time Frame Adverse events reported over a 21 (irritation) and 35 (sensitization) day period.
Adverse Event Reporting Description Participants received up to 5 different products simultaneously during the study. Adverse skin reactions with known relationships to the products applied were reported individually. Non-skin related adverse events were also captured during the study but could not be associated directly with a particular treatment and are not included.
 
Arm/Group Title 2% CHG Cloth Vehicle Cloth DynaHex (2% CHG) Saline Sodium Lauryl Sulfate (SLS)
Hide Arm/Group Description

Chlorhexidine Gluconate 2%

2% CHG Cloth: CHG solution on cloth

Excipients on cloth

Vehicle Cloth: Excipients from CHG cloth only

Chlorhexidine Gluconate 2% solution

Active Comparator: 2% CHG solution

0.9% sodium chloride

Saline: Negative control

Sodium lauryl sulfate to produce mild irritation as a positive control

SLS: Provides a slight irritation for a positive control

All-Cause Mortality
2% CHG Cloth Vehicle Cloth DynaHex (2% CHG) Saline Sodium Lauryl Sulfate (SLS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2% CHG Cloth Vehicle Cloth DynaHex (2% CHG) Saline Sodium Lauryl Sulfate (SLS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/249 (0.00%)      0/249 (0.00%)      0/249 (0.00%)      0/249 (0.00%)      0/39 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2% CHG Cloth Vehicle Cloth DynaHex (2% CHG) Saline Sodium Lauryl Sulfate (SLS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/249 (2.01%)      0/249 (0.00%)      15/249 (6.02%)      0/249 (0.00%)      1/39 (2.56%)    
Skin and subcutaneous tissue disorders           
Rash * 1  3/249 (1.20%)  3 0/249 (0.00%)  0 12/249 (4.82%)  12 0/249 (0.00%)  0 0/39 (0.00%)  0
Irritation * 1  2/249 (0.80%)  2 0/249 (0.00%)  0 3/249 (1.20%)  3 0/249 (0.00%)  0 1/39 (2.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Confidential information based on contract
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: C Beausoleil
Organization: Bioscience Labs
Phone: 406-587-5735
EMail: cbeausoleil@bioscience.com
Layout table for additonal information
Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT02224625     History of Changes
Other Study ID Numbers: R13-051
First Submitted: August 20, 2014
First Posted: August 25, 2014
Results First Submitted: February 5, 2016
Results First Posted: May 30, 2016
Last Update Posted: March 9, 2017