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Trial record 45 of 49 for:    Sodium Lauryl Sulfate

Patch Test of Benzalkonium Chloride Disinfectant Spray

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ClinicalTrials.gov Identifier: NCT01762982
Recruitment Status : Completed
First Posted : January 8, 2013
Results First Posted : January 22, 2014
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Wound Healing
Interventions Drug: 0.13% Benzalkonium Chloride
Drug: SLS Solution
Drug: Normal Saline Water
Other: Empty Finn Chamber
Enrollment 36
Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details Of 37 participants screened, 1 did not meet the study criteria. Remaining 36 were randomized to the study. Two negative controls, one positive control and one test product were used simultaneously and inserted into the patch (Finn chamber patch test device) as it was a 4-way split plot design study.
Arm/Group Title Overall
Hide Arm/Group Description This was a 4-way split-plot clinical study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 milliliters (mL) of 0.13% Benazalkonium chloride solution), one positive control [Sodium lauryl sulphate (SLS); 0.03 mL of 0.3% weight by weight (w/w) SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% weight by volume (w/v) normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.
Period Title: Overall Study
Started 36
Received Saline Water 36
Received Benzalkonium Chloride 36
Received SLS 36
Received Empty Finn Chamber 36
Completed 36
Not Completed 0
Arm/Group Title All Randomized Participants
Hide Arm/Group Description All randomized participants were evaluated for baseline parameters.
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
36.2  (12.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
22
  61.1%
Male
14
  38.9%
1.Primary Outcome
Title Proportion of Participants With Skin Irritation Scores at 24 Hours
Hide Description Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.
Time Frame Baseline to 24 hours following product application
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment.
Arm/Group Title Benzalkonium Chloride Solution SLS Solution Normal Saline Water Empty Finn Chamber
Hide Arm/Group Description:
0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
Overall Number of Participants Analyzed 36 36 36 36
Measure Type: Number
Unit of Measure: Percentage of participants
Score = 0 (No Visible Skin Reaction) 75.0 91.7 94.4 94.4
Score = 1 (Weak Erythema) 25.0 8.3 5.6 5.6
Score = 2 (Erythema, Infiltration, Papule) 0 0 0 0
Score = 3 (Erythema, Edema, Papule, Blister) 0 0 0 0
Score = 4 (Erythema, Edema, Extreme Blistering) 0 0 0 0
2.Primary Outcome
Title Proportion of Participants With Skin Irritation Scores at 48 Hours
Hide Description Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.
Time Frame Baseline to 48 hours following first product application
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.
Arm/Group Title Benzalkonium Chloride Solution SLS Solution Normal Saline Water Empty Finn Chamber
Hide Arm/Group Description:
0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
Overall Number of Participants Analyzed 36 36 36 36
Measure Type: Number
Unit of Measure: Percentage of participants
Score = 0 (No Visible Skin Reaction) 77.8 50.0 100.0 100.0
Score = 1 (Weak Erythema) 22.2 38.9 0 0
Score = 2 (Erythema, Infiltration, Papule) 0 11.1 0 0
Score = 3 (Erythema, Edema, Papule, Blister) 0 0 0 0
Score = 4 (Erythema, Edema, Extreme Blistering) 0 0 0 0
3.Primary Outcome
Title Proportion of Participants With Skin Irritation Scores at 72 Hours
Hide Description Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.
Time Frame Baseline to 72 hours following first product application
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.
Arm/Group Title Benzalkonium Chloride Solution SLS Solution Normal Saline Water Empty Finn Chamber
Hide Arm/Group Description:
0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
Overall Number of Participants Analyzed 36 36 36 36
Measure Type: Number
Unit of Measure: Percentage of participants
Score = 0 (No Visible Skin Reaction) 77.8 61.1 94.4 100.0
Score = 1 (Weak Erythema) 16.7 22.2 5.6 0
Score = 2 (Erythema, Infiltration, Papule) 5.6 16.7 0 0
Score = 3 (Erythema, Edema, Papule, Blister) 0 0 0 0
Score = 4 (Erythema, Edema, Extreme Blistering) 0 0 0 0
4.Secondary Outcome
Title Skin Irritation Scores at 24 Hours
Hide Description Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.
Time Frame Baseline to 24 hours following product application
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.
Arm/Group Title Benzalkonium Chloride Solution Normal Saline Water
Hide Arm/Group Description:
0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
Overall Number of Participants Analyzed 36 36
Measure Type: Number
Unit of Measure: Number of participants
Score = 0 (No Visible Skin Reaction) 27 24
Score = 1 (Weak Erythema) 9 2
Score = 2 (Erythema, Infiltration, Papule) 0 0
Score = 3 (Erythema, Edema, Papule, Blister) 0 0
Score = 4 (Erythema, Edema, Extreme Blistering) 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benzalkonium Chloride Solution, Normal Saline Water
Comments Null hypothesis considered no treatment difference between the treatments being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0654
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Skin Irritation Scores at 48 Hours
Hide Description Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.
Time Frame Baseline to 48 hours following first product application
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.
Arm/Group Title Benzalkonium Chloride Solution Normal Saline Water
Hide Arm/Group Description:
0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
Overall Number of Participants Analyzed 36 36
Measure Type: Number
Unit of Measure: Number of participants
Score = 0 (No Visible Skin Reaction) 28 36
Score = 1 (Weak Erythema) 8 0
Score = 2 (Erythema, Infiltration, Papule) 0 0
Score = 3 (Erythema, Edema, Papule, Blister) 0 0
Score = 4 (Erythema, Edema, Extreme Blistering) 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benzalkonium Chloride Solution, Normal Saline Water
Comments Null hypothesis considered no treatment difference between the treatments being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Skin Irritation Scores at 72 Hours
Hide Description Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.
Time Frame Baseline to 72 hours following first product application
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.
Arm/Group Title Benzalkonium Chloride Solution Normal Saline Water
Hide Arm/Group Description:
0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
Overall Number of Participants Analyzed 36 36
Measure Type: Number
Unit of Measure: Number of participants
Score = 0 (No Visible Skin Reaction) 28 34
Score = 1 (Weak Erythema) 6 2
Score = 2 (Erythema, Infiltration, Papule) 2 0
Score = 3 (Erythema, Edema, Papule, Blister) 0 0
Score = 4 (Erythema, Edema, Extreme Blistering) 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benzalkonium Chloride Solution, Normal Saline Water
Comments Null hypothesis considered no treatment difference between the treatments being compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0547
Comments [Not Specified]
Method Signed Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.0
Estimation Comments [Not Specified]
Time Frame Adverse Events were collected from the start of the investigational product and until 5 days following last administration of the investigational product.
Adverse Event Reporting Description This was a 4 way Split-plot design study. Hence, all the treatments were given at the same time so association of any adverse event with one specific treatment was not justifiable.
 
Arm/Group Title Overall Study
Hide Arm/Group Description

This was a 4-way split-plot study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 mL of 0.13% Benazalkonium chloride solution), one positive control [SLS; 0.03 mL of 0.3% w/w SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% w/v normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.

All randomized participants exposed to at least one of the study treatments were evaluated for safety.

All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study
Affected / at Risk (%) # Events
Total   0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Study
Affected / at Risk (%) # Events
Total   3/36 (8.33%)    
Skin and subcutaneous tissue disorders   
Pruritus   3/36 (8.33%)  3
Indicates events were collected by systematic assessment
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01762982     History of Changes
Other Study ID Numbers: RH01379
First Submitted: January 4, 2013
First Posted: January 8, 2013
Results First Submitted: July 25, 2013
Results First Posted: January 22, 2014
Last Update Posted: January 22, 2014