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The aim of the study is to evaluate the irritation potential of benzalkonium chloride disinfectant spray when placed in contact with normal human skin.
Benzalkonium chloride is recognized as safe and effective for short term use as first aid antiseptic drug products. In this study, benzalkonium chloride disinfectant spray will be compared to a positive control, and two negative control for irritancy potential on normal skin according to Chinese Patch Test Guideline (China Health Authority 2002). The skin irritation assessment will characterize the test products individually in terms of symptomatology using a 5-point categorical scale ranging from 0 (no visible reaction) to 4 (Erythema,edemaË› extreme blistering).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Benzalkonium chloride (0.13%) Disinfectant Spray water |
|
| Positive Control | Active Comparator | Sodium lauryl sulfate (SLS) (0.3% weight by weight [w/w]) water solution |
|
| Negative Control 1 | Placebo Comparator | Normal saline water (0.9% weight by volume [w/v]) |
|
| Negative Control 2 | Placebo Comparator | Empty Finn Chamber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.13% Benzalkonium Chloride | Drug | Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Skin Irritation Scores at 24 Hours | 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. | Baseline to 24 hours following product application |
| Proportion of Participants With Skin Irritation Scores at 48 Hours | 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. | Baseline to 48 hours following first product application |
| Proportion of Participants With Skin Irritation Scores at 72 Hours | 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. | Baseline to 72 hours following first product application |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Irritation Scores at 24 Hours | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy: Woman who is pregnant or who has a positive urine pregnancy test (just for females of childbearing potential) at the baseline.
Breast-feeding: Woman who is breast-feeding.
Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials or have self-reported "sensitive skin" or a history of dermal hypersensitivity.
Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit, including those who have taken part in any predictive irritation study or sensitisation test.
Substance abuse: Recent history (within the last 1 year) of alcohol or other substance abuse.
Personnel: An employee of the sponsor or the study site or members of their immediate family.
Participant who is currently taking any of the following medications:
Participant who has a history of any acute or chronic disease that might interfere with or increase the risk on study participation. (e.g., atopic dermatitis/eczema, systemic lupus erythematosus, rheumatoid arthritis, other autoimmune diseases, asthma and other chronic respiratory disease).
10. Participant who has damaged skin in close proximity to test sites (e.g., sunburn, uneven skin pigmentation, tattoos, scars, birthmarks or other disfigurations). And those who are suffering from any active skin disorders, conditions, or any visible skin disease which might be confused with a skin reaction from the test materials.
11. Participant who requires use of any emollient on the upper back throughout the study or who use of any emollient or other skin care product on the upper back in the past 3 days.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PeKing University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants were evaluated for baseline parameters. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Skin Irritation Scores at 24 Hours | 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. | 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. | Posted | Number | Percentage of participants | Baseline to 24 hours following product application |
|
Adverse Events were collected from the start of the investigational product and until 5 days following last administration of the investigational product.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D001548 | Benzalkonium Compounds |
| C067074 | sodium lactobionate sucrose solution |
| ID | Term |
|---|---|
| D050339 | Benzylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| SLS Solution | Drug | Finn Chamber filled with SLS (0.3% w/v) water solution |
|
| Normal Saline Water | Drug | Finn Chamber filled with Normal Saline water (0.9% w/v) |
|
| Empty Finn Chamber | Other | Empty Finn Chamber |
|
| Baseline to 24 hours following product application |
| Skin Irritation Scores at 48 Hours | 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. | Baseline to 48 hours following first product application |
| Skin Irritation Scores at 72 Hours | 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. | Baseline to 72 hours following first product application |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
| OG001 | SLS Solution | 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. |
| OG002 | Normal Saline Water | 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. |
| OG003 | Empty Finn Chamber | Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours. |
|
|
| Secondary | Skin Irritation Scores at 24 Hours | 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. | 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. | Posted | Number | Number of participants | Baseline to 24 hours following product application |
|
|
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| Primary | Proportion of Participants With Skin Irritation Scores at 48 Hours | 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. | 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. | Posted | Number | Percentage of participants | Baseline to 48 hours following first product application |
|
|
|
| Primary | Proportion of Participants With Skin Irritation Scores at 72 Hours | 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. | 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. | Posted | Number | Percentage of participants | Baseline to 72 hours following first product application |
|
|
|
| Secondary | Skin Irritation Scores at 48 Hours | 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. | 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. | Posted | Number | Number of participants | Baseline to 48 hours following first product application |
|
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|
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| Secondary | Skin Irritation Scores at 72 Hours | 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. | 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. | Posted | Number | Number of participants | Baseline to 72 hours following first product application |
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| 0 |
| 36 |
| 3 |
| 36 |
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.
| D009861 |
| Onium Compounds |
| Score = 2 (Erythema, Infiltration, Papule) |
|
| Score = 3 (Erythema, Edema, Papule, Blister) |
|
| Score = 4 (Erythema, Edema, Extreme Blistering) |
|
| Score = 1 (Weak Erythema) |
|
| Score = 2 (Erythema, Infiltration, Papule) |
|
| Score = 3 (Erythema, Edema, Papule, Blister) |
|
| Score = 4 (Erythema, Edema, Extreme Blistering) |
|
| Score = 1 (Weak Erythema) |
|
| Score = 2 (Erythema, Infiltration, Papule) |
|
| Score = 3 (Erythema, Edema, Papule, Blister) |
|
| Score = 4 (Erythema, Edema, Extreme Blistering) |
|
| Score = 2 (Erythema, Infiltration, Papule) |
|
| Score = 3 (Erythema, Edema, Papule, Blister) |
|
| Score = 4 (Erythema, Edema, Extreme Blistering) |
|
| Score = 2 (Erythema, Infiltration, Papule) |
|
| Score = 3 (Erythema, Edema, Papule, Blister) |
|
| Score = 4 (Erythema, Edema, Extreme Blistering) |
|