Wound Healing
Conditions
Brief summary
The aim of the study is to evaluate the irritation potential of benzalkonium chloride disinfectant spray when placed in contact with normal human skin.
Detailed description
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,edema˛ extreme blistering).
Interventions
DRUG0.13% Benzalkonium Chloride
Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution
DRUGSLS Solution
Finn Chamber filled with SLS (0.3% w/v) water solution
DRUGNormal Saline Water
Finn Chamber filled with Normal Saline water (0.9% w/v)
OTHEREmpty Finn Chamber
Empty Finn Chamber
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 2. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions, and will agree to not participate in any other study during the entire length of the study. 3. General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history and vital signs at the screening. 4. Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
Exclusion criteria
1. Pregnancy: Woman who is pregnant or who has a positive urine pregnancy test (just for females of childbearing potential) at the baseline. 2. Breast-feeding: Woman who is breast-feeding. 3. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials or have self-reported sensitive skin or a history of dermal hypersensitivity. 4. 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. 5. Substance abuse: Recent history (within the last 1 year) of alcohol or other substance abuse. 6. Personnel: An employee of the sponsor or the study site or members of their immediate family. 7. Participant who is currently taking any of the following medications: * Any topical or systemic treatments that may mask or interfere with the test results, specifically topical and/or systemic corticosteroids, non steroidal anti-inflammatory drugs (e.g. ibuprofen, aspirin), antihistamines and immunosuppressive in the past 30 days. And those taking medications which in the opinion of the clinical investigator may affect test results. * Topical anti-inflammation treatment in the aimed application area in the past 2 months. 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Skin Irritation Scores at 24 Hours | Baseline to 24 hours following product application | 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. |
| Proportion of Participants With Skin Irritation Scores at 48 Hours | Baseline to 48 hours following first product application | 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. |
| Proportion of Participants With Skin Irritation Scores at 72 Hours | Baseline to 72 hours following first product application | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Irritation Scores at 24 Hours | Baseline to 24 hours following product application | 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. |
| Skin Irritation Scores at 48 Hours | Baseline to 48 hours following first product application | 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. |
| Skin Irritation Scores at 72 Hours | Baseline to 72 hours following first product application | 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. |
Countries
China
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were evaluated for baseline parameters. | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 36.2 Years STANDARD_DEVIATION 12.27 |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
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.
Time frame: Baseline to 24 hours following product application
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 1 (Weak Erythema) | 25.0 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 0 (No Visible Skin Reaction) | 75.0 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 1 (Weak Erythema) | 8.3 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 0 (No Visible Skin Reaction) | 91.7 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 0 (No Visible Skin Reaction) | 94.4 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 1 (Weak Erythema) | 5.6 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 1 (Weak Erythema) | 5.6 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 0 (No Visible Skin Reaction) | 94.4 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 24 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
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.
Time frame: Baseline to 48 hours following first product application
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 1 (Weak Erythema) | 22.2 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 0 (No Visible Skin Reaction) | 77.8 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 2 (Erythema, Infiltration, Papule) | 11.1 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 0 (No Visible Skin Reaction) | 50.0 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 1 (Weak Erythema) | 38.9 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 1 (Weak Erythema) | 0 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 0 (No Visible Skin Reaction) | 100.0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 1 (Weak Erythema) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 48 Hours | Score = 0 (No Visible Skin Reaction) | 100.0 Percentage of participants |
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.
Time frame: Baseline to 72 hours following first product application
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 1 (Weak Erythema) | 16.7 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 2 (Erythema, Infiltration, Papule) | 5.6 Percentage of participants |
| Benzalkonium Chloride Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 0 (No Visible Skin Reaction) | 77.8 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 2 (Erythema, Infiltration, Papule) | 16.7 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 1 (Weak Erythema) | 22.2 Percentage of participants |
| SLS Solution | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 0 (No Visible Skin Reaction) | 61.1 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 0 (No Visible Skin Reaction) | 94.4 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 1 (Weak Erythema) | 5.6 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| Normal Saline Water | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 1 (Weak Erythema) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 0 (No Visible Skin Reaction) | 100.0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Percentage of participants |
| Empty Finn Chamber | Proportion of Participants With Skin Irritation Scores at 72 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Percentage of participants |
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.
Time frame: Baseline to 24 hours following product application
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benzalkonium Chloride Solution | Skin Irritation Scores at 24 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 24 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 24 Hours | Score = 1 (Weak Erythema) | 9 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 24 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 24 Hours | Score = 0 (No Visible Skin Reaction) | 27 Number of participants |
| SLS Solution | Skin Irritation Scores at 24 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Number of participants |
| SLS Solution | Skin Irritation Scores at 24 Hours | Score = 0 (No Visible Skin Reaction) | 24 Number of participants |
| SLS Solution | Skin Irritation Scores at 24 Hours | Score = 1 (Weak Erythema) | 2 Number of participants |
| SLS Solution | Skin Irritation Scores at 24 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Number of participants |
| SLS Solution | Skin Irritation Scores at 24 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Number of participants |
Comparison: Null hypothesis considered no treatment difference between the treatments being compared.p-value: 0.0654Signed Rank Test
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.
Time frame: Baseline to 48 hours following first product application
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benzalkonium Chloride Solution | Skin Irritation Scores at 48 Hours | Score = 1 (Weak Erythema) | 8 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 48 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 48 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 48 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 48 Hours | Score = 0 (No Visible Skin Reaction) | 28 Number of participants |
| SLS Solution | Skin Irritation Scores at 48 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Number of participants |
| SLS Solution | Skin Irritation Scores at 48 Hours | Score = 0 (No Visible Skin Reaction) | 36 Number of participants |
| SLS Solution | Skin Irritation Scores at 48 Hours | Score = 1 (Weak Erythema) | 0 Number of participants |
| SLS Solution | Skin Irritation Scores at 48 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Number of participants |
| SLS Solution | Skin Irritation Scores at 48 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Number of participants |
Comparison: Null hypothesis considered no treatment difference between the treatments being compared.p-value: 0.0078Signed Rank Test
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.
Time frame: Baseline to 72 hours following first product application
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benzalkonium Chloride Solution | Skin Irritation Scores at 72 Hours | Score = 1 (Weak Erythema) | 6 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 72 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 72 Hours | Score = 2 (Erythema, Infiltration, Papule) | 2 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 72 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Number of participants |
| Benzalkonium Chloride Solution | Skin Irritation Scores at 72 Hours | Score = 0 (No Visible Skin Reaction) | 28 Number of participants |
| SLS Solution | Skin Irritation Scores at 72 Hours | Score = 4 (Erythema, Edema, Extreme Blistering) | 0 Number of participants |
| SLS Solution | Skin Irritation Scores at 72 Hours | Score = 0 (No Visible Skin Reaction) | 34 Number of participants |
| SLS Solution | Skin Irritation Scores at 72 Hours | Score = 1 (Weak Erythema) | 2 Number of participants |
| SLS Solution | Skin Irritation Scores at 72 Hours | Score = 2 (Erythema, Infiltration, Papule) | 0 Number of participants |
| SLS Solution | Skin Irritation Scores at 72 Hours | Score = 3 (Erythema, Edema, Papule, Blister) | 0 Number of participants |
Comparison: Null hypothesis considered no treatment difference between the treatments being compared.p-value: 0.0547Signed Rank Test