A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray

Study Overview
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Brief Summary
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The objective of this randomised, examiner and subject blinded study is to evaluate and compare cooling performance and overall consumer liking of the prototype formulation with the currently marketed wound spray and negative control in subjects with experimental wounds. For each subject, three superficial wounds will be induced on two volar forearms, by sequential tape strippings until a glistening layer is visualized. After wounding, a randomised test product will be sprayed twice on test site, and the subject will be asked to complete a questionnaire evaluating product cooling performance and overall liking.

Official Title
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A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray

Conditions
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Skin Care

Intervention / Treatment
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* Other: Prototype disinfectant spray formulation
* Other: Reference product
* Other: Negative control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in good health with healthy and intact skin on the test area Age 18-60 years Exclusion Criteria: Pregnancy or breast-feeding Allergy/Intolerance Participants currently taking any topical or systemic treatments that may interfere with or mask the test results Participants who have taken any topical anti-inflammation treatment in the application area in past 2 months Participants who are vulnerable to any intervention Damaged skin close to test site, active skin disorders, any visible skin disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prototype disinfectant spray formulation<br>0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound | Other: Prototype disinfectant spray formulation<br>* 0.13% w/w BAC and 1% MGA. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound<br>|
| Active Comparator: Reference product<br>0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound | Other: Reference product<br>* 0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound<br>|
| Placebo Comparator: Negative control<br>0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound | Other: Negative control<br>* 0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant-perceived Cooling Sensation Immediately Post Product Application | The cooling sensation was assessed immediately after the study product application on 100 millimeter (mm) Visual Analogue Scale (VAS) (0-100 mm, where 0= no cooling and 100= extreme cooling). | Immediately after product application | 
| Participant-perceived Cooling Sensation at 3 Min | The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 3 min post study product application. | At 3 min after product application | 
| Participant-perceived Cooling Sensation at 5 Min | The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 5 min post study product application. | At 5 min after product application | 
| Participant-perceived Cooling Sensation at 15 Min | The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 15 min post study product application. | At 15 min after product application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Sensory Liking of Study Products | Overall sensory liking of the study products was assessed immediately, 3min, 5 min and 15 min after products application. The assessment was done on a 9 point categorical scale where 1= Dislike it extremely, 2= Dislike it very much, 3= Dislike it moderately, 4= Dislike it slightly, 5= Neither like it nor dislike it, 6= Like it slightly, 7= Like it moderately, 8= Like it very much, 9= Like it extremely. | Immediatey, 3 min, 5 min and 15 min after product application |