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

Not Applicable

Completed

• Conditions: Skin Care
• Interventions: Other: Reference product; Other: Negative control; Other: Prototype disinfectant spray formulation

• Registration Number: NCT02106403
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Study Start: 2014-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-01
• Results First Submitted: 2015-01-26
• Results First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Results First Posted: 2015-02-11
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Participants in good health with healthy and intact skin on the test area
• Age 18-60 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference product	Reference product	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
Negative control	Negative control	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
Prototype disinfectant spray formulation	Prototype disinfectant spray formulation	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

Primary Outcome Measures

Name	Time	Method
Participant-perceived Cooling Sensation at 5 Min	At 5 min after product application	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.
Participant-perceived Cooling Sensation at 15 Min	At 15 min after product application	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.
Participant-perceived Cooling Sensation Immediately Post Product Application	Immediately after 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).
Participant-perceived Cooling Sensation at 3 Min	At 3 min after product application	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.

Secondary Outcome Measures

Name	Time	Method
Overall Sensory Liking of Study Products	Immediatey, 3 min, 5 min and 15 min after product application	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.

Trial Locations

Locations (1)

Guangzhou Landproof Testing Technology Co., LTD; 🇨🇳 Guangzhou, Guangdong, China