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

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.

Study Overview

• Status: Completed
• Conditions: Skin Care
• Intervention / Treatment: Other: Prototype disinfectant spray formulation; Other: Reference product; Other: Negative control

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510635
      • Guangzhou Landproof Testing Technology Co., LTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Prototype disinfectant spray formulation; 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
Active Comparator: 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	Other: 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
Placebo Comparator: 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	Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): February 11, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Disinfectants
• Other Study ID Numbers: 202273; RH02332 (Other Identifier: GSK)