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

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ClinicalTrials.gov Identifier: NCT02106403
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Skin Care Other: Prototype disinfectant spray formulation Other: Reference product Other: Negative control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
Study Start Date : May 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Participant-perceived Cooling Sensation Immediately Post Product Application [ Time Frame: 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).

  2. Participant-perceived Cooling Sensation at 3 Min [ Time Frame: 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.

  3. Participant-perceived Cooling Sensation at 5 Min [ Time Frame: 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.

  4. Participant-perceived Cooling Sensation at 15 Min [ Time Frame: 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.


Secondary Outcome Measures :
  1. Overall Sensory Liking of Study Products [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106403


Locations
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China, Guangdong
Guangzhou Landproof Testing Technology Co., LTD
Guangzhou, Guangdong, China, 510635
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02106403    
Other Study ID Numbers: 202273
RH02332 ( Other Identifier: GSK )
First Posted: April 8, 2014    Key Record Dates
Results First Posted: February 11, 2015
Last Update Posted: February 11, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Disinfectants
Anti-Infective Agents