N/A
N=50
A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
Skin Care
Bottom Line
View on ClinicalTrials.gov: NCT02106403 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Participant-perceived Cooling Sensation Immediately Post Product Application — 30.63; 30.15; 25.16 Score on a scale — p=0.0659
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prototype disinfectant spray formulation (Other); Reference product (Other); Negative control (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant-perceived Cooling Sensation Immediately Post Product Application |
30.63; 30.15; 25.16 | 0.0659 |
| PRIMARY Participant-perceived Cooling Sensation at 3 Min |
39.15; 29.42; 27.73 | 0.0016 sig |
| PRIMARY Participant-perceived Cooling Sensation at 5 Min |
34.46; 20.14; 22.32 | <0.0001 sig |
| PRIMARY Participant-perceived Cooling Sensation at 15 Min |
16.84; 12.45; 10.43 | 0.0357 sig |
| SECONDARY Overall Sensory Liking of Study Products |
6.60; 6.38; 6.22 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02106403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.