Skin Care Clinical Trial
Official title:
A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
Verified date | January 2015 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
China | Guangzhou Landproof Testing Technology Co., LTD | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
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