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

Skin Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106403
• Other study ID #: 202273
• Secondary ID: RH02332
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: January 26, 2015
• Start date: May 2014
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Skin Care

Intervention

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
• 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
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

Locations

Country	Name	City	State
China	Guangzhou Landproof Testing Technology Co., LTD	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

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