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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


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
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