Last updated: 11/07/2018 12:32:00

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

GSK study ID
202273
See study documents
Clinicaltrials.gov ID
NCT02106403
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Participant-perceived cooling sensation immediately post product application

Timeframe: Immediately after product application

Participant-perceived cooling sensation at 3 min

Timeframe: At 3 min after product application

Participant-perceived cooling sensation at 5 min

Timeframe: At 5 min after product application

Participant-perceived cooling sensation at 15 min

Timeframe: At 15 min after product application

Secondary outcomes:

Overall sensory liking of study products

Timeframe: Immediatey, 3 min, 5 min and 15 min after product application

Interventions:
Other: Prototype disinfectant spray formulation
Other: Reference product
Other: Negative control
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2014-10-06
Time perspective:
Not applicable
Clinical publications:
Peili Gong , Nan Wang , Lei Guan , Wei Lai, Two randomized studies to evaluate the cooling sensation, consumer liking, and tolerability of a skin disinfectant spray[J]. Journal of the Society of Cosmetic Chemists,2017, Vol. 68, No. 3, 205-218
Medical condition
Skin Care
Product
benzalkonium chloride
Collaborators
Not applicable
Study date(s)
May 2014 to June 2014
Type
Interventional
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
  • Participants in good health with healthy and intact skin on the test area
  • Age 18-60 years
  • Pregnancy or breast-feeding
  • Allergy/Intolerance
Inclusion and exclusion 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

Trial location(s)

Location
Status
Contact us
Contact us
Location
Guangzhou Landproof Testing Technology Co., LTD
Guangzhou, Guangdong, China, 510635
Status
Study Complete
Contact us

Study documents

Statistical analysis plan
Available language(s): English
Download document(s)
Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2014-10-06
Actual study completion date
2014-10-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website