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
Study complete
Study complete
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
    Primary completion date:
    2014-10-06
    Observational study model:
    Not applicable
    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
    Study complete
    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