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Completed

NCT Number: NCT02106403

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

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.

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Key information

Conditions

Skin Care

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Landproof Testing Technology Co., LTD

Guangzhou, Guangdong, 510635, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prototype disinfectant spray formulation

Other

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

Other

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

Other

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

Primary outcomes

  1. Participant-perceived Cooling Sensation Immediately Post Product Application

    Time frame: Immediately after 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).

  2. Participant-perceived Cooling Sensation at 3 Min

    Time frame: At 3 min after product application

    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.

  3. Participant-perceived Cooling Sensation at 5 Min

    Time frame: At 5 min after product application

    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.

  4. Participant-perceived Cooling Sensation at 15 Min

    Time frame: At 15 min after product application

    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.

Secondary outcomes

  1. Overall Sensory Liking of Study Products

    Time frame: Immediatey, 3 min, 5 min and 15 min after product application

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2014
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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