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

NCT02106403 | Completed Results

• 2 other identifiers: 202273RH02332
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Care

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Overall Sensory Liking of Study Products

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

Study Arms (3)

Prototype disinfectant spray formulation

EXPERIMENTAL

0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Other: Prototype disinfectant spray formulation

Reference product

ACTIVE COMPARATOR

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

Other: Reference product

Negative control

PLACEBO COMPARATOR

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

Other: Negative control

Interventions

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

Prototype disinfectant spray formulation

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

Reference product

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

Negative control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants in good health with healthy and intact skin on the test area
• Age 18-60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Guangzhou Landproof Testing Technology Co., LTD

Guangzhou, Guangdong, 510635, China

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 8, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 11, 2015
• Results First Posted: February 11, 2015

Record last verified: 2015-01

Locations

CN (1)