Skin CareNCT02106403

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

A study testing Prototype disinfectant spray formulation and Reference product in people with Skin Care, run by GlaxoSmithKline at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Skin Care
What is being tested?: Prototype disinfectant spray formulation and Reference product
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteChina
Study dates: May 2014to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

China1 site

Guangzhou Landproof Testing Technology Co., LTD
Guangzhou, Guangdong, 510635

Other trials in China

About this study

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
Being tested: Prototype disinfectant spray formulation, Reference product, Negative control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prototype disinfectant spray formulationOther
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 productOther
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 controlOther
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

Study groups in NCT02106403
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Other: Negative control

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 15 min after product application

Secondary outcomes (1)

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.
Measured: Immediatey, 3 min, 5 min and 15 min after product application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jun 2014

First posted8 Apr 2014 (estimated)
Study startMay 2014
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skin CareStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02106403
Sponsor's protocol ID: 202273
Other IDs: RH02332
Status last verified: Jan 2015
First submitted: 27 Mar 2014
Last updated: 11 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
ClinicalTrials.gov ID: NCT02106403
Acronym / sponsor ID: 202273
Conditions: Skin Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 8 Apr 2014 (estimated)
Results: Posted 11 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Prototype disinfectant spray formulation	Experimental	Other: Prototype disinfectant spray formulation0.13% 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
Reference product	Active comparator	Other: Reference product0.13% 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	Placebo comparator	Other: Negative control0.9% 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

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prototype disinfectant spray formulation0.13% 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	Other	Prototype disinfectant spray formulation
Reference product0.13% 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 control0.9% 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

Primary outcome

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).
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.
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.
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.

1 secondary outcome

Overall Sensory Liking of Study Products
Time frame: Immediatey, 3 min, 5 min and 15 min after product application

Results and safety

Results posted to the registry on 11 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	8	8
Sequence 2	8	8
Sequence 3	9	9
Sequence 4	8	8
Sequence 5	8	8
Sequence 6	9	9

Primary outcome: Participant-perceived Cooling Sensation Immediately Post Product Application

Time frame: Immediately after product application. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Prototype Disinfectant Spray Formulation n = 50	Reference Product n = 50	Negative Control n = 50
Value	30.63 (4.345)	30.15 (4.345)	25.16 (4.345)

Prototype Disinfectant Spray Formulation vs Negative Control: Mean Difference (Net): 5.46 (95% CI -0.37 to 11.29), p = 0.0659, ANOVA
Reference Product vs Negative Control: Mean Difference (Net): 4.99 (95% CI -0.84 to 10.81), p = 0.0928, ANCOVA
Prototype Disinfectant Spray Formulation vs Reference Product: Mean Difference (Net): 0.48 (95% CI -5.35 to 6.31), p = 0.8711, ANOVA

Population analysed: Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population

Primary outcome: Participant-perceived Cooling Sensation at 3 Min

Time frame: At 3 min after product application. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Prototype Disinfectant Spray Formulation n = 50	Reference Product n = 50	Negative Control n = 50
Value	39.15 (3.726)	29.42 (3.726)	27.73 (3.726)

Prototype Disinfectant Spray Formulation vs Negative Control: Mean Difference (Net): 11.43 (95% CI 4.43 to 18.42), p = 0.0016, ANOVA
Reference Product vs Negative Control: Mean Difference (Net): 1.69 (95% CI -5.31 to 8.69), p = 0.6323, ANOVA
Prototype Disinfectant Spray Formulation vs Reference Product: Mean Difference (Net): 9.73 (95% CI 2.74 to 16.73), p = 0.0069, ANOVA

Primary outcome: Participant-perceived Cooling Sensation at 5 Min

Time frame: At 5 min after product application. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Prototype Disinfectant Spray Formulation n = 50	Reference Product n = 50	Negative Control n = 50
Value	34.46 (3.147)	20.14 (3.147)	22.32 (3.147)

Prototype Disinfectant Spray Formulation vs Negative Control: Mean Difference (Net): 12.13 (95% CI 6.23 to 18.04), p <0.0001, ANOVA
Reference Product vs Negative Control: Mean Difference (Net): -2.18 (95% CI -8.09 to 3.72), p = 0.4645, ANOVA
Prototype Disinfectant Spray Formulation vs Reference Product: Mean Difference (Net): 14.32 (95% CI 8.41 to 20.22), p <0.0001, ANOVA

Primary outcome: Participant-perceived Cooling Sensation at 15 Min

Time frame: At 15 min after product application. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Prototype Disinfectant Spray Formulation n = 50	Reference Product n = 50	Negative Control n = 50
Value	16.84 (2.725)	12.45 (2.725)	10.43 (2.725)

Prototype Disinfectant Spray Formulation vs Negative Control: Mean Difference (Net): 6.41 (95% CI 0.44 to 12.38), p = 0.0357, ANOVA
Reference Product vs Negative Control: Mean Difference (Net): 2.02 (95% CI -3.95 to 8.00), p = 0.5030, ANOVA
Prototype Disinfectant Spray Formulation vs Reference Product: Mean Difference (Net): 4.39 (95% CI -1.59 to 10.36), p = 0.1482, ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were collected from the start of the investigational product, and until last visit (7 days following last administration of the investigational product).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prototype Disinfectant Spray Formulation	0 of 50 (0%)	1 of 50 (2%)	Not reported
Reference Product	0 of 50 (0%)	1 of 50 (2%)	Not reported
Negative Control	0 of 50 (0%)	1 of 50 (2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prototype disinfectant spray formulation and Reference product in people with Skin Care, run by GlaxoSmithKline at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant-perceived Cooling Sensation Immediately Post Product Application (time frame: Immediately after product application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02106403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.