Trial Outcomes & Findings for A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray (NCT NCT02106403)

Last Updated: 2015-02-11

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Immediately after product application

Results posted on

2015-02-11

Participant Flow

Partcipants were recruited at one clinical study site in China.

A total of 50 participants with 1:1 ratio of male to female were screened and 50 were randomized.

Participant milestones

Participant milestones
Measure	Sequence 1 Prototype disinfectant spray was sprayed twice on first wound, followed by Reference product twice sprayed on the second wound and subsequently Negative control was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 2 Prototype disinfectant spray was sprayed twice on first wound, followed by Negative control sprayed twice on the second wound and subsequently Reference product was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 3 Reference product was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Negative control sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 4 Reference product was sprayed twice on the first wound, followed by Negative control sprayed twice on the second wound and subsequently prototype disinfectant spray was twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 5 Negative control was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Reference product sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 6 Negative control was sprayed twice on the first wound, followed by Reference product sprayed twice on the second wound and Prototype Disinfectant Spray twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
Visit 1, Treatment Period 1 STARTED	8	8	9	8	8	9
Visit 1, Treatment Period 1 COMPLETED	8	8	9	8	8	9
Visit 1, Treatment Period 1 NOT COMPLETED	0	0	0	0	0	0
Visit 1, Treatment Period 2 STARTED	8	8	9	8	8	9
Visit 1, Treatment Period 2 COMPLETED	8	8	9	8	8	9
Visit 1, Treatment Period 2 NOT COMPLETED	0	0	0	0	0	0
Visit 1, Treatment Period 3 STARTED	8	8	9	8	8	9
Visit 1, Treatment Period 3 COMPLETED	8	8	9	8	8	9
Visit 1, Treatment Period 3 NOT COMPLETED	0	0	0	0	0	0
Follow-Up Visit 2 STARTED	8	8	9	8	8	9
Follow-Up Visit 2 COMPLETED	8	8	9	8	8	9
Follow-Up Visit 2 NOT COMPLETED	0	0	0	0	0	0
Follow-Up Visit 3 STARTED	8	8	9	8	8	9
Follow-Up Visit 3 COMPLETED	8	8	9	8	8	8
Follow-Up Visit 3 NOT COMPLETED	0	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1 Prototype disinfectant spray was sprayed twice on first wound, followed by Reference product twice sprayed on the second wound and subsequently Negative control was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 2 Prototype disinfectant spray was sprayed twice on first wound, followed by Negative control sprayed twice on the second wound and subsequently Reference product was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 3 Reference product was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Negative control sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 4 Reference product was sprayed twice on the first wound, followed by Negative control sprayed twice on the second wound and subsequently prototype disinfectant spray was twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 5 Negative control was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Reference product sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.	Sequence 6 Negative control was sprayed twice on the first wound, followed by Reference product sprayed twice on the second wound and Prototype Disinfectant Spray twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
Follow-Up Visit 3 Other Reason	0	0	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Participants n=50 Participants All randomized participants were evaluated for baseline characteristics
Age, Continuous	40.0 Years STANDARD_DEVIATION 12.32 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after product application

Population: 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

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).

Outcome measures

Outcome measures
Measure	Prototype Disinfectant Spray Formulation n=50 Participants 0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Reference Product n=50 Participants 0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Negative Control n=50 Participants 0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
Participant-perceived Cooling Sensation Immediately Post Product Application	30.63 Score on a scale Standard Error 4.345	30.15 Score on a scale Standard Error 4.345	25.16 Score on a scale Standard Error 4.345

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prototype Disinfectant Spray Formulation n=50 Participants 0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Reference Product n=50 Participants 0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Negative Control n=50 Participants 0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
Participant-perceived Cooling Sensation at 3 Min	39.15 Score on a scale Standard Error 3.726	29.42 Score on a scale Standard Error 3.726	27.73 Score on a scale Standard Error 3.726

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prototype Disinfectant Spray Formulation n=50 Participants 0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Reference Product n=50 Participants 0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Negative Control n=50 Participants 0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
Participant-perceived Cooling Sensation at 5 Min	34.46 Score on a scale Standard Error 3.147	20.14 Score on a scale Standard Error 3.147	22.32 Score on a scale Standard Error 3.147

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prototype Disinfectant Spray Formulation n=50 Participants 0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Reference Product n=50 Participants 0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Negative Control n=50 Participants 0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
Participant-perceived Cooling Sensation at 15 Min	16.84 Score on a scale Standard Error 2.725	12.45 Score on a scale Standard Error 2.725	10.43 Score on a scale Standard Error 2.725

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prototype Disinfectant Spray Formulation n=50 Participants 0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Reference Product n=50 Participants 0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Negative Control n=50 Participants 0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
Overall Sensory Liking of Study Products	6.60 Score on a scale Standard Error 0.199	6.38 Score on a scale Standard Error 0.199	6.22 Score on a scale Standard Error 0.199

Adverse Events

Prototype Disinfectant Spray Formulation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Reference Product

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Negative Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prototype Disinfectant Spray Formulation n=50 participants at risk 0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Reference Product n=50 participants at risk 0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.	Negative Control n=50 participants at risk 0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
Injury, poisoning and procedural complications Itch in all three wounds(Wound Complication)	2.0% 1/50 • AEs were collected from the start of the investigational product, and until last visit (7 days following last administration of the investigational product).	2.0% 1/50 • AEs were collected from the start of the investigational product, and until last visit (7 days following last administration of the investigational product).	2.0% 1/50 • AEs were collected from the start of the investigational product, and until last visit (7 days following last administration of the investigational product).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER