Skin Care
Conditions
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.
Interventions
OTHERPrototype disinfectant spray formulation
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
OTHERReference product
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
OTHERNegative control
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
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant-perceived Cooling Sensation at 15 Min | 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. |
| Participant-perceived Cooling Sensation Immediately Post Product Application | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Sensory Liking of Study Products | 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. |
Countries
China
Participant flow
Recruitment details
Partcipants were recruited at one clinical study site in China.
Pre-assignment details
A total of 50 participants with 1:1 ratio of male to female were screened and 50 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were evaluated for baseline characteristics | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Follow-Up Visit 3 | Other Reason | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 40.0 Years STANDARD_DEVIATION 12.32 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 50 | 1 / 50 | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
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.
Time frame: At 15 min 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Prototype Disinfectant Spray Formulation | Participant-perceived Cooling Sensation at 15 Min | 16.84 Score on a scale | Standard Error 2.725 |
| Reference Product | Participant-perceived Cooling Sensation at 15 Min | 12.45 Score on a scale | Standard Error 2.725 |
| Negative Control | Participant-perceived Cooling Sensation at 15 Min | 10.43 Score on a scale | Standard Error 2.725 |
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.035795% CI: [0.44, 12.38]ANOVA
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.50395% CI: [-3.95, 8]ANOVA
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.148295% CI: [-1.59, 10.36]ANOVA
Primary
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.
Time frame: At 3 min 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Prototype Disinfectant Spray Formulation | Participant-perceived Cooling Sensation at 3 Min | 39.15 Score on a scale | Standard Error 3.726 |
| Reference Product | Participant-perceived Cooling Sensation at 3 Min | 29.42 Score on a scale | Standard Error 3.726 |
| Negative Control | Participant-perceived Cooling Sensation at 3 Min | 27.73 Score on a scale | Standard Error 3.726 |
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.001695% CI: [4.43, 18.42]ANOVA
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.632395% CI: [-5.31, 8.69]ANOVA
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.006995% CI: [2.74, 16.73]ANOVA
Primary
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.
Time frame: At 5 min 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Prototype Disinfectant Spray Formulation | Participant-perceived Cooling Sensation at 5 Min | 34.46 Score on a scale | Standard Error 3.147 |
| Reference Product | Participant-perceived Cooling Sensation at 5 Min | 20.14 Score on a scale | Standard Error 3.147 |
| Negative Control | Participant-perceived Cooling Sensation at 5 Min | 22.32 Score on a scale | Standard Error 3.147 |
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: <0.000195% CI: [6.23, 18.04]ANOVA
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.464595% CI: [-8.09, 3.72]ANOVA
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: <0.000195% CI: [8.41, 20.22]ANOVA
Primary
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).
Time frame: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Prototype Disinfectant Spray Formulation | Participant-perceived Cooling Sensation Immediately Post Product Application | 30.63 Score on a scale | Standard Error 4.345 |
| Reference Product | Participant-perceived Cooling Sensation Immediately Post Product Application | 30.15 Score on a scale | Standard Error 4.345 |
| Negative Control | Participant-perceived Cooling Sensation Immediately Post Product Application | 25.16 Score on a scale | Standard Error 4.345 |
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.065995% CI: [-0.37, 11.29]ANOVA
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.092895% CI: [-0.84, 10.81]ANCOVA
Comparison: The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.p-value: 0.871195% CI: [-5.35, 6.31]ANOVA
Secondary
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.
Time frame: Immediatey, 3 min, 5 min and 15 min 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Prototype Disinfectant Spray Formulation | Overall Sensory Liking of Study Products | 6.60 Score on a scale | Standard Error 0.199 |
| Reference Product | Overall Sensory Liking of Study Products | 6.38 Score on a scale | Standard Error 0.199 |
| Negative Control | Overall Sensory Liking of Study Products | 6.22 Score on a scale | Standard Error 0.199 |