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The objective of this POC clinical study is to evaluate the moisturising effects on fine lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks of twice daily application of the test product on participants presenting visible signs of ageing.
Participants who meet all the inclusion/exclusion criteria will be randomised to one of three treatment groups: test product/positive control, test product/no treatment or positive control/no treatment at the baseline visit. Product application within treatment group will be further randomised to either the right or left side of the face. Participants will apply one of the assigned treatments to one side of the face (left or right) and another assigned treatment to the other side of the face as per the randomisation schedule. Participants will be instructed to apply the assigned treatments twice daily (morning and evening, approximately 8-12 hours apart) for 4 weeks (28 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product/ No treatment | Other | Participants randomized to this arm will apply Test product at allocated sites and leave other sites untreated. |
|
| Test product/ Positive control | Other | Participants randomized to this arm will apply Test and positive product at allocated sites. |
|
| Positive control /No treatment | Other | Participants randomized to this arm will apply Positive product at allocated sites and leave other sites untreated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product (Moisturising cream) | Other | Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29 | Using fringe projection and optical triangulation techniques, the 3D (three dimensional) surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights). | At Baseline and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Schenefeld | Schleswig-Holstein | 22869 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30414275 | Derived | Nisbet S, Mahalingam H, Gfeller CF, Biggs E, Lucas S, Thompson M, Cargill MR, Moore D, Bielfeldt S. Cosmetic benefit of a biomimetic lamellar cream formulation on barrier function or the appearance of fine lines and wrinkles in randomized proof-of-concept clinical studies. Int J Cosmet Sci. 2019 Feb;41(1):1-11. doi: 10.1111/ics.12499. Epub 2019 Feb 22. |
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A total of 86 participants were screened, out of which 14 did not meet study criteria, remaining 72 participants were randomized to the study.
All the participants were enrolled at one center in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product/ No Treatment | Participants randomized to this arm applied Test product at allocated side and left other side untreated. |
| FG001 | Test Product/ Positive Control | Participants randomized to this arm applied Test and positive product at allocated sides. |
| FG002 | Positive Control /No Treatment | Participants randomized to this arm applied Positive product at allocated side and left other side untreated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population (N=72), included all participants who applied any of the study products.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product/ No Treatment | Participants randomized to this arm applied Test product at allocated side and left other side untreated. |
| BG001 | Test Product/ Positive Control | Participants randomized to this arm applied Test and positive product at allocated sides. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29 | Using fringe projection and optical triangulation techniques, the 3D (three dimensional) surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights). | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. | Posted | Mean | Standard Deviation | Micro meter (µm) | At Baseline and Day 29 |
|
Approximately 30 days
All treatment emergent adverse events (AEs) were reported in this section. Skin-related AEs counted under one or both treatment groups that the subject received based on the application site(s). Non-skin related adverse events counted under both treatment groups that the subject received. Each adverse event was counted only once in the Overall column irrespective of whether it was skin related or not.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2017 | Mar 14, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2017 | Mar 14, 2018 | SAP_001.pdf |
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| Positive control (Commercial market place moisturising cream) | Other | Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening). |
|
| No treatment | Other | No treatment |
|
| At Baseline and Day 15 |
| Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra is the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights). | At Baseline, Day 15 and 29 |
| Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Rz usually used for wrinkle assessments, representing the rough structure, such as wrinkles. Rz was an average of the 5 sub-profiles (peak to valley heights) local maximum. From each local profile the peak to peak height value is calculated; the average of the 5 peak to peak height values was Rz. | At Baseline, Day 15 and 29 |
| Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Sa was the arithmetic average of the absolute (non- signed) heights of the topography points. Sa was the 3D Area -Equivalent of 2D profile roughness parameter Ra. | At Baseline, Day 15 and 29 |
| Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Stm was an average of the 5x5 sub-areas (peak to valley heights) local maximum: The surface was virtually divided into 25 sub-surfaces (5 rows, 5 columns); from each local surface the peak to peak height value is calculated; the average of the 25 peak to height values was Stm. | At Baseline, Day 15 and 29 |
| Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 | A blinded, trained and qualified examiner performed Clinical Fitzpatrick Wrinkle Score assessments by visually grading the crow's feet area under standard conditions of illumination. Fitzpatrick Wrinkle Scores range between 1-9 where 1-3= Fine wrinkles, 4-6= Fine to moderate depth wrinkles, a moderate number of wrinkles, 7-9= Fine to deep wrinkles, numerous lines, with or without redundant skin folds. Low value indicated better results. | At Baseline, Day 15 and 29 |
| Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 | Measurement of Stratum Corneum (SC) hydration was performed by the electrical capacitance method with a Corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. An electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturisation was measured. Higher value of corneometery indicates high moisture content. | At Baseline, Day 15 and 29 |
| Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29 | High resolution images of the left and right side of each participant's whole half-face were taken at baseline and Day 29. Each blinded image pair was randomly displayed on a color-calibrated screen and assessed by a panel of lay graders, who ranked each image based on texture, defined as pores, smoothness and unevenness, on a scale of: 1 = better; or 2 = worse (lower score indicated improvement). The total proportion of improvement (from all lay graders) on Day 29 than baseline is reported for this endpoint. | At Baseline and Day 29 |
| Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 | The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) was displayed as curves (penetration depth in mm/time) in real time during the measurement. This measurement principle provides information about the elastic and mechanical properties of the skin surface and enables objective quantification of skin ageing. R5 (net elasticity): the elastic portion of the suction part versus the elastic portion of the relaxation part. | At Baseline, Day 15 and 29 |
| Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 | The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the measurement. This measurement principle provides information about the elastic and mechanical properties of the skin surface and enables objective quantification of skin ageing. R7: Portion of the elasticity compared to the complete curve values. | At Baseline, Day 15 and 29 |
| Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 | TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors (temperature and relative humidity) placed at different distances perpendicularly to the skin. Measurements were taken in triplicate and then an average (mean) reading was calculated on the left and right Sub-ocular/ Cheek Area directly from the corner of the eyes onto the middle of the cheekbone. A decrease in TEWL corresponds to an improved skin barrier function. | At Baseline, Day 15 and 29 |
| BG002 | Positive Control /No Treatment | Participants randomized to this arm applied Positive product at allocated side and left other side untreated. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
| OG001 | No Treatment | Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study. |
|
|
|
| Secondary | Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights). | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. | Posted | Mean | Standard Deviation | µm | At Baseline and Day 15 |
|
|
|
| Secondary | Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra is the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights). | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | Mean | Standard Deviation | µm | At Baseline, Day 15 and 29 |
|
|
|
| Secondary | Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Rz usually used for wrinkle assessments, representing the rough structure, such as wrinkles. Rz was an average of the 5 sub-profiles (peak to valley heights) local maximum. From each local profile the peak to peak height value is calculated; the average of the 5 peak to peak height values was Rz. | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | Mean | Standard Deviation | µm | At Baseline, Day 15 and 29 |
|
|
|
| Secondary | Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Sa was the arithmetic average of the absolute (non- signed) heights of the topography points. Sa was the 3D Area -Equivalent of 2D profile roughness parameter Ra. | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | Mean | Standard Deviation | µm | At Baseline, Day 15 and 29 |
|
|
|
| Secondary | Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 | Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Stm was an average of the 5x5 sub-areas (peak to valley heights) local maximum: The surface was virtually divided into 25 sub-surfaces (5 rows, 5 columns); from each local surface the peak to peak height value is calculated; the average of the 25 peak to height values was Stm. | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | Mean | Standard Deviation | µm | At Baseline, Day 15 and 29 |
|
|
|
| Secondary | Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 | A blinded, trained and qualified examiner performed Clinical Fitzpatrick Wrinkle Score assessments by visually grading the crow's feet area under standard conditions of illumination. Fitzpatrick Wrinkle Scores range between 1-9 where 1-3= Fine wrinkles, 4-6= Fine to moderate depth wrinkles, a moderate number of wrinkles, 7-9= Fine to deep wrinkles, numerous lines, with or without redundant skin folds. Low value indicated better results. | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline, Day 15 and 29 |
|
|
|
| Secondary | Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 | Measurement of Stratum Corneum (SC) hydration was performed by the electrical capacitance method with a Corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. An electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturisation was measured. Higher value of corneometery indicates high moisture content. | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | Mean | Standard Deviation | Instrumental units (I.U) | At Baseline, Day 15 and 29 |
|
|
|
| Secondary | Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29 | High resolution images of the left and right side of each participant's whole half-face were taken at baseline and Day 29. Each blinded image pair was randomly displayed on a color-calibrated screen and assessed by a panel of lay graders, who ranked each image based on texture, defined as pores, smoothness and unevenness, on a scale of: 1 = better; or 2 = worse (lower score indicated improvement). The total proportion of improvement (from all lay graders) on Day 29 than baseline is reported for this endpoint. | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. | Posted | Number | 95% Confidence Interval | Percent of improvement ratings | At Baseline and Day 29 |
|
|
|
| Secondary | Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 | The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) was displayed as curves (penetration depth in mm/time) in real time during the measurement. This measurement principle provides information about the elastic and mechanical properties of the skin surface and enables objective quantification of skin ageing. R5 (net elasticity): the elastic portion of the suction part versus the elastic portion of the relaxation part. | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | Mean | Standard Deviation | Ratio (unitless) | At Baseline, Day 15 and 29 |
|
|
|
| Secondary | Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 | The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the measurement. This measurement principle provides information about the elastic and mechanical properties of the skin surface and enables objective quantification of skin ageing. R7: Portion of the elasticity compared to the complete curve values. | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | Mean | Standard Deviation | Ratio (unitless) | At Baseline, Day 15 and 29 |
|
|
|
| Secondary | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 | TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors (temperature and relative humidity) placed at different distances perpendicularly to the skin. Measurements were taken in triplicate and then an average (mean) reading was calculated on the left and right Sub-ocular/ Cheek Area directly from the corner of the eyes onto the middle of the cheekbone. A decrease in TEWL corresponds to an improved skin barrier function. | Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | Mean | Standard Deviation | gram (g)/meter^2 (m)/hour | At Baseline, Day 15 and 29 |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 12 |
| 48 |
| EG001 | Positive Control | Data of this arm Included all allotted sides of the face of the participants where positive control was applied during the study. | 0 | 48 | 0 | 48 | 10 | 48 |
| EG002 | No Treatment | Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study. | 0 | 48 | 0 | 48 | 11 | 48 |
| EG003 | Overall Participants | All randomized participants were included in the baseline assessment and received test product (moisturizing cream), positive control and no treatment. | 0 | 72 | 0 | 72 | 17 | 72 |
| BURNING SENSATION | Nervous system disorders | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| RASH PAPULAR | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| SKIN TIGHTNESS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | Systematic Assessment |
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| OTITIS MEDIA | Infections and infestations | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| DRY EYE | Eye disorders | Systematic Assessment |
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| SLEEP DISORDER | Psychiatric disorders | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| SCRATCH | Injury, poisoning and procedural complications | Systematic Assessment |
|
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.
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