An interventional study of Test product (Moisturising cream) and Positive control (Commercial market place moisturising cream) in Skin Aging, sponsored by GlaxoSmithKline. Completed at 1 site in Germany. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-01.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
Participants randomized to this arm will apply Test product at allocated sites and leave other sites untreated.
Other: Test product (Moisturising cream) · Other: No treatment
Participants randomized to this arm will apply Test and positive product at allocated sites.
Other: Test product (Moisturising cream) · Other: Positive control (Commercial market place moisturising cream)
Participants randomized to this arm will apply Positive product at allocated sites and leave other sites untreated.
Other: Positive control (Commercial market place moisturising cream) · Other: No treatment
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).
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
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).
Time frame: At Baseline and Day 29
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Baseline, Day 15 and 29
All the participants were enrolled at one center in Germany.
| Milestone | Test Product/ No Treatment | Test Product/ Positive Control | Positive Control /No Treatment |
|---|---|---|---|
| Started | 24 | 24 | 24 |
| Completed | 24 | 23 | 22 |
| Not completed | 0 | 1 | 2 |
| Withdrew: Adverse event | 0 | 1 | 2 |
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).
| Micro meter (µm) | Test Product | No Treatment |
|---|---|---|
| Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29 | -1.90 ± 4.245 | -0.12 ± 3.478 |
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).
| µm | Test Product | No Treatment |
|---|---|---|
| Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15 | -0.65 ± 4.487 | -0.18 ± 3.237 |
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).
| µm | Positive Control | No Treatment |
|---|---|---|
| Day 15 | 0.18 ± 2.543 | -0.18 ± 3.237 |
| Day 29 | -0.13 ± 3.461 | -0.12 ± 3.478 |
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.
| µm | Test Product | Positive Control | No Treatment |
|---|---|---|---|
| Day 15 | -1.92 ± 18.864 | 0.97 ± 10.508 | -1.46 ± 13.194 |
| Day 29 | -7.01 ± 18.395 | -0.55 ± 14.144 | -1.08 ± 15.279 |
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.
| µm | Test Product | Positive Control | No Treatment |
|---|---|---|---|
| Day15 | -0.60 ± 4.426 | 0.17 ± 2.646 | -0.08 ± 3.291 |
| Day 29 | -1.83 ± 4.076 | -0.21 ± 3.354 | -0.26 ± 3.433 |
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.
| µm | Test Product | Positive Control | No Treatment |
|---|---|---|---|
| Day 15 | 5.81 ± 62.571 | 5.35 ± 29.232 | -2.02 ± 33.670 |
| Day 29 | -12.89 ± 47.901 | 0.23 ± 35.323 | -3.27 ± 35.025 |
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.
| Score on a scale | Test Product | Positive Control | No Treatment |
|---|---|---|---|
| Day 15 | -0.33 ± 0.559 | -0.28 ± 0.544 | -0.15 ± 0.420 |
| Day 29 | -0.51 ± 0.688 | -0.58 ± 0.583 | -0.22 ± 0.664 |
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.
| Instrumental units (I.U) | Test Product | Positive Control | No Treatment |
|---|---|---|---|
| Day 15 | 6.12 ± 7.566 | 7.13 ± 8.238 | -1.09 ± 10.813 |
| Day 29 | 8.30 ± 8.865 | 10.03 ± 10.070 | 1.62 ± 10.186 |
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.
| Percent of improvement ratings | Test Product | Positive Control | Negative Control |
|---|---|---|---|
| Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29 | 41.49 (38.60 to 44.43) | 39.54 (36.61 to 42.52) | 40.58 (37.67 to 43.54) |
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.
| Ratio (unitless) | Test Product | Positive Control | No Treatment |
|---|---|---|---|
| Day 15 | 0.05 ± 0.132 | 0.01 ± 0.121 | -0.05 ± 0.104 |
| Day 29 | 0.08 ± 0.144 | 0.05 ± 0.139 | 0.03 ± 0.113 |
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.
| Ratio (unitless) | Test Product | Positive Control | No Treatment |
|---|---|---|---|
| Day 15 | 0.02 ± 0.079 | 0.01 ± 0.075 | -0.03 ± 0.063 |
| Day 29 | 0.03 ± 0.093 | 0.02 ± 0.079 | 0.02 ± 0.067 |
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.
| gram (g)/meter^2 (m)/hour | Test Product | Positive Control | No Treatment |
|---|---|---|---|
| Day 15 | -4.17 ± 4.904 | -5.98 ± 4.994 | -2.02 ± 4.713 |
| Day 29 | -5.18 ± 3.719 | -6.62 ± 5.791 | -3.00 ± 4.564 |
Collected over Approximately 30 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Product | 0/48 (0%) | 0/48 (0%) | 12/48 (25%) |
| Positive Control | 0/48 (0%) | 0/48 (0%) | 10/48 (20.8%) |
| No Treatment | 0/48 (0%) | 0/48 (0%) | 11/48 (22.9%) |
| Overall Participants | 0/72 (0%) | 0/72 (0%) | 17/72 (23.6%) |
| Event | Test Product | Positive Control | No Treatment | Overall Participants |
|---|---|---|---|---|
| HeadacheNervous system disorders | 6/48 | 4/48 | 4/48 | 7/72 |
| BURNING SENSATIONNervous system disorders | 0/48 | 2/48 | 0/48 | 2/72 |
| ERYTHEMASkin and subcutaneous tissue disorders | 1/48 | 2/48 | 0/48 | 2/72 |
| SKIN EXFOLIATIONSkin and subcutaneous tissue disorders | 1/48 | 2/48 | 1/48 | 2/72 |
| BACK PAINMusculoskeletal and connective tissue disorders | 2/48 | 1/48 | 1/48 | 2/72 |
| DRY SKINSkin and subcutaneous tissue disorders | 1/48 | 1/48 | 0/48 | 1/72 |
| PRURITUSSkin and subcutaneous tissue disorders | 1/48 | 1/48 | 0/48 | 1/72 |
| RASH PAPULARSkin and subcutaneous tissue disorders | 1/48 | 1/48 | 0/48 | 1/72 |
| SKIN TIGHTNESSSkin and subcutaneous tissue disorders | 1/48 | 1/48 | 0/48 | 1/72 |
| NASOPHARYNGITISInfections and infestations | 1/48 | 0/48 | 1/48 | 1/72 |
Safety population (N=72), included all participants who applied any of the study products.
| Age, Categorical(Participants) | Test Product/ No Treatment | Test Product/ Positive Control | Positive Control /No Treatment | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 24 | 24 | 72 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Test Product/ No Treatment | Test Product/ Positive Control | Positive Control /No Treatment | Total |
|---|---|---|---|---|
| Female | 24 | 24 | 24 | 72 |
| Male | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Test Product/ No Treatment | Test Product/ Positive Control | Positive Control /No Treatment | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 24 | 24 | 24 | 72 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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