Skin Aging
Conditions
Brief summary
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.
Detailed description
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).
Interventions
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).
OTHERNo treatment
No treatment
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form * Good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant and relevant abnormalities in medical history or upon physical examination * Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap \[diaphragm or cervical vault caps\] plus spermicidal agent \[foam, gel, film, cream, suppository\]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that participant * Willingness to actively participate in the study and to attend all scheduled visits * Fitzpatrick phototype I-IV * Visual Clinical Fitzpatrick Wrinkle Score 3- 6 in the eye (crow's feet) area on both sides of the face at screening and baseline * Subjects with self-reported sensitive skin
Exclusion criteria
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study * Women who are breast-feeding * Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g.diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluations * Change in contraception within the last 3 months * Presence of open sores, pimples, cysts, irritated skin, hairs or tattoos at the application site * Active dermatosis (local or disseminated) that might interfere with the results of the study * Considered immune compromised * Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk * Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit * Intention of using any oral or topical steroids * Regular use of inhaled steroids (occasional use is permitted) * Regular use of topical anti-itch medications (occasional use permitted; the product should be applied with an applicator but not to the proposed application areas * Use of any topical drug or medication in the proposed application areas * Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit * Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation * Blepharitis, conjunctivitis, uveitis * Topical ocular treatment within the last month * Aesthetic, cosmetic or dermatological treatment on the face within the last 3 months * Intense sun exposure, Ultra Violet-treatments or tanning salon visit within the last 2 weeks * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients * Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit * Previous participation in this study * Recent history (within the last 5 years) of alcohol or other substance abuse * An employee of the sponsor or the study site or members of their immediate family * A smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29 | At Baseline and 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29 | At Baseline, 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). |
| Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 | At Baseline, 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. |
| Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 | At Baseline, 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. |
| Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 | At Baseline, 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. |
| Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 | At Baseline, 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. |
| Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15 | At Baseline and 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). |
| Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29 | At Baseline and 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. |
| Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 | At Baseline, 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. |
| Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 | At Baseline, 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. |
| Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 | At Baseline, 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. |
| Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 | At Baseline, 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. |
Countries
Germany
Participant flow
Recruitment details
All the participants were enrolled at one center in Germany.
Pre-assignment details
A total of 86 participants were screened, out of which 14 did not meet study criteria, remaining 72 participants were randomized to the study.
Participants by arm
| Arm | Count |
|---|---|
| Test Product/ No Treatment Participants randomized to this arm applied Test product at allocated side and left other side untreated. | 24 |
| Test Product/ Positive Control Participants randomized to this arm applied Test and positive product at allocated sides. | 24 |
| Positive Control /No Treatment Participants randomized to this arm applied Positive product at allocated side and left other side untreated. | 24 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Test Product/ No Treatment | Test Product/ Positive Control | Positive Control /No Treatment | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 24 Participants | 72 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 24 Participants | 24 Participants | 72 Participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 24 Participants | 72 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 | 0 / 48 | 0 / 72 |
| other Total, other adverse events | 12 / 48 | 10 / 48 | 11 / 48 | 17 / 72 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 | 0 / 48 | 0 / 72 |
Outcome results
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).
Time frame: At Baseline and Day 29
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29 | -1.90 Micro meter (µm) | Standard Deviation 4.245 |
| No Treatment | Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29 | -0.12 Micro meter (µm) | Standard Deviation 3.478 |
p-value: 0.063895% CI: [-2.21, 0.06]ANCOVA
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.
Time frame: At Baseline, Day 15 and 29
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 | Day 15 | -0.33 Score on a scale | Standard Deviation 0.559 |
| Test Product | Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 | Day 29 | -0.51 Score on a scale | Standard Deviation 0.688 |
| No Treatment | Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 | Day 15 | -0.28 Score on a scale | Standard Deviation 0.544 |
| No Treatment | Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 | Day 29 | -0.58 Score on a scale | Standard Deviation 0.583 |
| No Treatment | Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 | Day 15 | -0.15 Score on a scale | Standard Deviation 0.42 |
| No Treatment | Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 | Day 29 | -0.22 Score on a scale | Standard Deviation 0.664 |
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.
Time frame: At Baseline, Day 15 and 29
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 | Day 15 | 6.12 Instrumental units (I.U) | Standard Deviation 7.566 |
| Test Product | Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 | Day 29 | 8.30 Instrumental units (I.U) | Standard Deviation 8.865 |
| No Treatment | Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 | Day 15 | 7.13 Instrumental units (I.U) | Standard Deviation 8.238 |
| No Treatment | Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 | Day 29 | 10.03 Instrumental units (I.U) | Standard Deviation 10.07 |
| No Treatment | Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 | Day 15 | -1.09 Instrumental units (I.U) | Standard Deviation 10.813 |
| No Treatment | Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 | Day 29 | 1.62 Instrumental units (I.U) | Standard Deviation 10.186 |
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.
Time frame: At Baseline, Day 15 and 29
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 | Day 15 | 0.02 Ratio (unitless) | Standard Deviation 0.079 |
| Test Product | Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 | Day 29 | 0.03 Ratio (unitless) | Standard Deviation 0.093 |
| No Treatment | Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 | Day 15 | 0.01 Ratio (unitless) | Standard Deviation 0.075 |
| No Treatment | Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 | Day 29 | 0.02 Ratio (unitless) | Standard Deviation 0.079 |
| No Treatment | Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 | Day 15 | -0.03 Ratio (unitless) | Standard Deviation 0.063 |
| No Treatment | Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 | Day 29 | 0.02 Ratio (unitless) | Standard Deviation 0.067 |
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.
Time frame: At Baseline, Day 15 and 29
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 | Day 15 | 0.05 Ratio (unitless) | Standard Deviation 0.132 |
| Test Product | Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 | Day 29 | 0.08 Ratio (unitless) | Standard Deviation 0.144 |
| No Treatment | Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 | Day 15 | 0.01 Ratio (unitless) | Standard Deviation 0.121 |
| No Treatment | Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 | Day 29 | 0.05 Ratio (unitless) | Standard Deviation 0.139 |
| No Treatment | Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 | Day 15 | -0.05 Ratio (unitless) | Standard Deviation 0.104 |
| No Treatment | Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 | Day 29 | 0.03 Ratio (unitless) | Standard Deviation 0.113 |
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).
Time frame: At Baseline, Day 15 and 29
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29 | Day 15 | 0.18 µm | Standard Deviation 2.543 |
| Test Product | Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29 | Day 29 | -0.13 µm | Standard Deviation 3.461 |
| No Treatment | Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29 | Day 15 | -0.18 µm | Standard Deviation 3.237 |
| No Treatment | Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29 | Day 29 | -0.12 µm | Standard Deviation 3.478 |
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).
Time frame: At Baseline and Day 15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15 | -0.65 µm | Standard Deviation 4.487 |
| No Treatment | Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15 | -0.18 µm | Standard Deviation 3.237 |
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.
Time frame: At Baseline, Day 15 and 29
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 | Day 15 | -1.92 µm | Standard Deviation 18.864 |
| Test Product | Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 | Day 29 | -7.01 µm | Standard Deviation 18.395 |
| No Treatment | Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 | Day 15 | 0.97 µm | Standard Deviation 10.508 |
| No Treatment | Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 | Day 29 | -0.55 µm | Standard Deviation 14.144 |
| No Treatment | Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 | Day 15 | -1.46 µm | Standard Deviation 13.194 |
| No Treatment | Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 | Day 29 | -1.08 µm | Standard Deviation 15.279 |
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.
Time frame: At Baseline, Day 15 and 29
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 | Day15 | -0.60 µm | Standard Deviation 4.426 |
| Test Product | Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 | Day 29 | -1.83 µm | Standard Deviation 4.076 |
| No Treatment | Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 | Day15 | 0.17 µm | Standard Deviation 2.646 |
| No Treatment | Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 | Day 29 | -0.21 µm | Standard Deviation 3.354 |
| No Treatment | Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 | Day15 | -0.08 µm | Standard Deviation 3.291 |
| No Treatment | Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 | Day 29 | -0.26 µm | Standard Deviation 3.433 |
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.
Time frame: At Baseline, Day 15 and 29
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 | Day 29 | -12.89 µm | Standard Deviation 47.901 |
| Test Product | Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 | Day 15 | 5.81 µm | Standard Deviation 62.571 |
| No Treatment | Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 | Day 15 | 5.35 µm | Standard Deviation 29.232 |
| No Treatment | Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 | Day 29 | 0.23 µm | Standard Deviation 35.323 |
| No Treatment | Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 | Day 15 | -2.02 µm | Standard Deviation 33.67 |
| No Treatment | Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 | Day 29 | -3.27 µm | Standard Deviation 35.025 |
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.
Time frame: At Baseline, Day 15 and 29
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 | Day 15 | -4.17 gram (g)/meter^2 (m)/hour | Standard Deviation 4.904 |
| Test Product | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 | Day 29 | -5.18 gram (g)/meter^2 (m)/hour | Standard Deviation 3.719 |
| No Treatment | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 | Day 15 | -5.98 gram (g)/meter^2 (m)/hour | Standard Deviation 4.994 |
| No Treatment | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 | Day 29 | -6.62 gram (g)/meter^2 (m)/hour | Standard Deviation 5.791 |
| No Treatment | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 | Day 15 | -2.02 gram (g)/meter^2 (m)/hour | Standard Deviation 4.713 |
| No Treatment | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 | Day 29 | -3.00 gram (g)/meter^2 (m)/hour | Standard Deviation 4.564 |
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.
Time frame: At Baseline and Day 29
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Product | Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29 | 41.49 Percent of improvement ratings |
| No Treatment | Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29 | 39.54 Percent of improvement ratings |
| No Treatment | Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29 | 40.58 Percent of improvement ratings |