Trial Outcomes & Findings for Proof of Concept Anti-ageing Clinical Study in Healthy Subjects (NCT NCT03180645)
NCT ID: NCT03180645
Last Updated: 2019-07-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
At Baseline and Day 29
Results posted on
2019-07-01
Participant Flow
All the participants were enrolled at one center in Germany.
A total of 86 participants were screened, out of which 14 did not meet study criteria, remaining 72 participants were randomized to the study.
Participant milestones
| Measure |
Test Product/ No Treatment
Participants randomized to this arm applied Test product at allocated side and left other side untreated.
|
Test Product/ Positive Control
Participants randomized to this arm applied Test and positive product at allocated sides.
|
Positive Control /No Treatment
Participants randomized to this arm applied Positive product at allocated side and left other side untreated.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Test Product/ No Treatment
Participants randomized to this arm applied Test product at allocated side and left other side untreated.
|
Test Product/ Positive Control
Participants randomized to this arm applied Test and positive product at allocated sides.
|
Positive Control /No Treatment
Participants randomized to this arm applied Positive product at allocated side and left other side untreated.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
Baseline Characteristics
Proof of Concept Anti-ageing Clinical Study in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Test Product/ No Treatment
n=24 Participants
Participants randomized to this arm applied Test product at allocated side and left other side untreated.
|
Test Product/ Positive Control
n=24 Participants
Participants randomized to this arm applied Test and positive product at allocated sides.
|
Positive Control /No Treatment
n=24 Participants
Participants randomized to this arm applied Positive product at allocated side and left other side untreated.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Baseline and Day 29Population: 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.
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).
Outcome measures
| Measure |
Test Product
n=47 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
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
|
-0.12 Micro meter (µm)
Standard Deviation 3.478
|
—
|
SECONDARY outcome
Timeframe: At Baseline and Day 15Population: 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.
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).
Outcome measures
| Measure |
Test Product
n=48 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
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
|
-0.18 µm
Standard Deviation 3.237
|
—
|
SECONDARY outcome
Timeframe: At Baseline, Day 15 and 29Population: 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.
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).
Outcome measures
| Measure |
Test Product
n=46 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
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
|
-0.18 µm
Standard Deviation 3.237
|
—
|
|
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
|
-0.12 µm
Standard Deviation 3.478
|
—
|
SECONDARY outcome
Timeframe: At Baseline, Day 15 and 29Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=48 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29
Day 15
|
-1.92 µm
Standard Deviation 18.864
|
0.97 µm
Standard Deviation 10.508
|
-1.46 µm
Standard Deviation 13.194
|
|
Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29
Day 29
|
-7.01 µm
Standard Deviation 18.395
|
-0.55 µm
Standard Deviation 14.144
|
-1.08 µm
Standard Deviation 15.279
|
SECONDARY outcome
Timeframe: At Baseline, Day 15 and 29Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=48 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29
Day15
|
-0.60 µm
Standard Deviation 4.426
|
0.17 µm
Standard Deviation 2.646
|
-0.08 µm
Standard Deviation 3.291
|
|
Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29
Day 29
|
-1.83 µm
Standard Deviation 4.076
|
-0.21 µm
Standard Deviation 3.354
|
-0.26 µm
Standard Deviation 3.433
|
SECONDARY outcome
Timeframe: At Baseline, Day 15 and 29Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=48 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29
Day 15
|
5.81 µm
Standard Deviation 62.571
|
5.35 µm
Standard Deviation 29.232
|
-2.02 µm
Standard Deviation 33.670
|
|
Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29
Day 29
|
-12.89 µm
Standard Deviation 47.901
|
0.23 µm
Standard Deviation 35.323
|
-3.27 µm
Standard Deviation 35.025
|
SECONDARY outcome
Timeframe: At Baseline, Day 15 and 29Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=48 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
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
|
-0.28 Score on a scale
Standard Deviation 0.544
|
-0.15 Score on a scale
Standard Deviation 0.420
|
|
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
|
-0.58 Score on a scale
Standard Deviation 0.583
|
-0.22 Score on a scale
Standard Deviation 0.664
|
SECONDARY outcome
Timeframe: At Baseline, Day 15 and 29Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=48 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29
Day 15
|
6.12 Instrumental units (I.U)
Standard Deviation 7.566
|
7.13 Instrumental units (I.U)
Standard Deviation 8.238
|
-1.09 Instrumental units (I.U)
Standard Deviation 10.813
|
|
Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29
Day 29
|
8.30 Instrumental units (I.U)
Standard Deviation 8.865
|
10.03 Instrumental units (I.U)
Standard Deviation 10.070
|
1.62 Instrumental units (I.U)
Standard Deviation 10.186
|
SECONDARY outcome
Timeframe: At Baseline and Day 29Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=47 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=45 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
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
Interval 38.6 to 44.43
|
39.54 Percent of improvement ratings
Interval 36.61 to 42.52
|
40.58 Percent of improvement ratings
Interval 37.67 to 43.54
|
SECONDARY outcome
Timeframe: At Baseline, Day 15 and 29Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=48 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29
Day 15
|
0.05 Ratio (unitless)
Standard Deviation 0.132
|
0.01 Ratio (unitless)
Standard Deviation 0.121
|
-0.05 Ratio (unitless)
Standard Deviation 0.104
|
|
Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29
Day 29
|
0.08 Ratio (unitless)
Standard Deviation 0.144
|
0.05 Ratio (unitless)
Standard Deviation 0.139
|
0.03 Ratio (unitless)
Standard Deviation 0.113
|
SECONDARY outcome
Timeframe: At Baseline, Day 15 and 29Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=48 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29
Day 15
|
0.02 Ratio (unitless)
Standard Deviation 0.079
|
0.01 Ratio (unitless)
Standard Deviation 0.075
|
-0.03 Ratio (unitless)
Standard Deviation 0.063
|
|
Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29
Day 29
|
0.03 Ratio (unitless)
Standard Deviation 0.093
|
0.02 Ratio (unitless)
Standard Deviation 0.079
|
0.02 Ratio (unitless)
Standard Deviation 0.067
|
SECONDARY outcome
Timeframe: At Baseline, Day 15 and 29Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=48 Participants
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
No Treatment
n=46 Participants
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
|---|---|---|---|
|
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
|
-5.98 gram (g)/meter^2 (m)/hour
Standard Deviation 4.994
|
-2.02 gram (g)/meter^2 (m)/hour
Standard Deviation 4.713
|
|
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
|
-6.62 gram (g)/meter^2 (m)/hour
Standard Deviation 5.791
|
-3.00 gram (g)/meter^2 (m)/hour
Standard Deviation 4.564
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Positive Control
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
No Treatment
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Overall Participants
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product
n=48 participants at risk
Data of this arm included all allotted sides of the face of the participants where test product was applied during the study.
|
Positive Control
n=48 participants at risk
Data of this arm Included all allotted sides of the face of the participants where positive control was applied during the study.
|
No Treatment
n=48 participants at risk
Data of this arm Included all allotted sides of the face of the participants which were left untreated during the study.
|
Overall Participants
n=72 participants at risk
All randomized participants were included in the baseline assessment and received test product (moisturizing cream), positive control and no treatment.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
12.5%
6/48 • 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.
|
8.3%
4/48 • 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.
|
8.3%
4/48 • 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.
|
9.7%
7/72 • 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.
|
|
Nervous system disorders
BURNING SENSATION
|
0.00%
0/48 • 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.
|
4.2%
2/48 • 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.
|
0.00%
0/48 • 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.
|
2.8%
2/72 • 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.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
2.1%
1/48 • 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.
|
2.1%
1/48 • 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.
|
0.00%
0/48 • 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.
|
1.4%
1/72 • 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.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
2.1%
1/48 • 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.
|
4.2%
2/48 • 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.
|
0.00%
0/48 • 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.
|
2.8%
2/72 • 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.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
2.1%
1/48 • 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.
|
2.1%
1/48 • 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.
|
0.00%
0/48 • 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.
|
1.4%
1/72 • 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.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
2.1%
1/48 • 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.
|
2.1%
1/48 • 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.
|
0.00%
0/48 • 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.
|
1.4%
1/72 • 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.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
2.1%
1/48 • 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.
|
4.2%
2/48 • 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.
|
2.1%
1/48 • 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.
|
2.8%
2/72 • 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.
|
|
Skin and subcutaneous tissue disorders
SKIN TIGHTNESS
|
2.1%
1/48 • 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.
|
2.1%
1/48 • 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.
|
0.00%
0/48 • 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.
|
1.4%
1/72 • 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.
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.1%
1/48 • 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.
|
0.00%
0/48 • 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.
|
2.1%
1/48 • 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.
|
1.4%
1/72 • 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.
|
|
Infections and infestations
OTITIS MEDIA
|
2.1%
1/48 • 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.
|
0.00%
0/48 • 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.
|
2.1%
1/48 • 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.
|
1.4%
1/72 • 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.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/48 • 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.
|
2.1%
1/48 • 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.
|
2.1%
1/48 • 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.
|
1.4%
1/72 • 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.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.2%
2/48 • 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.
|
2.1%
1/48 • 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.
|
2.1%
1/48 • 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.
|
2.8%
2/72 • 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.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/48 • 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.
|
2.1%
1/48 • 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.
|
2.1%
1/48 • 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.
|
1.4%
1/72 • 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.
|
|
Eye disorders
DRY EYE
|
2.1%
1/48 • 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.
|
0.00%
0/48 • 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.
|
2.1%
1/48 • 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.
|
1.4%
1/72 • 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.
|
|
Psychiatric disorders
SLEEP DISORDER
|
2.1%
1/48 • 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.
|
0.00%
0/48 • 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.
|
2.1%
1/48 • 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.
|
1.4%
1/72 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
2.1%
1/48 • 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.
|
0.00%
0/48 • 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.
|
2.1%
1/48 • 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.
|
1.4%
1/72 • 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.
|
|
Injury, poisoning and procedural complications
SCRATCH
|
0.00%
0/48 • 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.
|
0.00%
0/48 • 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.
|
2.1%
1/48 • 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.
|
1.4%
1/72 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER