| Primary | Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated Versus (vs.) Untreated Sites on the Forearm | TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 seconds (sec), to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was Intent To Treat (ITT) (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29. | Posted | | Mean | Standard Deviation | gram (g)/meter(m)^2/hour | | At Baseline and Day 29 | | | | ID | Title | Description |
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| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.59± 2.005
- OG0010.79± 1.555
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | Analysis model (ANCOVA) included participant as random effect, treatment arm and side of body as fixed effects, and baseline value as covariate. | <0.0001 | | Least Square Mean difference | -1.44 | | | 2-Sided | 95 | -2.10 | -0.78 | | | Difference is the first named treatment adjusted (LS) mean change from baseline (Visit 2) minus the second named treatment adjusted mean change from baseline (Visit 2). | | Other | | |
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| Secondary | Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated vs. Untreated Sites on the Face | TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29. | Posted | | Mean | Standard Deviation | g/m^2/hour | | At Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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| Secondary | Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites | Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements was taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | Corneometry Units | | At Baseline, Day 1 (30 minutes and 6 hours post study product application), Day 2, 15, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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| Secondary | Change From Baseline in Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15 | TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | g/m^2/hour | | At Baseline, Day 2, and 15 | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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| Secondary | Standardised Area Under Curve (AUC1-29) of Change From Baseline in Corneometry Over Treatment Period | Standardised AUC1-29 was calculated for each participant for change from baseline in corneometry on forearms and face over the treatment period; i.e. up to Day 29 using the trapezoidal rule and dividing by the number of days in the period. Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements was taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category. | Posted | | Mean | Standard Deviation | Corneometry units | | Up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | Positive Control |
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| Secondary | Standardised Area Under Curve (AUC1-29) of Change From Baseline in Transepidermal Water Loss (TEWL) Over Treatment Period | Standardised AUC1-29 was calculated for each participant for change from baseline in TEWL on forearms and face over the treatment period; i.e. up to Day 29 using the trapezoidal rule and dividing by the number of days in the period. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category. | Posted | | Mean | Standard Deviation | g/m^2/hour | | Up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | Positive Control | Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study. |
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| Secondary | Change From Pre-challenge in Transepidermal Water Loss (TEWL) Measurements of D-Squame Discs Following 4, 8 and 12 Adhesive Discs Removal From Skin of Both Test Product Treated and Untreated Sites on the Forearm on Day 29 | A series of D-Squame discs were gently smoothed over the designated D-Squame Areas by applying a uniform pressure for 5 secs with a stamp to ensure consistent adhesion to the skin. Each disc was pulled off the skin with one fluent and decisive movement. There were maximum of 12 D-Squame discs (in groups of 4) removed from each forearm repeatedly. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. TEWL was measured pre-challenge and after 4, 8 and 12 discs have been removed from the forearms. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category. | Posted | | Mean | Standard Deviation | g/m^2/hour | | On Day 29 (including Pre-challenge) | | | | ID | Title | Description |
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| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. |
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| Secondary | Change From Pre-challenge in Transepidermal Water Loss (TEWL) Measurements of D-Squame Discs Following 3, 6 and 9 Adhesive Discs Removal From Skin of Both Test Product Treated and Untreated Sites on the Face on Day 29 | A series of D-Squame discs were gently smoothed over the designated D-Squame Areas by applying a uniform pressure for 5 secs with a stamp to ensure consistent adhesion to the skin. Each disc was pulled off the skin with one fluent and decisive movement. There were maximum of 9 D-Squame discs (in groups of 3) removed from the face repeatedly. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. TEWL was measured pre-challenge and after 3, 6 and 9 discs have been removed from the face. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category. | Posted | | Mean | Standard Deviation | g/m^2/hour | | On Day 29 (including Pre-challenge) | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. |
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| Secondary | Protein Analysis (SquameScan) of D-Squame Discs (Total of 12 Adhesive Discs) From Skin of Both Test Product Treated and Untreated Sites on the Forearm on Day 29 | The protein content of each D-Squame disc was analysed using a SquameScan. SquameScan is the instrument used to indirectly measure the protein content extracted from the skin by D-squame tape strips. The determination was performed by measuring the optical absorption of the strip at about 850 nanometres (nm) (infrared light). The value displayed in % was proportionally related to the protein content. The protein content was analysed for each of the discs obtained the D-Squame stripping on the forearms and reported to 2 decimal places. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29. | Posted | | Mean | Standard Deviation | Percent | | On Day 29 | | | | ID | Title | Description |
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| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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| Secondary | Protein Analysis of D-Squame Discs (Total of 9 Adhesive Discs) From Skin of Both Test Product Treated and Untreated Sites on the Face on Day 29 | The protein content of each D-Squame disc was analysed using a SquameScan. SquameScan is the instrument used to indirectly measure the protein content extracted from the skin by D-squame tape strips. The determination was performed by measuring the optical absorption of the strip at about 850 nm (infrared light). The value displayed in % was proportionally related to the protein content. The protein content was analysed for each of the discs obtained the D-Squame stripping on the face and reported to 2 decimal places. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29. | Posted | | Mean | Standard Deviation | percent of absorption | | On Day 29 | | | | ID | Title | Description |
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| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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| Secondary | Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Days 30, 31, 32, 33 and 34 in Test Product Treated vs. Untreated Sites on the Forearm and Face | TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value was established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | g/m^2/hour | | At Baseline, Day 30, 31, 32, 33 and 34 | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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| Secondary | Change From Day 29 in Transepidermal Water Loss (TEWL) Measurements on Days 30, 31, 32, 33 and 34 in Test Product Treated vs. Untreated Sites on the Forearm and Face | TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value was established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | g/m^2/hour | | At Day 30, 31, 32, 33, and 34 | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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| Secondary | Change From Baseline in Standardised Area Under Curve (AUCday 29-34) of Transepidermal Water Loss (TEWL) Over Regression Period (Days 30, 31, 32, 33 and 34) of Forearm and Face, Test Product Treated vs. Untreated Sites | Standardised AUCday29-34 was calculated for each participant for change from baseline in TEWL on forearms and face over the regression period (Day31, 32, 33 and 34) using the trapezoidal rule and dividing by the number of days in the period. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value was established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category. | Posted | | Mean | Standard Deviation | g/m^2/hour | | Up to Day 34 | | | | ID | Title | Description |
|---|
| OG000 | Positive Control | Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study | | OG001 | Test Product | |
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| Secondary | Change From Day 29 in Standardised Area Under Curve (AUCday 29-34) of Transepidermal Water Loss (TEWL) Over Regression Period (Days 30, 31, 32, 33 and 34) of Forearm and Face, Test Product Treated vs. Untreated Sites | Standardised AUCday29-34 was calculated for each participant for change from Day 29 in TEWL on forearms and face over the regression period (Day31, 32, 33 and 34) using the trapezoidal rule and dividing by the number of days in the period. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value was established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category. | Posted | | Mean | Standard Deviation | g/m^2/hour | | Up to Day 34 | | | | ID | Title | Description |
|---|
| OG000 | Positive Control | Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study. | | OG001 | Test Product | |
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| Secondary | Change From Baseline in Corneometry Measurements on Days 30, 31, 32, 33 and 34 in Test Product Treated Site vs. Untreated Site on the Forearm and Face | Corneometry was used to measure the moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements were taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | Corneometry units | | At Baseline, Day 30, 31, 32, 33, and 34 | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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| Secondary | Change From Day 29 in Corneometry Measurements on Days 30, 31, 32, 33 and 34 in Test Product Treated Site vs. Untreated Site on the Forearm and Face | Corneometry was used to measure the moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements were taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | Corneometry units | | At Day 29, 30, 31, 32, 33, and 34 | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Data of this arm included all allotted sides of the face of the participants where test product was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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| Secondary | Standardised Area Under Curve (AUCday29-34) Calculated Using Change From Baseline in Corneometry Over Regression Period (Days 30, 31, 32, 33 and 34) on the Forearm and Face | Standardised AUCday29-34 was calculated for each participant for change from baseline in corneometry on forearms and face over the regression period using the trapezoidal rule and dividing by the number of days in the period. Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements was taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category. | Posted | | Mean | Standard Deviation | Corneometry units | | Up to Day 34 | | | | ID | Title | Description |
|---|
| OG000 | Positive Control | Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study. | | OG001 |
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| Secondary | Standardised AUC Calculated Using Change From Day 29 in Corneometry Over Regression Period (Days 30, 31, 32, 33 and 34) on the Forearm and Face | Standardised AUCday29-34 was calculated for each participant for change from day 29 in corneometry on forearms and face over the regression period using the trapezoidal rule and dividing by the number of days in the period. Corneometry was used to measure the moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements were taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category. | Posted | | Mean | Standard Deviation | Corneometry units | | Up to Day 34 | | | | ID | Title | Description |
|---|
| OG000 | Positive Control | Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study. | | OG001 | Test Product |
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| Secondary | Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29 of Positive Control Treated Site vs. Untreated Site on the Forearm. | TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 seconds were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. | Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29. | Posted | | Mean | Standard Deviation | g/m^2/hour | | At Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Positive Control | Data of this arm included all allotted sides of the face of the participants where positive control was applied during the study. | | OG001 | No Treatment | Data of this arm included all allotted sides of the face of the participants which were left untreated during the study. |
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