Trial Outcomes & Findings for A Proof of Concept Clinical Study to Investigate the Effects of an Experimental Cosmetic Moisturiser on the Barrier Function of Human Skin on the Face and Forearm (NCT NCT03216265)

Last Updated: 2019-04-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

69 participants

Primary outcome timeframe

At Baseline and Day 29

Results posted on

2019-04-18

Participant Flow

All participants were enrolled at one center in Germany.

A total of 93 participants were screened, out of which 24 did not meet study criteria. Remaining 69 participants were enrolled in the study, out of which 3 did not start the study. 2 were lost to follow-up and 1 due to other reason (not specified).

Participant milestones

Participant milestones
Measure	No Treatment/ Test Product Participants randomized to this arm applied Test product at allocated side and left other sites untreated.	No Treatment/ Positive Control Participants randomized to this arm applied Positive product at allocated sites and left other side untreated.	Test Product/ Positive Control Participants randomized to this arm applied Test and positive product at allocated side.
Overall Study STARTED	22	22	22
Overall Study COMPLETED	20	21	19
Overall Study NOT COMPLETED	2	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	No Treatment/ Test Product Participants randomized to this arm applied Test product at allocated side and left other sites untreated.	No Treatment/ Positive Control Participants randomized to this arm applied Positive product at allocated sites and left other side untreated.	Test Product/ Positive Control Participants randomized to this arm applied Test and positive product at allocated side.
Overall Study Adverse Event	2	0	2
Overall Study Lost to Follow-up	0	1	0
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

A Proof of Concept Clinical Study to Investigate the Effects of an Experimental Cosmetic Moisturiser on the Barrier Function of Human Skin on the Face and Forearm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Treatment/ Test Product n=22 Participants Participants randomized to this arm applied Test product at allocated side and left other sites untreated.	No Treatment/ Positive Control n=22 Participants Participants randomized to this arm applied Positive product at allocated sites and left other side untreated.	Test Product/ Positive Control n=22 Participants Participants randomized to this arm applied Test and positive product at allocated side.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=93 Participants	22 Participants n=4 Participants	22 Participants n=27 Participants	66 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	22 Participants n=4 Participants	22 Participants n=27 Participants	66 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) White	22 Participants n=93 Participants	22 Participants n=4 Participants	22 Participants n=27 Participants	66 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants

PRIMARY outcome

Timeframe: At Baseline and Day 29

Population: 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.

Outcome measures

Outcome measures
Measure	Test Product n=40 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=42 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 Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated Versus (vs.) Untreated Sites on the Forearm	-0.59 gram (g)/meter(m)^2/hour Standard Deviation 2.005	0.79 gram (g)/meter(m)^2/hour Standard Deviation 1.555	—

SECONDARY outcome

Timeframe: At Baseline and Day 29

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=40 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=42 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 Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated vs. Untreated Sites on the Face	-4.33 g/m^2/hour Standard Deviation 3.729	-3.18 g/m^2/hour Standard Deviation 3.841	—

SECONDARY outcome

Timeframe: At Baseline, Day 1 (30 minutes and 6 hours post study product application), Day 2, 15, and 29

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=44 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 Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 2, change from baseline, forearm	8.65 Corneometry Units Standard Deviation 5.954	1.48 Corneometry Units Standard Deviation 4.310	—
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 1 (30 mins) change from baseline, face	25.12 Corneometry Units Standard Deviation 9.093	-6.96 Corneometry Units Standard Deviation 7.647	—
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 15, change from baseline, face	13.92 Corneometry Units Standard Deviation 9.976	2.50 Corneometry Units Standard Deviation 12.227	—
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 29, change from baseline, face	16.94 Corneometry Units Standard Deviation 10.193	3.81 Corneometry Units Standard Deviation 11.580	—
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 1 (30 mins), change from baseline forearm	14.29 Corneometry Units Standard Deviation 6.227	-3.24 Corneometry Units Standard Deviation 5.556	—
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 1 (6 hours), change from baseline, forearm	10.72 Corneometry Units Standard Deviation 5.174	-0.34 Corneometry Units Standard Deviation 4.908	—
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 15, change from baseline, forearm	12.02 Corneometry Units Standard Deviation 7.149	3.06 Corneometry Units Standard Deviation 5.343	—
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 29, change from baseline, forearm	11.85 Corneometry Units Standard Deviation 8.665	4.50 Corneometry Units Standard Deviation 6.498	—
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 1 (6 hours ), change from baseline, face	13.94 Corneometry Units Standard Deviation 7.634	-1.90 Corneometry Units Standard Deviation 7.152	—
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites Day 2, change from baseline, face	8.88 Corneometry Units Standard Deviation 8.501	-0.45 Corneometry Units Standard Deviation 7.867	—

SECONDARY outcome

Timeframe: At Baseline, Day 2, and 15

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=44 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 Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15 Day 2, change from baseline, forearm	0.08 g/m^2/hour Standard Deviation 1.766	0.48 g/m^2/hour Standard Deviation 1.458	—
Change From Baseline in Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15 Day 15, change from baseline, forearm	-0.23 g/m^2/hour Standard Deviation 2.874	1.07 g/m^2/hour Standard Deviation 2.515	—
Change From Baseline in Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15 Day 2, change from baseline, face	-1.49 g/m^2/hour Standard Deviation 2.624	0.77 g/m^2/hour Standard Deviation 3.969	—
Change From Baseline in Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15 Day 15, change from baseline, face	-4.79 g/m^2/hour Standard Deviation 3.895	-2.37 g/m^2/hour Standard Deviation 4.354	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=43 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=44 Participants Data of this arm included all allotted sides of the face of the participants which were left untreated during the study.
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Corneometry Over Treatment Period AUC1-29, Forearm	10.87 Corneometry units Standard Deviation 5.732	10.20 Corneometry units Standard Deviation 6.043	2.88 Corneometry units Standard Deviation 4.028
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Corneometry Over Treatment Period AUC1-29, Face	14.03 Corneometry units Standard Deviation 7.061	15.90 Corneometry units Standard Deviation 10.719	2.05 Corneometry units Standard Deviation 9.149

SECONDARY outcome

Timeframe: Up to Day 29

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=43 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=44 Participants Data of this arm included all allotted sides of the face of the participants which were left untreated during the study.
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Transepidermal Water Loss (TEWL) Over Treatment Period AUC1-29, Forearm	-0.30 g/m^2/hour Standard Deviation 1.849	-0.42 g/m^2/hour Standard Deviation 1.572	0.82 g/m^2/hour Standard Deviation 1.465
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Transepidermal Water Loss (TEWL) Over Treatment Period AUC1-29, Face	-3.95 g/m^2/hour Standard Deviation 2.950	-3.21 g/m^2/hour Standard Deviation 4.465	-1.67 g/m^2/hour Standard Deviation 2.998

SECONDARY outcome

Timeframe: On Day 29 (including Pre-challenge)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=44 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 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 Change from pre-challenge after 12 discs	5.56 g/m^2/hour Standard Deviation 2.780	8.46 g/m^2/hour Standard Deviation 6.392	—
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 Pre-challenge Day 29	6.96 g/m^2/hour Standard Deviation 1.513	8.33 g/m^2/hour Standard Deviation 2.307	—
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 Change from pre-challenge after 4 discs	2.60 g/m^2/hour Standard Deviation 1.504	3.06 g/m^2/hour Standard Deviation 1.995	—
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 Change from pre-challenge after 8 discs	3.35 g/m^2/hour Standard Deviation 1.662	4.94 g/m^2/hour Standard Deviation 3.564	—

SECONDARY outcome

Timeframe: On Day 29 (including Pre-challenge)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=44 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 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 Pre-challenge Day 29	13.10 g/m^2/hour Standard Deviation 4.424	14.63 g/m^2/hour Standard Deviation 5.698	—
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 Change from pre-challenge after 6 Discs	11.34 g/m^2/hour Standard Deviation 6.102	16.66 g/m^2/hour Standard Deviation 10.636	—
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 Change from pre-challenge after 3 Discs	4.58 g/m^2/hour Standard Deviation 3.261	6.45 g/m^2/hour Standard Deviation 4.531	—
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 Change from pre-challenge after 9 Discs	20.68 g/m^2/hour Standard Deviation 12.242	27.26 g/m^2/hour Standard Deviation 15.987	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Product n=40 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=42 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.
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	173.16 Percent Standard Deviation 44.816	213.89 Percent Standard Deviation 29.648	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Product n=40 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=42 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.
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	84.70 percent of absorption Standard Deviation 23.413	107.75 percent of absorption Standard Deviation 20.999	—

SECONDARY outcome

Timeframe: At Baseline, Day 30, 31, 32, 33 and 34

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=41 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 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 Day 30, Change from baseline, forearm	-0.37 g/m^2/hour Standard Deviation 2.351	1.12 g/m^2/hour Standard Deviation 2.348	—
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 Day 33,Change from baseline, forearm	-0.42 g/m^2/hour Standard Deviation 1.902	1.00 g/m^2/hour Standard Deviation 1.961	—
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 Day 31, Change from baseline, face	-4.26 g/m^2/hour Standard Deviation 4.787	-3.27 g/m^2/hour Standard Deviation 4.112	—
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 Day 32, Change from baseline, face	-3.27 g/m^2/hour Standard Deviation 5.264	-3.05 g/m^2/hour Standard Deviation 4.672	—
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 Day 33, Change from baseline, face	-3.52 g/m^2/hour Standard Deviation 4.781	-3.64 g/m^2/hour Standard Deviation 3.736	—
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 Day 34, Change from baseline, face	-3.52 g/m^2/hour Standard Deviation 4.941	-3.18 g/m^2/hour Standard Deviation 4.035	—
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 Day 31, Change from baseline, forearm	-0.77 g/m^2/hour Standard Deviation 1.986	1.53 g/m^2/hour Standard Deviation 2.804	—
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 Day 32,Change from baseline, forearm	-0.17 g/m^2/hour Standard Deviation 2.322	1.48 g/m^2/hour Standard Deviation 2.110	—
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 Day 34, Change from baseline, forearm	-0.59 g/m^2/hour Standard Deviation 1.889	1.18 g/m^2/hour Standard Deviation 1.927	—
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 Day 30, Change from baseline, face	-4.40 g/m^2/hour Standard Deviation 4.145	-3.18 g/m^2/hour Standard Deviation 3.873	—

SECONDARY outcome

Timeframe: At Day 30, 31, 32, 33, and 34

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=44 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 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 Day 30, change from Day 29, forearm	0.20 g/m^2/hour Standard Deviation 1.970	0.25 g/m^2/hour Standard Deviation 1.696	—
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 Day 34, change from Day 29, forearm	0.03 g/m^2/hour Standard Deviation 1.669	0.37 g/m^2/hour Standard Deviation 1.649	—
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 Day 30, change from Day 29, face	0.10 g/m^2/hour Standard Deviation 3.341	-0.05 g/m^2/hour Standard Deviation 2.000	—
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 Day 31, change from Day 29, face	0.22 g/m^2/hour Standard Deviation 3.807	0.01 g/m^2/hour Standard Deviation 2.833	—
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 Day 32, change from Day 29, face	1.17 g/m^2/hour Standard Deviation 4.399	0.22 g/m^2/hour Standard Deviation 2.941	—
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 Day 34, change from Day 29, face	0.91 g/m^2/hour Standard Deviation 4.047	0.09 g/m^2/hour Standard Deviation 2.594	—
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 Day 31, change from Day 29, forearm	-0.09 g/m^2/hour Standard Deviation 1.494	0.72 g/m^2/hour Standard Deviation 1.885	—
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 Day 32, change from Day 29, forearm	0.45 g/m^2/hour Standard Deviation 1.962	0.67 g/m^2/hour Standard Deviation 1.444	—
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 Day 33, change from Day 29, forearm	0.26 g/m^2/hour Standard Deviation 1.673	0.19 g/m^2/hour Standard Deviation 1.737	—
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 Day 33, change from Day 29, face	1.00 g/m^2/hour Standard Deviation 3.454	-0.41 g/m^2/hour Standard Deviation 2.286	—

SECONDARY outcome

Timeframe: Up to Day 34

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=43 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=44 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 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 Change from baseline in AUCday29-34, forearm	-0.51 g/m^2/hour Standard Deviation 3.033	-0.54 g/m^2/hour Standard Deviation 1.777	1.25 g/m^2/hour Standard Deviation 1.897
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 Change from baseline in AUCday29-34, face	-4.81 g/m^2/hour Standard Deviation 4.329	-3.94 g/m^2/hour Standard Deviation 4.187	-3.21 g/m^2/hour Standard Deviation 3.917

SECONDARY outcome

Timeframe: Up to Day 34

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=43 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=44 Participants Data of this arm included all allotted sides of the face of the participants which were left untreated during the study.
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 Change from Day 29 in AUCday29-34, forearm	0.66 g/m^2/hour Standard Deviation 2.166	0.13 g/m^2/hour Standard Deviation 1.296	0.38 g/m^2/hour Standard Deviation 1.056
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 Change from Day 29 in AUCday29-34, face	0.38 g/m^2/hour Standard Deviation 2.114	0.51 g/m^2/hour Standard Deviation 3.006	-0.13 g/m^2/hour Standard Deviation 1.980

SECONDARY outcome

Timeframe: At Baseline, Day 30, 31, 32, 33, and 34

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=44 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 Corneometry Measurements on Days 30, 31, 32, 33 and 34 in Test Product Treated Site vs. Untreated Site on the Forearm and Face Day 30, change from baseline, forearm	7.11 Corneometry units Standard Deviation 7.862	3.48 Corneometry units Standard Deviation 6.298	—
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 Day 31,change from baseline, face	7.40 Corneometry units Standard Deviation 8.909	0.76 Corneometry units Standard Deviation 10.885	—
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 Day 31,change from baseline, forearm	5.51 Corneometry units Standard Deviation 7.653	3.54 Corneometry units Standard Deviation 6.652	—
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 Day 32,change from baseline, forearm	4.25 Corneometry units Standard Deviation 8.419	2.25 Corneometry units Standard Deviation 6.639	—
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 Day 33,change from baseline, forearm	2.85 Corneometry units Standard Deviation 7.444	1.54 Corneometry units Standard Deviation 6.645	—
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 Day 34,change from baseline, forearm	3.53 Corneometry units Standard Deviation 10.071	1.99 Corneometry units Standard Deviation 8.216	—
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 Day 30,change from baseline, face	9.68 Corneometry units Standard Deviation 8.772	2.35 Corneometry units Standard Deviation 11.473	—
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 Day 32,change from baseline, face	5.93 Corneometry units Standard Deviation 8.382	0.41 Corneometry units Standard Deviation 10.749	—
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 Day 33,change from baseline, face	2.93 Corneometry units Standard Deviation 7.597	-2.38 Corneometry units Standard Deviation 10.834	—
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 Day 34,change from baseline, face	4.76 Corneometry units Standard Deviation 11.119	1.09 Corneometry units Standard Deviation 12.370	—

SECONDARY outcome

Timeframe: At Day 29, 30, 31, 32, 33, and 34

Population: 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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=44 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 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 Day 30, change from Day 29, forearm	-4.44 Corneometry units Standard Deviation 4.913	-1.06 Corneometry units Standard Deviation 5.376	—
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 Day 31,change from Day 29, forearm	-6.37 Corneometry units Standard Deviation 4.788	-1.10 Corneometry units Standard Deviation 3.724	—
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 Day 32,change from Day 29, forearm	-7.72 Corneometry units Standard Deviation 4.903	-2.38 Corneometry units Standard Deviation 5.634	—
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 Day 33,change from Day 29, forearm	-8.63 Corneometry units Standard Deviation 4.716	-3.02 Corneometry units Standard Deviation 5.590	—
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 Day 34,change from Day 29, forearm	-8.43 Corneometry units Standard Deviation 6.539	-2.65 Corneometry units Standard Deviation 6.933	—
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 Day 30,change from Day 29, face	-7.84 Corneometry units Standard Deviation 7.647	-1.57 Corneometry units Standard Deviation 7.307	—
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 Day 31,change from Day 29, face	-9.59 Corneometry units Standard Deviation 7.999	-3.09 Corneometry units Standard Deviation 6.784	—
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 Day 32,change from Day 29, face	-11.28 Corneometry units Standard Deviation 8.316	-3.44 Corneometry units Standard Deviation 7.539	—
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 Day 33,change from Day 29, face	-14.22 Corneometry units Standard Deviation 8.466	-6.15 Corneometry units Standard Deviation 8.095	—
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 Day 34,change from Day 29, face	-12.45 Corneometry units Standard Deviation 11.925	-2.77 Corneometry units Standard Deviation 8.020	—

SECONDARY outcome

Timeframe: Up to Day 34

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=43 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=44 Participants Data of this arm included all allotted sides of the face of the participants which were left untreated during the study.
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 Change from baseline in AUCday29-34, forearm	4.12 Corneometry units Standard Deviation 6.675	4.87 Corneometry units Standard Deviation 7.211	2.65 Corneometry units Standard Deviation 5.999
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 Change from baseline in AUCday29-34, face	7.01 Corneometry units Standard Deviation 10.824	7.21 Corneometry units Standard Deviation 7.427	0.84 Corneometry units Standard Deviation 10.386

SECONDARY outcome

Timeframe: Up to Day 34

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product n=43 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=43 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=44 Participants Data of this arm included all allotted sides of the face of the participants which were left untreated during the study.
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 Change from Day 29 in AUCday29-34, forearm	-5.34 Corneometry units Standard Deviation 3.197	-6.24 Corneometry units Standard Deviation 3.642	-1.81 Corneometry units Standard Deviation 4.065
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 Change from Day 29 in AUCday29-34, face	-11.56 Corneometry units Standard Deviation 6.726	-10.04 Corneometry units Standard Deviation 6.804	-2.99 Corneometry units Standard Deviation 5.586

SECONDARY outcome

Timeframe: At Baseline and Day 29

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.

Outcome measures

Outcome measures
Measure	Test Product n=40 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=42 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 Transepidermal Water Loss (TEWL) Measurements on Day 29 of Positive Control Treated Site vs. Untreated Site on the Forearm.	-1.13 g/m^2/hour Standard Deviation 2.104	0.79 g/m^2/hour Standard Deviation 1.555	—

Adverse Events

Test Product

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Positive Control

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Overall Participants

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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