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
CompletedNAResults postedLast updated 18 April 2019
What this trial tests
NA trial testing Test product (Moisturising cream) in Skin Care in 69 participants. Completed in 24 April 2017.
Adults 18 to 65, female only, with Skin Care. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated Versus (vs.) Untreated Sites on the ForearmPrimary· 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 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.
Group
Value
95% CI
Test Product
-0.59
± 2.005
No Treatment
0.79
± 1.555
Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated vs. Untreated Sites on the FaceSecondary· 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 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.
Group
Value
95% CI
Test Product
-4.33
± 3.729
No Treatment
-3.18
± 3.841
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated SitesSecondary· At Baseline, Day 1 (30 minutes and 6 hours post study product application), Day 2, 15, and 29
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 incr
Day 1 (30 mins), change from baseline forearm
Group
Value
95% CI
Test Product
14.29
± 6.227
No Treatment
-3.24
± 5.556
Day 1 (6 hours), change from baseline, forearm
Group
Value
95% CI
Test Product
10.72
± 5.174
No Treatment
-0.34
± 4.908
Day 2, change from baseline, forearm
Group
Value
95% CI
Test Product
8.65
± 5.954
No Treatment
1.48
± 4.310
Day 15, change from baseline, forearm
Group
Value
95% CI
Test Product
12.02
± 7.149
No Treatment
3.06
± 5.343
Day 29, change from baseline, forearm
Group
Value
95% CI
Test Product
11.85
± 8.665
No Treatment
4.50
± 6.498
Day 1 (30 mins) change from baseline, face
Group
Value
95% CI
Test Product
25.12
± 9.093
No Treatment
-6.96
± 7.647
Day 1 (6 hours ), change from baseline, face
Group
Value
95% CI
Test Product
13.94
± 7.634
No Treatment
-1.90
± 7.152
Day 2, change from baseline, face
Group
Value
95% CI
Test Product
8.88
± 8.501
No Treatment
-0.45
± 7.867
Change From Baseline in Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15Secondary· At Baseline, 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.
Day 2, change from baseline, forearm
Group
Value
95% CI
Test Product
0.08
± 1.766
No Treatment
0.48
± 1.458
Day 15, change from baseline, forearm
Group
Value
95% CI
Test Product
-0.23
± 2.874
No Treatment
1.07
± 2.515
Day 2, change from baseline, face
Group
Value
95% CI
Test Product
-1.49
± 2.624
No Treatment
0.77
± 3.969
Day 15, change from baseline, face
Group
Value
95% CI
Test Product
-4.79
± 3.895
No Treatment
-2.37
± 4.354
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Corneometry Over Treatment PeriodSecondary· Up to Day 29
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 dielectri
AUC1-29, Forearm
Group
Value
95% CI
Test Product
10.87
± 5.732
Positive Control
10.20
± 6.043
No Treatment
2.88
± 4.028
AUC1-29, Face
Group
Value
95% CI
Test Product
14.03
± 7.061
Positive Control
15.90
± 10.719
No Treatment
2.05
± 9.149
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Transepidermal Water Loss (TEWL) Over Treatment PeriodSecondary· Up to Day 29
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 pha
AUC1-29, Forearm
Group
Value
95% CI
Test Product
-0.30
± 1.849
Positive Control
-0.42
± 1.572
No Treatment
0.82
± 1.465
AUC1-29, Face
Group
Value
95% CI
Test Product
-3.95
± 2.950
Positive Control
-3.21
± 4.465
No Treatment
-1.67
± 2.998
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 29Secondary· On Day 29 (including Pre-challenge)
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
Pre-challenge Day 29
Group
Value
95% CI
Test Product
6.96
± 1.513
No Treatment
8.33
± 2.307
Change from pre-challenge after 4 discs
Group
Value
95% CI
Test Product
2.60
± 1.504
No Treatment
3.06
± 1.995
Change from pre-challenge after 8 discs
Group
Value
95% CI
Test Product
3.35
± 1.662
No Treatment
4.94
± 3.564
Change from pre-challenge after 12 discs
Group
Value
95% CI
Test Product
5.56
± 2.780
No Treatment
8.46
± 6.392
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 29Secondary· On Day 29 (including Pre-challenge)
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 ensu
Pre-challenge Day 29
Group
Value
95% CI
Test Product
13.10
± 4.424
No Treatment
14.63
± 5.698
Change from pre-challenge after 3 Discs
Group
Value
95% CI
Test Product
4.58
± 3.261
No Treatment
6.45
± 4.531
Change from pre-challenge after 6 Discs
Group
Value
95% CI
Test Product
11.34
± 6.102
No Treatment
16.66
± 10.636
Change from pre-challenge after 9 Discs
Group
Value
95% CI
Test Product
20.68
± 12.242
No Treatment
27.26
± 15.987
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 29Secondary· 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.
Group
Value
95% CI
Test Product
173.16
± 44.816
No Treatment
213.89
± 29.648
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 29Secondary· 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.
Group
Value
95% CI
Test Product
84.70
± 23.413
No Treatment
107.75
± 20.999
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 FaceSecondary· At Baseline, Day 30, 31, 32, 33 and 34
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.
Day 30, Change from baseline, forearm
Group
Value
95% CI
Test Product
-0.37
± 2.351
No Treatment
1.12
± 2.348
Day 31, Change from baseline, forearm
Group
Value
95% CI
Test Product
-0.77
± 1.986
No Treatment
1.53
± 2.804
Day 32,Change from baseline, forearm
Group
Value
95% CI
Test Product
-0.17
± 2.322
No Treatment
1.48
± 2.110
Day 33,Change from baseline, forearm
Group
Value
95% CI
Test Product
-0.42
± 1.902
No Treatment
1.00
± 1.961
Day 34, Change from baseline, forearm
Group
Value
95% CI
Test Product
-0.59
± 1.889
No Treatment
1.18
± 1.927
Day 30, Change from baseline, face
Group
Value
95% CI
Test Product
-4.40
± 4.145
No Treatment
-3.18
± 3.873
Day 31, Change from baseline, face
Group
Value
95% CI
Test Product
-4.26
± 4.787
No Treatment
-3.27
± 4.112
Day 32, Change from baseline, face
Group
Value
95% CI
Test Product
-3.27
± 5.264
No Treatment
-3.05
± 4.672
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 FaceSecondary· At Day 30, 31, 32, 33, and 34
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.
Day 30, change from Day 29, forearm
Group
Value
95% CI
Test Product
0.20
± 1.970
No Treatment
0.25
± 1.696
Day 31, change from Day 29, forearm
Group
Value
95% CI
Test Product
-0.09
± 1.494
No Treatment
0.72
± 1.885
Day 32, change from Day 29, forearm
Group
Value
95% CI
Test Product
0.45
± 1.962
No Treatment
0.67
± 1.444
Day 33, change from Day 29, forearm
Group
Value
95% CI
Test Product
0.26
± 1.673
No Treatment
0.19
± 1.737
Day 34, change from Day 29, forearm
Group
Value
95% CI
Test Product
0.03
± 1.669
No Treatment
0.37
± 1.649
Day 30, change from Day 29, face
Group
Value
95% CI
Test Product
0.10
± 3.341
No Treatment
-0.05
± 2.000
Day 31, change from Day 29, face
Group
Value
95% CI
Test Product
0.22
± 3.807
No Treatment
0.01
± 2.833
Day 32, change from Day 29, face
Group
Value
95% CI
Test Product
1.17
± 4.399
No Treatment
0.22
± 2.941
Adverse events — posted to ClinicalTrials.gov
Time frame: Approximately 42 days..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this POC clinical study is to investigate the impact of the test product (Developmental Cosmetic Moisturising Cream) on skin barrier function and skin moisturisation on the forearm and face after 4 weeks of twice daily application compared to no treatment in participants with dry sensitive skin.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 18 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03216265.