NCT03180645

Proof of Concept Anti-ageing Clinical Study in Healthy Subjects

Completed NA Results posted Last updated 1 July 2019

What this trial tests

NA trial testing Test product (Moisturising cream) in Skin Aging in 72 participants. Completed in 21 April 2017.

Timeline

20 March 2017

Primary endpoint
21 April 2017

21 April 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	72
Start date	20 March 2017
Primary completion	21 April 2017
Estimated completion	21 April 2017
Sites	1 location across Germany

Drugs / interventions tested

• Test product (Moisturising cream)
• Positive control (Commercial market place moisturising cream)
• No treatment — full drug profile →

Conditions studied

• Skin Aging — all drugs for Skin Aging →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 30 to 65, female only, with Skin Aging. 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 Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29 Primary · At Baseline and Day 29

Using fringe projection and optical triangulation techniques, the 3D (three dimensional) surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).

Group	Value	95% CI
Test Product	-1.90	± 4.245
No Treatment	-0.12	± 3.478

Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15 Secondary · At Baseline and Day 15

Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).

Group	Value	95% CI
Test Product	-0.65	± 4.487
No Treatment	-0.18	± 3.237

Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29 Secondary · At Baseline, Day 15 and 29

Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra is the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).

Day 15

Group	Value	95% CI
Positive Control	0.18	± 2.543
No Treatment	-0.18	± 3.237

Day 29

Group	Value	95% CI
Positive Control	-0.13	± 3.461
No Treatment	-0.12	± 3.478

Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29 Secondary · At Baseline, Day 15 and 29

Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Rz usually used for wrinkle assessments, representing the rough structure, such as wrinkles. Rz was an average of the 5 sub-profiles (peak to valley heights) local maximum. From each local profile the peak to peak height value is calculated; the average of the 5 peak to peak height values was Rz.

Day 15

Group	Value	95% CI
Test Product	-1.92	± 18.864
Positive Control	0.97	± 10.508
No Treatment	-1.46	± 13.194

Day 29

Group	Value	95% CI
Test Product	-7.01	± 18.395
Positive Control	-0.55	± 14.144
No Treatment	-1.08	± 15.279

Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29 Secondary · At Baseline, Day 15 and 29

Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Sa was the arithmetic average of the absolute (non- signed) heights of the topography points. Sa was the 3D Area -Equivalent of 2D profile roughness parameter Ra.

Day15

Group	Value	95% CI
Test Product	-0.60	± 4.426
Positive Control	0.17	± 2.646
No Treatment	-0.08	± 3.291

Day 29

Group	Value	95% CI
Test Product	-1.83	± 4.076
Positive Control	-0.21	± 3.354
No Treatment	-0.26	± 3.433

Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29 Secondary · At Baseline, Day 15 and 29

Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Stm was an average of the 5x5 sub-areas (peak to valley heights) local maximum: The surface was virtually divided into 25 sub-surfaces (5 rows, 5 columns); from each local surface the peak to pe

Day 15

Group	Value	95% CI
Test Product	5.81	± 62.571
Positive Control	5.35	± 29.232
No Treatment	-2.02	± 33.670

Day 29

Group	Value	95% CI
Test Product	-12.89	± 47.901
Positive Control	0.23	± 35.323
No Treatment	-3.27	± 35.025

Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29 Secondary · At Baseline, Day 15 and 29

A blinded, trained and qualified examiner performed Clinical Fitzpatrick Wrinkle Score assessments by visually grading the crow's feet area under standard conditions of illumination. Fitzpatrick Wrinkle Scores range between 1-9 where 1-3= Fine wrinkles, 4-6= Fine to moderate depth wrinkles, a moderate number of wrinkles, 7-9= Fine to deep wrinkles, numerous lines, with or without redundant skin folds. Low value indicated better results.

Day 15

Group	Value	95% CI
Test Product	-0.33	± 0.559
Positive Control	-0.28	± 0.544
No Treatment	-0.15	± 0.420

Day 29

Group	Value	95% CI
Test Product	-0.51	± 0.688
Positive Control	-0.58	± 0.583
No Treatment	-0.22	± 0.664

Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29 Secondary · At Baseline, Day 15 and 29

Measurement of Stratum Corneum (SC) hydration was performed by the electrical capacitance method with a Corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. An electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturisation was measured. Higher value of corneometery indicates high moisture content.

Day 15

Group	Value	95% CI
Test Product	6.12	± 7.566
Positive Control	7.13	± 8.238
No Treatment	-1.09	± 10.813

Day 29

Group	Value	95% CI
Test Product	8.30	± 8.865
Positive Control	10.03	± 10.070
No Treatment	1.62	± 10.186

Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29 Secondary · At Baseline and Day 29

High resolution images of the left and right side of each participant's whole half-face were taken at baseline and Day 29. Each blinded image pair was randomly displayed on a color-calibrated screen and assessed by a panel of lay graders, who ranked each image based on texture, defined as pores, smoothness and unevenness, on a scale of: 1 = better; or 2 = worse (lower score indicated improvement). The total proportion of improvement (from all lay graders) on Day 29 than baseline is reported for this endpoint.

Group	Value	95% CI
Test Product	41.49	38.60 – 44.43
Positive Control	39.54	36.61 – 42.52
Negative Control	40.58	37.67 – 43.54

Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29 Secondary · At Baseline, Day 15 and 29

The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) was displayed as curves (penetration depth in

Day 15

Group	Value	95% CI
Test Product	0.05	± 0.132
Positive Control	0.01	± 0.121
No Treatment	-0.05	± 0.104

Day 29

Group	Value	95% CI
Test Product	0.08	± 0.144
Positive Control	0.05	± 0.139
No Treatment	0.03	± 0.113

Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29 Secondary · At Baseline, Day 15 and 29

The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in

Day 15

Group	Value	95% CI
Test Product	0.02	± 0.079
Positive Control	0.01	± 0.075
No Treatment	-0.03	± 0.063

Day 29

Group	Value	95% CI
Test Product	0.03	± 0.093
Positive Control	0.02	± 0.079
No Treatment	0.02	± 0.067

Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29 Secondary · At Baseline, Day 15 and 29

TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors (temperature and relative humidity) placed at different distances perpendicularly to the skin. Measurements were taken in triplicate and then an average (mean) reading was calculated on the left and right Sub-ocular/ Cheek Area directly from the corner of the eyes onto the middle of the cheekbone. A decrease in TEWL corresponds to an improved skin barrier function.

Day 15

Group	Value	95% CI
Test Product	-4.17	± 4.904
Positive Control	-5.98	± 4.994
No Treatment	-2.02	± 4.713

Day 29

Group	Value	95% CI
Test Product	-5.18	± 3.719
Positive Control	-6.62	± 5.791
No Treatment	-3.00	± 4.564

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately 30 days. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Product

Serious: 0/48 (0%)

Deaths: 0/48

Positive Control

Serious: 0/48 (0%)

Deaths: 0/48

No Treatment

Serious: 0/48 (0%)

Deaths: 0/48

Overall Participants

Serious: 0/72 (0%)

Deaths: 0/72

Other adverse events (17 terms — click to expand)

Reaction	System	Test Product	Positive Control	No Treatment	Overall Participants
Headache	Nervous system disorders	—	—	—	—
BURNING SENSATION	Nervous system disorders	—	—	—	—
ERYTHEMA	Skin and subcutaneous tissue disorders	—	—	—	—
SKIN EXFOLIATION	Skin and subcutaneous tissue disorders	—	—	—	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—	—	—	—
DRY SKIN	Skin and subcutaneous tissue disorders	—	—	—	—
PRURITUS	Skin and subcutaneous tissue disorders	—	—	—	—
RASH PAPULAR	Skin and subcutaneous tissue disorders	—	—	—	—
SKIN TIGHTNESS	Skin and subcutaneous tissue disorders	—	—	—	—
NASOPHARYNGITIS	Infections and infestations	—	—	—	—
OTITIS MEDIA	Infections and infestations	—	—	—	—
ORAL HERPES	Infections and infestations	—	—	—	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—	—	—	—
DRY EYE	Eye disorders	—	—	—	—
SLEEP DISORDER	Psychiatric disorders	—	—	—	—
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	—	—	—	—
SCRATCH	Injury, poisoning and procedural complications	—	—	—	—

Data from ClinicalTrials.gov NCT03180645 adverse events section.

Sponsor's own description

The objective of this POC clinical study is to evaluate the moisturising effects on fine lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks of twice daily application of the test product on participants presenting visible signs of ageing.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cosmetic benefit of a biomimetic lamellar cream formulation on barrier function or the appearance of fine lines and wrinkles in randomized proof-of-concept clinical studies.
   Nisbet S, Mahalingam H, Gfeller CF, Biggs E, et al · · 2019 · cited 5× · PMID 30414275 · DOI 10.1111/ics.12499
2. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148