Skin CareNCT03216265
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
A study testing Test product (Moisturising cream) and No treatment in people with Skin Care, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Test product (Moisturising cream) and No treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteGermany
- Study dates
- 23 Feb 2017to 24 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- Self-reported dry, sensitive skin on the face and body.
- Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits.
- Trained examiner visual grading assessment score (including subject self-assessment of tightness) of overall dryness ≥ 3 with a score of at least 1 in the roughness parameter and 4 (for any individual parameter) on each of the forearms and each side of the face at the Screening visit (Visit 1) and Baseline visit (Visit 2).
- In addition, there will be no greater than 0.5 point difference between trained examiner visual grading scores of each volar forearm and each side of the face at the Screening and Baseline visits.
- Fitzpatrick skin type I-IV
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluations.
- Presence of open sores, pimples, or cysts at the application site.
- Active dermatosis (local or disseminated) that might interfere with the results of the study.
- Considered immune compromised.
Show all 26Show fewer
- Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
- Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit.
- Intention of using any oral or topical steroids.
- Regular use of inhaled steroids (occasional use is permitted).
- Regular use of topical anti-itch medications (occasional use permitted; the product should be applied with an applicator but not to the proposed application areas.
- Use of any topical drug or medication in the proposed application areas.
- Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit.
- Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation.
- Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication.
- Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last 5 years) of alcohol or other substance abuse.
- Smoker (including e-cigarettes)
- Moles, tattoos, scars, hairs, etc. at the test areas if it is likely that they could affect the assessments.
- Subject has visible sunburn on the test sites.
- Use of self-tanning products on the test areas (face and arms) within 2 weeks prior to the screening visit.
- Any individual parameter score 4 on any test areas of the face or either of the forearms as assessed by a trained examiner.
- Any Subject who, in the judgment of the Investigator, should not participate in the study.
- An employee of the sponsor or the study site or members of their immediate family.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept (POC) Clinical Study to Investigate the Effects of a Developmental Cosmetic Moisturising Cream on the Barrier Function of Human Skin on the Face and Forearm
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.
Read the detailed description
Areas on the volar forearm and each side of the face, will be selected for measurements of transepidermal water loss (TEWL) and corneometry to be conducted . A physical challenge and a regression period of 5 days is also included to evaluate skin barrier function and moisturisation.
A regression period of 5 days (Days 30, 31, 32, 33 and 34) of no study product use following the 4 week treatment phase is also included to evaluate skin barrier function and moisturisation.
- Conditions
- Skin Care
- Being tested
- Test product (Moisturising cream), Positive control (Commercial market place moisturising cream), No treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product (Moisturising cream)Other
Participants will be instructed to apply their assigned product to the randomly assigned sites twice daily (in the morning and evening).
Positive control (Commercial market place moisturising cream)Other
Participants will be instructed to apply their assigned product to the randomly assigned sites twice daily (in the morning and evening).
No treatmentOther
No treatment.
| Study group | Role | What they receive |
|---|---|---|
| Test product/ No treatment | Other | Participants randomized to this arm will apply Test product at allocated sites and leave other sites untreated. Receives: Other: Test product (Moisturising cream); Other: No treatment |
| Test product/positive control | Other | Participants randomized to this arm will apply Test and positive product at allocated sites. Receives: Other: Test product (Moisturising cream); Other: Positive control (Commercial market place moisturising cream) |
| Positive control /no treatment | Other | Participants randomized to this arm will apply Positive product at allocated sites and leave other sites untreated. Receives: Other: Positive control (Commercial market place moisturising cream); Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Baseline and Day 29
Secondary outcomes (18)
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.
Measured: At Baseline and Day 29
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.
Measured: At Baseline, Day 1 (30 minutes and 6 hours post study product application), Day 2, 15, and 29
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.
Measured: At Baseline, Day 2, and 15
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.
Measured: Up to Day 29
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.
Measured: Up to Day 29
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.
Measured: On Day 29 (including Pre-challenge)
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.
Measured: On Day 29 (including Pre-challenge)
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.
Measured: On Day 29
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.
Measured: On Day 29
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.
Measured: At Baseline, Day 30, 31, 32, 33 and 34
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.
Measured: At Day 30, 31, 32, 33, and 34
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.
Measured: Up to Day 34
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.
Measured: Up to Day 34
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.
Measured: At Baseline, Day 30, 31, 32, 33, and 34
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.
Measured: At Day 29, 30, 31, 32, 33, and 34
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.
Measured: Up to Day 34
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.
Measured: Up to Day 34
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.
Measured: At Baseline and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start23 Feb 2017
- Primary completion19 Apr 2017
- Study completion24 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin CareStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216265
- Sponsor's protocol ID
- 207451
- Status last verified
- Mar 2019
- First submitted
- 11 Jul 2017
- Last updated
- 18 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nisbet S, Mahalingam H, Gfeller CF, Biggs E, Lucas S, Thompson M, Cargill MR, Moore D, Bielfeldt S. 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. Int J Cosmet Sci. 2019 Feb;41(1):1-11. doi: 10.1111/ics.12499. Epub 2019 Feb 22.
PubMed 30414275
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept (POC) Clinical Study to Investigate the Effects of a Developmental Cosmetic Moisturising Cream on the Barrier Function of Human Skin on the Face and Forearm
- ClinicalTrials.gov ID
- NCT03216265
- Acronym / sponsor ID
- 207451
- Conditions
- Skin Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Posted 18 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Areas on the volar forearm and each side of the face, will be selected for measurements of transepidermal water loss (TEWL) and corneometry to be conducted . A physical challenge and a regression period of 5 days is also included to evaluate skin barrier function and moisturisation.
A regression period of 5 days (Days 30, 31, 32, 33 and 34) of no study product use following the 4 week treatment phase is also included to evaluate skin barrier function and moisturisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product/ No treatment | Other | Other: Test product (Moisturising cream), Other: No treatmentParticipants randomized to this arm will apply Test product at allocated sites and leave other sites untreated. |
| Test product/positive control | Other | Other: Test product (Moisturising cream), Other: Positive control (Commercial market place moisturising cream)Participants randomized to this arm will apply Test and positive product at allocated sites. |
| Positive control /no treatment | Other | Other: Positive control (Commercial market place moisturising cream), Other: No treatmentParticipants randomized to this arm will apply Positive product at allocated sites and leave other sites untreated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- Self-reported dry, sensitive skin on the face and body.
- Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits.
- Trained examiner visual grading assessment score (including subject self-assessment of tightness) of overall dryness ≥ 3 with a score of at least 1 in the roughness parameter and 4 (for any individual parameter) on each of the forearms and each side of the face at the Screening visit (Visit 1) and Baseline visit (Visit 2).
Key exclusion criteria (26 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluations.
- Presence of open sores, pimples, or cysts at the application site.
- Active dermatosis (local or disseminated) that might interfere with the results of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test product (Moisturising cream)Participants will be instructed to apply their assigned product to the randomly assigned sites twice daily (in the morning and evening). | Other | Test product/ No treatment, Test product/positive control |
| Positive control (Commercial market place moisturising cream)Participants will be instructed to apply their assigned product to the randomly assigned sites twice daily (in the morning and evening). | Other | Positive control /no treatment, Test product/positive control |
| No treatmentNo treatment. | Other | Positive control /no treatment, Test product/ No treatment |
Primary outcome
Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated Versus (vs.) Untreated Sites on the Forearm
Time frame: 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.
18 secondary outcomes
Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated vs. Untreated Sites on the Face
Time frame: At Baseline and Day 29
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites
Time frame: At Baseline, Day 1 (30 minutes and 6 hours post study product application), Day 2, 15, and 29
Change From Baseline in Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15
Time frame: At Baseline, Day 2, and 15
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Corneometry Over Treatment Period
Time frame: Up to Day 29
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Transepidermal Water Loss (TEWL) Over Treatment Period
Time frame: Up to Day 29
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
Time frame: On Day 29 (including Pre-challenge)
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
Time frame: On Day 29 (including Pre-challenge)
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
Time frame: On Day 29
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
Time frame: On Day 29
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
Time frame: At Baseline, Day 30, 31, 32, 33 and 34
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
Time frame: At Day 30, 31, 32, 33, and 34
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
Time frame: Up to Day 34
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
Time frame: Up to Day 34
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
Time frame: At Baseline, Day 30, 31, 32, 33, and 34
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
Time frame: At Day 29, 30, 31, 32, 33, and 34
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
Time frame: Up to Day 34
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
Time frame: Up to Day 34
Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29 of Positive Control Treated Site vs. Untreated Site on the Forearm.
Time frame: At Baseline and Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30414275Nisbet S, Mahalingam H, Gfeller CF, Biggs E, Lucas S, Thompson M, Cargill MR, Moore D, Bielfeldt S. 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. Int J Cosmet Sci. 2019 Feb;41(1):1-11. doi: 10.1111/ics.12499. Epub 2019 Feb 22.
- Individual participant dataSharing planned: No
Related trials for Skin Care
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Enrolling by invitationPhase 2
Deployment and Evaluation of Humanoid Robotics in Coalition-Aligned Clinical Care Settings
Mobility Impairment, Clinical Workflow Optimization
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
RecruitingPhase 2
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
Breast Cancer, Breast Cancer Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product (Moisturising cream) and No treatment in people with Skin Care, run by GlaxoSmithKline at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated Versus (vs.) Untreated Sites on the Forearm (time frame: At Baseline and Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03216265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.