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

GlaxoSmithKline1 site in 1 country69 target enrollmentFebruary 23, 2017

ConditionsSkin Care

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Care
Sponsor: GlaxoSmithKline
Enrollment: 69
Locations: 1
Primary Endpoint: Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated Versus (vs.) Untreated Sites on the Forearm
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

February 23, 2017

End Date

April 24, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.
•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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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(On Day 29)
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(At Day 30, 31, 32, 33, and 34)
Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated vs. Untreated Sites on the Face(At Baseline and Day 29)
Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites(At Baseline, Day 1 (30 minutes and 6 hours post study product application), Day 2, 15, and 29)
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Corneometry Over Treatment Period(Up to Day 29)
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(On Day 29 (including Pre-challenge))
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(Up to Day 34)
Change From Baseline in Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15(At Baseline, Day 2, and 15)
Standardised Area Under Curve (AUC1-29) of Change From Baseline in Transepidermal Water Loss (TEWL) Over Treatment Period(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(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(On Day 29)
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(Up to Day 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(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(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(At Day 29, 30, 31, 32, 33, and 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(Up to Day 34)
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(At Baseline, Day 30, 31, 32, 33 and 34)
Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29 of Positive Control Treated Site vs. Untreated Site on the Forearm.(At Baseline and Day 29)