Clinical trial NCT03216265: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-07-13
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).
* 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.

Primary outcomes:
measure: Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated Versus (vs.) Untreated Sites on the Forearm
timeFrame: At Baseline and Day 29
Secondary outcomes:
measure: Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated vs. Untreated Sites on the Face
timeFrame: At Baseline and Day 29
measure: Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites
timeFrame: At Baseline, Day 1 (30 minutes and 6 hours post study product application), Day 2, 15, and 29
measure: Change From Baseline in Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15
timeFrame: At Baseline, Day 2, and 15
measure: Standardised Area Under Curve (AUC1-29) of Change From Baseline in Corneometry Over Treatment Period
timeFrame: Up to Day 29
measure: Standardised Area Under Curve (AUC1-29) of Change From Baseline in Transepidermal Water Loss (TEWL) Over Treatment Period
timeFrame: Up to Day 29
measure: 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
timeFrame: On Day 29 (including Pre-challenge)
measure: 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
timeFrame: On Day 29 (including Pre-challenge)
measure: 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
timeFrame: On Day 29
measure: 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
timeFrame: On Day 29
measure: 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
timeFrame: At Baseline, Day 30, 31, 32, 33 and 34
measure: 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
timeFrame: At Day 30, 31, 32, 33, and 34
measure: 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
timeFrame: Up to Day 34
measure: 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
timeFrame: Up to Day 34
measure: 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
timeFrame: At Baseline, Day 30, 31, 32, 33, and 34
measure: 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
timeFrame: At Day 29, 30, 31, 32, 33, and 34
measure: 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
timeFrame: Up to Day 34
measure: 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
timeFrame: Up to Day 34
measure: Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29 of Positive Control Treated Site vs. Untreated Site on the Forearm.
timeFrame: At Baseline and Day 29
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.