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

NCT03216265 | Completed Results

• 1 other identifier: 207451
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Care

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

• 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 Corneometry Over Treatment Period

  Up to Day 29

• Standardised Area Under Curve (AUC1-29) of Change From Baseline in Transepidermal Water Loss (TEWL) Over Treatment Period

  Up to Day 29

Study Arms (3)

Test product/ No treatment

OTHER

Participants randomized to this arm will apply Test product at allocated sites and leave other sites untreated.

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.

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.

Other: Positive control (Commercial market place moisturising cream); Other: No treatment

Interventions

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).

Test product/ No treatment; Test product/positive control

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).

Positive control /no treatment; Test product/positive control

No treatment OTHER

No treatment.

Positive control /no treatment; Test product/ No treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

Related Publications (1)

• 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.

  PMID: 30414275 DERIVED

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 13, 2017
• Study Start: February 23, 2017
• Primary Completion: April 19, 2017
• Study Completion: April 24, 2017
• Last Updated: April 18, 2019
• Results First Posted: April 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)