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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Skin Care

Treatments: Other: Test product (Moisturising cream); Other: No treatment; Other: Positive control (Commercial market place moisturising cream)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03216265

207451

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 3 patient groups

Test product/ No treatment

Other group

Description:

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

Treatment:

Other: No treatment

Other: Test product (Moisturising cream)

Test product/positive control

Other group

Description:

Participants randomized to this arm will apply Test and positive product at allocated sites.

Treatment:

Other: Positive control (Commercial market place moisturising cream)

Other: Test product (Moisturising cream)

Positive control /no treatment

Other group

Description:

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

Treatment:

Other: Positive control (Commercial market place moisturising cream)

Other: No treatment