Clinical trial NCT03804710: To Evaluate the Effect of Moisturizing Creams on Skin Barrier Function
Official title: A Clinical Study to Investigate the Effects of Two Developmental Cosmetic Moisturizing Cream Formulations on the Barrier Function of Human Skin on the Face and Legs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Skin
Skin Care
Keywords: Skin care, Moisturizing Cream
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 158
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: OTHER

Brief summary: The aim of this study is to evaluate the impact of twice-daily topical application of two different moisturizing creams on skin barrier function for 4 weeks.

Detailed description: This study will be a randomized, evaluator-blind, single-center, two-treatment regimen, controlled, parallel-group, with a treatment period of 4 weeks. The study will assess the skin barrier function of the two-treatment regimen in healthy participants with dry, sensitive skin on the face and lower legs. All participants will be centrally randomized to one of the 2 treatment groups using an Interactive Response Technology (IRT).

Eligibility criteria: Inclusion Criteria:

1. Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
2. A participant who is willing and able to comply with scheduled visits, the product application schedule, the Lifestyle Considerations, and other study procedures which includes: a) to remove facial make-up at the screening visit to allow visual assessments; b) using other skin-care products is not permitted including but not limited to: leave-on cosmetics, moisturizers, lotions, creams, sunscreens, soaps, cleansing, exfoliation products, etc. on their face or legs, other than the standard soap and study product(s) provided; c) at all post baseline study visit days, participants must cleanse their face and legs with the standard soap and then apply the test product (s) approximately 10-16 hours before each study appointment (i.e. evening before); d) no use of any product on the face or legs, including the standard soap and test product, within 10 hours of all instrumental measurements on visit days (no showering/bathing permitted with soaps/shampoo within this period) will be permitted.
3. A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee (if the investigator is not suitably qualified), no clinically significant/relevant abnormalities in medical history or upon dermatologist examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
4. A participant who responds "Yes" to the following question: Do you consider yourself to have dry, sensitive skin on your face and very dry skin on your legs?
5. A participant with an overall dryness assessment total score of ≥3 for each side of the face at screening visit (Visit 1) and baseline visit (Visit 2). With no more than 0.5-unit score difference between each side of the face. Including an examiner score of at ≥ 1 (slight) for the roughness parameter.
6. A participant with an overall dryness assessment total score of ≥6 for each leg at screening visit (Visit 1) and baseline visit (Visit 2). With no more than 1-unit score difference between each leg.
7. A participant with a Fitzpatrick skin type I-IV.

Exclusion Criteria:

1. A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
2. A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
3. A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product application or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
4. A female participant who is pregnant (self-reported) or intending to become pregnant.
5. A female participant who is breastfeeding.
6. A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
7. A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
8. A participant with current or recent (within 6 months before the start of the study) history of atopic lesions and/or eczema.
9. A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
10. A participant with any history of significant diseases or medical conditions known to alter skin or eye appearance or physiologic response (e.g. Type 2 diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
11. A participant presenting open sores, pimples, or cysts at the application site (face or lower legs).
12. A participant with an active dermatosis (local or disseminated) that might interfere with the results of the study.
13. A participant currently using any medication which in the opinion of the investigator, may affect the evaluation of the investigational product, or place the participant at undue risk
14. A participant who has used any of the following topical or systemic medications up to 1 month before the screening visit or intends to use during the study period: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS), and corticosteroids.
15. A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit or intends to use during the study period.
16. A participant who intends to use any topical drug or medication on the proposed application areas. A participant who has been vaccinated up to 1 month before the screening visit or is intending to receive a vaccination during their participation in the study.

18. A participant currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation 19. A participant with a recent history (within the last 5 years) of alcohol or other substance abuse.

20. A participant with any skin marks on the face or lower legs that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles). 21. Participants with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperemia or other active ocular diseases. 22. A participant who has previously been enrolled in this study. 23. A participant who is unwilling to abstain from smoking tobacco or using any other nicotine containing products.

24. A participant with visible sunburn on any of the test sites. 25. A participant with moles, tattoos, scars, hairs, etc. at the test areas if it is likely that they could affect the assessments. 26. A participant who has used self-tanning products on the test areas (face and arms) within 2 weeks prior to the screening visit. 27. A participant who intends to expose their skin to natural or artificial ultraviolet (UV) light (e.g.

sunbathing or tanning beds). 28. A participant with any participant self-assessed or dermatologist dryness parameter score 4 (very severe) on the test areas of the lower legs or face.

29. Any participant who, in the judgment of the Investigator, should not participate in the study.

Primary outcomes:
measure: Change From Baseline in Trans-epidermal Water Loss (TEWL) Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 29
timeFrame: Baseline and Day 29
Secondary outcomes:
measure: Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 29
timeFrame: Baseline and Day 29
measure: Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15
timeFrame: Baseline and Day 15
measure: Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15
timeFrame: Baseline and Day 15
measure: Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2
timeFrame: Baseline, 30 mins and 6 hrs after first treatment application on Day 1 and 24 hrs after treatment application on Day 2
measure: Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2
timeFrame: Baseline, Day 1 and Day 2
measure: Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29
timeFrame: Baseline, Day 15 and 29
measure: Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29
timeFrame: Baseline, Day 15 and Day 29
measure: Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34
timeFrame: Baseline, Day 30, 31, 32, 33 and 34
measure: Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34
timeFrame: Baseline, Day 30, 31, 32, 33 and 34
measure: Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34
timeFrame: Baseline, Day 30, 31, 32, 33 and 34
measure: Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34
timeFrame: Baseline, Day 30, 31, 32, 33 and 34
measure: Change From Pre-challenge in TEWL Following Application of Test Regimen on Face (Area 3 Compared to Area 4) at 3 Different Time Points of Strips Removal (3,6 and 9) at Day 29
timeFrame: Day 31
measure: Change From Pre-challenge in TEWL Following Application of Test Regimen on Legs (Area 7 Compared to Area 8) at 3 Different Time Points of Strips Removal (4, 8 and 12) at Day 29
timeFrame: Pre-challenge and Day 29
measure: Total Protein Content Extracted From D-Squame Discs From a Total of 9 Adhesive Discs on Face (Area 3 Compared to Area 4) at Day 29
timeFrame: Day 29
measure: Total Protein Content Extracted From D-Squame Discs From a Total of 12 Adhesive Discs on Leg (Area 7 Compared to Area 8) at Day 29
timeFrame: Day 29
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
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: