To Evaluate the Effect of Moisturizing Creams on Skin Barrier Function

NCT03804710 | Completed Results

• 1 other identifier: 209638
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Skin; Skin Care

Keywords

Skin care, Moisturizing Cream

Outcome Measures

Primary Outcomes (1)

• 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

  TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value.

  Baseline and Day 29

Secondary Outcomes (15)

• Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 29

  Baseline and Day 29

• Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15

  Baseline and Day 15

• Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15

  Baseline and Day 15

• 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

  Baseline, 30 mins and 6 hrs after first treatment application on Day 1 and 24 hrs after treatment application on Day 2

• 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

  Baseline, Day 1 and Day 2

Study Arms (3)

Test Product 1

EXPERIMENTAL

Participants will apply 2 pumps of the test product (approximately 0.3ml x 2= 0.6ml) to the randomly assigned side of the face, including forehead and chin, and 6 pumps of test product (approximately 0.3 ml x 6 = 1.8 ml) to the randomly assigned lower leg (below the knee; above the ankle) topically twice-daily (in the morning and evening) after cleansing.

Drug: Developmental moisturizing cream 1

Test Product 2

EXPERIMENTAL

Participants will apply pea-sized amount of the test product (approximately 0.6ml) to the randomly assigned side of the face, including forehead and chin, and walnut-sized amount of the test product (approximately 1.8 ml) to the randomly assigned lower leg (below the knee; above the ankle) twice-daily (in the morning and evening) after cleansing.

Drug: Developmental moisturizing cream 2

Standard soap cleanser

PLACEBO COMPARATOR

Participants will use wet soap with warm water and form lather. Participants will cleanse their entire face and both lower legs (between the knees and ankles) twice daily (morning and evening).

Other: Standard cleanser soap

Interventions

Developmental moisturizing cream 1 DRUG

Participants will topically apply developmental moisturizing cream 1

Test Product 1

Developmental moisturizing cream 2 DRUG

Participants will topically apply developmental moisturizing cream 2

Test Product 2

Standard cleanser soap OTHER

Participants will cleanse the entire face and both lower legs (between the knees and the ankles)with simple pure soap

Standard soap cleanser

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• 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.
• 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?
• 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.
• 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.
• A participant with a Fitzpatrick skin type I-IV.

You may not qualify if:

• 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.
• 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.
• 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.
• A female participant who is pregnant (self-reported) or intending to become pregnant.
• A female participant who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
• A participant with current or recent (within 6 months before the start of the study) history of atopic lesions and/or eczema.
• A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
• 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.
• A participant presenting open sores, pimples, or cysts at the application site (face or lower legs).
• A participant with an active dermatosis (local or disseminated) that might interfere with the results of the study.
• 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
• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: January 22, 2019
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-06

Locations

DE (1)