Overview

To Evaluate the Effect of Moisturizing Creams on Skin Barrier Function

Status:
Completed
Trial end date:
2019-04-16
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
GlaxoSmithKline
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.