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

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.