Effect of an Emollient Cream Containing 0.5% Cannabidiol and 1% Hemp Oil in the Hydration and Erythema of the Skin

This research seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD and hemp oil on the skin of the volar forearm as well as the effect on instrumentally measured erythema. Study Design This is a prospective, open label, randomized study with passive control.

Healthy adults will be invited to participate and the general characteristics of the product will be explained, as well as the amount of time that will be required. The individuals that agree to participate will have to read and sign the informed consent, register contact information, and will be scheduled for visit 0 at the research center within 2 to 7 days. During this period, the subject will be told not to use abrasive cleansing products or topical medicines on the volar forearm, not to take more than one shower per day, and not to consume caffeine or alcohol 24 hours before attending the research center.

During the washout period the subject will receive a call to confirm compliance with washout requirements as well as visit 0 schedule. If washout conditions are not met, subject will be reminded to comply and visit will be re-scheduled within 2 to 7 days.

In visit 0 at the research center, contact information, demographic variables and standard anthropometric variables will be recorded. Subsequently, the subject will be given detailed information about the research product and protocol, accompanied by an information leaflet with indications regarding the use of the investigation product as well as recommendations on preferred hygiene regimens.

The subject will be able to review the material in a room under controlled ventilation, temperature, humidity and lighting conditions, where he or she will have to stay for a minimum of 30 minutes. After that, in an adjacent room under the same conditions, the basal characteristics of the skin at the volar forearm and the face will be measured. These are: capacitance, erythema, viscoelasticity and trans-epidermal water-loss (i.e., hour 0) for the volar forearm and erythema for the face. For the face, the bioengineering measurements will be made on at the center of the forehead and for the forearms the anterior surface of the forearms (i.e., volar forearm on both arms) will be used. On the forearms the area to perform measurements will be marked as a 5 by 3 cm rectangle centered at midpoint between the distal wrist crease and the anterior cubital fossa using a skin marker that with removable ink. Additionally, test sites should be uncovered and motionless for at least five minutes before measurement.