Cosmetics; Eczema Clinical Trial
Official title:
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.
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.
Once this process is done, the subject goes back to the waiting room, where a research
assistant randomizes the arm using the specially designed field on the platform and explains
to the subject how the product must be applied from that moment on (on the face and the
forearm). The subject will inspect the product before application and 10 minutes after
application will complete a perception survey about the product characteristics and sensation
produced on the skin. Afterwards, the subject may leave the room under controlled conditions;
however, he or she must return 30 minutes prior to the next measurements.
One hour after the application of the topical product (including 30 minutes of
acclimatization in the room under controlled conditions), a new measurement of the
capacitance, erythema, viscoelasticity and trans-epidermal water-loss is made. This procedure
is repeated after 3 hours (including 30 minutes of acclimatization in the room under
controlled conditions). Once the last measurement is made the subject completes the last part
of the survey and is given a vessel containing the investigational product and instructions
regarding its usage will be reinforced. Additionally, schedule for next visit will be
determined at this time.
The subject must apply the product according to the indications and keep a journal of the
applications. Additionally, the subject must refrain from using other topical products on the
volar forearm or systemic products that may alter the skin conditions. Furthermore, there
will be a follow-up call to remind the participant to comply with the requirements and
confirm schedule next visit.
Two weeks after visit 0, the subject will return to the research center, where a new
measurement of the capacitance, erythema, viscoelasticity and trans-epidermal water-loss is
made. This procedure is repeated by the 4th week, additionally, the subject will answer the
last part of the perception survey in this visit. Once this is completed the product
application phase will be terminated and the amount of remaining product as well as any
significant journal entries will be registered at this point.
Throughout the study there will be tolerance and safety monitoring in every visit and
follow-up call, as follows: Upon first application of the investigational product there will
be an observation of the subject during a 15-minute period done by the research staff, a
physician will be available to assess any possible allergic reaction or significant
irritation.
The research staff will examine the application site of the research product to find
potential local reactions and will ask about any systemic symptom. If no adverse reactions
occur, the information will be recorded. Similarly, if any adverse reaction, systemic
reaction or adverse event occurs it will be recorded and the physician will take the
necessary measures to ensure subject safety according to his expert judgement and initiate
event reporting according to applicable regulation. Finally, in every phone call made by the
call center, adherence and tolerance questions will be made and recorded.
At the 5th week, the subject will receive a final follow-up call to record any events that
might have appeared after removing the product, thus ending follow-up phase.
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