Cosmetic Acne Clinical Trial
Official title:
Effect of a Facial Cream Containing 0.5% Cannabidiol and 0.1% Hemp Oil on Skin Hydration and Characteristics Associated Acne-prone 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 facial skin as well as the effect on erythema, appearance, instrumentally measured sebum production and quality of life.
In this research effort, hypothesis is that application of the topical product improves skin
hydration as measured instrumentally by its electric properties as well as other variables
associated with skin hydration, sebum production and appearance. Therefore, this research
effort 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,
rosemary extract and hemp oil on facial skin. For this purpose, objective measures aimed at
stablishing the change of parameters related to skin water content will be measured.
Additionally, other measurements will be obtained to establish the change of different
parameters related to the effect on appearance, instrumentally measured sebum production and
quality of life. These include: instrumental and subjective measurement of oily skin and
standardized photography for assessment of imperfections as well as, a validated assessment
of the impact of acne-prone skin on quality of life.
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 (i.e., washout period), the subject will be told not to use abrasive
cleansing products or topical medicines on the facial skin, 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 investigational 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 facial skin will be measured through electrical and photometric
variables as well as self-assessment of oily skin, a standardized photograph with visual
assessment and self-image questionnaire (i.e., hour 0). The bioengineering measurements will
be made on the cheeks (i.e., between the base of the ear lobe and the apex of the chin) and
forehead (i.e., exact center of the forehead) and no marking of the measurement area will be
performed.
Once this process is done, the subject goes back to the waiting room, where a research
assistant explains how to apply the investigational product on the face and evaluate the
product characteristics. The subject applies the product and evaluates its characteristics.
10 minutes after application, the subject will complete a perception survey about the product
characteristics 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
electrical, photometric and colorimetric variables as well as self-assessment of oily skin
and a standardized photograph with visual assessment 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 electrical, photometric and colorimetric variables as well as
self-assessment of oily skin, a standardized photograph with visual assessment and self-image
questionnaire 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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04249128 -
Nourishing Hair, Skin & Nails Supplement Study (Derm Aid)
|
Phase 3 |