Effect of an Emollient Cream Containing 0.5% Cannabidiol and 1% Hemp Oil in the Hydration and Erythema of the Skin
Condition: Cosmetics; Eczema
MeSH terms: Erythema
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Topical moisturizer
Intervention type(s): Other
Intervention description(s): The investigational product is an intensive emollient cream that is applied topically on the skin and is manufactured by Avicanna Inc. This preparation contains widely used ingredients from mineral and botanical origin aimed at soothing and conditioning the skin as well as improving hydration. The moisturizer also contains 1% hemp oil rich in essential fatty acids and antioxidants as well as 0.5% of CBD with regulatory and conditioning effect on the skin
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, open label, randomized study with passive control.
Masking: None (Open Label)
Primary purpose: Other
Keywords: CBD; Cosmetics; Dry skin