Effect of a Facial Cream Containing Cannabidiol and Hemp Oil on Skin Hydration and Acne-prone Skin
Condition: Cosmetic Acne
MeSH terms: Acne Vulgaris
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 facial skin as well as the effect on erythema, appearance, instrumentally
      measured sebum production and quality of life.
    

Detailed description: 
      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
    

Intervention name(s): Topical Moisturizer
Intervention type(s): Other
Intervention description(s): The investigational product is a moisturizing facial cream for skin with imperfections that is applied topically and is manufactured by Avicanna Inc. This preparation contains widely used ingredients from mineral and botanical origin aimed at improving skin hydration and characteristics associated acne-prone skin. The moisturizer also contains 0.1% of hemp oil rich in essential fatty acids and antioxidants and 0.5% of cannabidiol with regulatory effect on the skin.
Intervention model: Single Group Assignment
Intervention model description: This is a quasi-experimental (i.e., prospective, non-randomized, non-controlled), open label trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: CBD; Cosmetics; Acne-prone skin; Oily Skin