Clinical trial NCT04045314: Effect of an Emollient Cream Containing 0.5% Cannabidiol and 1% Hemp Oil in the Hydration and Erythema of the Skin
Official title: Effect of an Emollient Cream Containing 0.5% Cannabidiol and 1% Hemp Oil in the Hydration and Erythema of the Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cosmetics; Eczema
Keywords: CBD
Cosmetics
Dry skin
Lead sponsor: Avicanna Inc
Sponsor class: INDUSTRY
First posted: 2019-08-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, open label, randomized study with passive control.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult (i.e., over 18 years old) men or women.
* Dry skin (i.e., Modified Kligman test \>0)
* Accepts and signs the informed consent.

Exclusion Criteria

* Pregnant or breast-feeding women
* Subjects with a chronic disease that requires medication
* Subjects with known diagnosis of cancer
* Smoking habit or alcohol consumption habit (i.e., once a day or more)
* Recreational o medicinal cannabinoid use
* Skin diseases (i.e., diseases that require care of a dermatologist)
* Current medication uses such as: Immunomodulators, antibiotics, corticoids or retinoids
* Hypersensitivity to any component of the research product
* Involvement in other clinical or cosmetic studies in the last 6 months
* Recent exposure to sun causing sun tanning (i.e., as reported by the subject causing discomfort or change in the usual appearance of the skin)
* Permanent decoration of the skin in the test area

Primary outcomes:
measure: Evaluate the effect on hydration of a single application of the topical preparation on facial skin
timeFrame: 1 and 3 hours
measure: Evaluate the effect on Hydration of periodic application of the topical preparation on facial skin
timeFrame: 2 and 4 weeks
Secondary outcomes:
measure: Evaluate the short-term change in instrumentally assessed erythema
timeFrame: Up to 3 hours
measure: Evaluate the long-term change in instrumentally assessed erythema
timeFrame: 4 weeks
measure: Evaluate the short-term effect of this topical preparation on the viscoelastic properties of the skin
timeFrame: 3 hours
measure: Evaluate the long-term effect of this topical preparation on the viscoelastic properties of the skin
timeFrame: 4 weeks
measure: Evaluate the short-term effect of this topical preparation on the skin functional properties
timeFrame: 3 hours
measure: Evaluate the long-term effect of this topical preparation on the skin functional properties
timeFrame: 4 weeks
measure: Evaluate the short and long-term appearance of evaluator assessed irritation
timeFrame: 4 weeks
measure: Evaluate the short and long-term emollient effect and acceptance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chia
country: Colombia
facility: VITA
state: Cundinamarca
Study officials:
affiliation: Centro de Atencion e Investigacion Medica
name: Maria A Granados, MD., MSc.
role: PRINCIPAL_INVESTIGATOR
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