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Trial record 1 of 3 for:    avicanna
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Effect of an Emollient Cream Containing 0.5% Cannabidiol and 1% Hemp Oil in the Hydration and Erythema of the Skin (Celosia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045314
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Avicanna Inc

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.

Condition or disease Intervention/treatment Phase
Cosmetics; Eczema Other: Topical moisturizer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
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
Official Title: Effect of an Emollient Cream Containing 0.5% Cannabidiol and 1% Hemp Oil in the Hydration and Erythema of the Skin
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Arm Intervention/treatment
Experimental: Before-and-after
54 Healthy adults 18 years of age or older at the visit or will receive the first application and will be evaluated according to the objectives defined in the study (short-term data) and to evaluate the long-term effects, two other visits will be made at intervals of 2 weeks to evaluate the impact of topical skin application according to the parameters defined in the study.
Other: Topical moisturizer
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




Primary Outcome Measures :
  1. Evaluate the effect on hydration of a single application of the topical preparation on facial skin [ Time Frame: 1 and 3 hours ]
    1. Evaluate the effect on hydration of a single application of the topical preparation on the skin of the volar forearm, through the direct measurement of its electrical properties as an indicator of water content at 1 and 3 hours

  2. Evaluate the effect on Hydration of periodic application of the topical preparation on facial skin [ Time Frame: 2 and 4 weeks ]
    2. Evaluate the effect on hydration of periodic application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 2 and 4 weeks.


Secondary Outcome Measures :
  1. Evaluate the short-term change in instrumentally assessed erythema [ Time Frame: Up to 3 hours ]
    Evaluate the short-term change in instrumentally assessed erythema (i.e., 1 and 3 hours), through the direct measurement of skin biochromophores at the face and the volar forearm.

  2. Evaluate the long-term change in instrumentally assessed erythema [ Time Frame: 4 weeks ]
    Evaluate the long-term change in instrumentally assessed erythema (i.e., 2 and 4 weeks), through the direct measurement of skin biochromophores at the face and the volar forearm.

  3. Evaluate the short-term effect of this topical preparation on the viscoelastic properties of the skin [ Time Frame: 3 hours ]
    Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the viscoelastic properties of the skin, through the direct measurement of its response to physical deformation by suction.

  4. Evaluate the long-term effect of this topical preparation on the viscoelastic properties of the skin [ Time Frame: 4 weeks ]
    Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the viscoelastic properties of the skin, through the direct measurement of its response to physical deformation by suction.

  5. Evaluate the short-term effect of this topical preparation on the skin functional properties [ Time Frame: 3 hours ]
    Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the skin functional properties, through the measurement of trans-epidermal water loss.

  6. Evaluate the long-term effect of this topical preparation on the skin functional properties [ Time Frame: 4 weeks ]
    Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the skin functional properties, through the measurement of trans-epidermal water loss.

  7. Evaluate the short and long-term appearance of evaluator assessed irritation [ Time Frame: 4 weeks ]

    Evaluate the short and long-term appearance of evaluator assessed irritation by visual scoring (i.e., 0 hours, 1 hours and 4 weeks).

    Perceived skinfeel attributes of creams and lotions (appearance, rub-in, absorption, appearance of skin, immediate and delayed after-feel) have been evaluated using a trained descriptive panel. In previously published studies researchers used the skinfeel spectrum descriptive analysis method to characterize skin care products. They used strict protocols for manipulation and precisely defined terms to describe the qualitative properties and their relative intensities in each product. The evaluation process was divided into four categories: pick-up (i.e., firmness, stickiness, cohesiveness, peaking); rub-out (i.e., wetness, spreadability, thickness, absorbency); residual feel; and appearance, immediate and after 20 minutes (i.e., glossy, sticky, slippery, oily, waxy, greasy)


  8. Evaluate the short and long-term emollient effect and acceptance [ Time Frame: 4 weeks ]

    Evaluate the short and long-term emollient effect and acceptance of this topical preparation, through the application of a perception survey (i.e., 0 hours, 1 hours and 4 weeks).

    Perceived skinfeel attributes of creams and lotions (appearance, rub-in, absorption, appearance of skin, immediate and delayed after-feel) have been evaluated using a trained descriptive panel. In previously published studies researchers used the skinfeel spectrum descriptive analysis method to characterize skin care products. They used strict protocols for manipulation and precisely defined terms to describe the qualitative properties and their relative intensities in each product. The evaluation process was divided into four categories: pick-up (i.e., firmness, stickiness, cohesiveness, peaking); rub-out (i.e., wetness, spreadability, thickness, absorbency); residual feel; and appearance, immediate and after 20 minutes (i.e., glossy, sticky, slippery, oily, waxy, greasy)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045314


Contacts
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Contact: Carlos E Maldonado, MD +573002548585 carlos.maldonado@avicanna.com
Contact: Amza Ali, MD 1.416.986.9167 amza.ali@avicanna.com

Sponsors and Collaborators
Avicanna Inc
Investigators
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Principal Investigator: Nicolas Medina, MD Caimed

Publications:

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Responsible Party: Avicanna Inc
ClinicalTrials.gov Identifier: NCT04045314    
Other Study ID Numbers: Av 0001 CeCol
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Avicanna Inc:
CBD
Cosmetics
Dry skin
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms
Epidiolex
Emollients
Anticonvulsants
Dermatologic Agents