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Effect of a Facial Cream Containing Cannabidiol and Hemp Oil on Skin Hydration and Acne-prone Skin (Dahlia)

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ClinicalTrials.gov Identifier: NCT04045119
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : September 20, 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 facial skin as well as the effect on erythema, appearance, instrumentally measured sebum production and quality of life.

Condition or disease Intervention/treatment Phase
Cosmetic Acne Other: Topical Moisturizer Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
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
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
Estimated Study Start Date : September 23, 2019
Estimated Primary Completion Date : November 23, 2019
Estimated Study Completion Date : December 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne 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 longterm 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 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.




Primary Outcome Measures :
  1. Evaluate the effect on hydration of a single application of the topical preparation on facial skin [ Time Frame: Change from baseline at 1 and 3 hours ]
    Evaluate the effect on hydration of a single application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 1 and 3 hours. Measurement of the water content of the stratum corneum by capacitance.

  2. Evaluate the effect on hydration of periodic application of the topical preparation on facial skin [ Time Frame: Change from baseline at 2 and 4 weeks ]
    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. Measurement of the water content of the stratum corneum by capacitance.


Secondary Outcome Measures :
  1. Evaluate the short-term change in instrumentally assessed measurement of oily skin [ Time Frame: Change from baseline at 1 and 3 hours ]
    Evaluate the short-term change in instrumentally assessed measurement of oily skin (i.e., 1 and 3 hours), through photometrical transparency change of a translucent plastic strip.

  2. Evaluate the long-term change in instrumentally assessed measurement of oily skin [ Time Frame: Change from baseline at 2 and 4 weeks ]
    Evaluate the long-term change in instrumentally assessed measurement of oily skin (i.e., 2 and 4 weeks), through photometrical transparency change of a translucent plastic strip.

  3. Evaluate the short-term change in instrumentally measured skin biochromophores [ Time Frame: Change from baseline at 1 and 3 hours ]
    Evaluate the short-term change in instrumentally measured skin biochromophores (i.e., 1 and 3 hours)

  4. Evaluate the long-term change in instrumentally measured skin biochromophores [ Time Frame: Change from baseline at 2 and 4 weeks ]
    Evaluate the long-term change in instrumentally measured skin biochromophores (i.e., 2 and 4 weeks)

  5. Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on subjective assessment of oily skin [ Time Frame: Change from baseline at 1 and 3 hours ]
    Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on subjective assessment of oily skin, through the application of a validated questionnaire. Subjects will evaluate the degree of oiliness in a visual analog scale of 0 to 10 (i.e., 0: normal skin; 10: very severe oiliness)

  6. Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on subjective assessment of oily skin [ Time Frame: Change from baseline at 2 and 4 weeks ]
    Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on subjective assessment of oily skin, through the application of a validated questionnaire Subjects will evaluate the degree of oiliness in a visual analog scale of 0 to 10 (i.e., 0: normal skin; 10: very severe oiliness)

  7. Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the skin appearance [ Time Frame: Change from baseline at 1 and 3 hours ]
    Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the skin appearance, trough standardized photography and investigator evaluation. Subjects will be assessed by the investigation staff in comparison with baseline as follows: Almost clear if 90-99% clearance is observed Marked improvement if 75-89% clearance is observed Moderate improvement if 50-74% clearance is observed Minimal improvement if 25-49% clearance is observed No change if 0-24% clearance from baseline is observed

  8. Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the skin appearance [ Time Frame: Change from baseline at 2 and 4 weeks ]
    Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the skin appearance, trough standardized photography and investigator evaluation. Subjects will be assessed by the investigation staff in comparison with baseline as follows: Almost clear if 90-99% clearance is observed Marked improvement if 75-89% clearance is observed Moderate improvement if 50-74% clearance is observed Minimal improvement if 25-49% clearance is observed No change if 0-24% clearance from baseline is observed

  9. Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on quality of life [ Time Frame: Change from baseline at 2 and 4 weeks ]
    Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on quality of life, through the application of a standardized self-image questionnaire. The OSSIQ questionnaire will be used to perform self-image assessment by the subject using a five-point scale (never 0, rarely 1, sometimes 2, often 3, and always 4) to score 18 questions.

  10. Evaluate the short and long-term emollient effect and acceptance of this topical preparation [ Time Frame: 0 hours, 1 hour, and 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

  11. Evaluate the short and long-term tolerance of this topical preparation [ Time Frame: 0 hours, 1 hour, and 4 weeks ]
    Evaluate the short and long-term tolerance of this topical preparation, through the application of a perception survey. This is scored by investigators using a four-point scale: absent, mild, moderate and severe.



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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

Eligibility criteria Healthy adult men and women with oily skin from the municipality of Chia and neighboring communities.

Inclusion criteria:

  • Adult (i.e., over 18 years old) men or women.
  • Oily or acne-prone skin as defined by self-assessment
  • 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 or medicinal use of cannabinoids
  • 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): NCT04045119


Contacts
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Contact: Carlos E Maldonado, MD +573002548585 carlos.maldonado@avicanna.com
Contact: Amza Ali, MD +14169869167 amza.ali@avicanna.com

Sponsors and Collaborators
Avicanna Inc
Investigators
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Principal Investigator: Nicolás Medina-Silva, MD., MSc. Caimed

Publications:

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Responsible Party: Avicanna Inc
ClinicalTrials.gov Identifier: NCT04045119     History of Changes
Other Study ID Numbers: Av 0002 DaCol
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 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
Acne-prone skin
Oily Skin
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Epidiolex
Anticonvulsants