Effect of an Emollient Cream Containing 0.5% Cannabidiol and 1% Hemp Oil in the Hydration and Erythema of the Skin

NCT04045314 | Completed

• 1 other identifier: Av 0001 CeCol
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Cosmetics; Eczema

Keywords

CBD; Cosmetics; Dry skin

Outcome Measures

Primary Outcomes (2)

• Evaluate the effect on hydration of a single application of the topical preparation on facial skin

  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

  1 and 3 hours

• Evaluate the effect on Hydration of periodic application of the topical preparation on facial skin

  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.

  2 and 4 weeks

Secondary Outcomes (8)

• Evaluate the short-term change in instrumentally assessed erythema

  Up to 3 hours

• Evaluate the long-term change in instrumentally assessed erythema

  4 weeks

• Evaluate the short-term effect of this topical preparation on the viscoelastic properties of the skin

  3 hours

• Evaluate the long-term effect of this topical preparation on the viscoelastic properties of the skin

  4 weeks

• Evaluate the short-term effect of this topical preparation on the skin functional properties

  3 hours

Study Arms (1)

Before-and-after

EXPERIMENTAL

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

Interventions

Topical moisturizer OTHER

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

Before-and-after

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avicanna Inc: lead

Study Sites (1)

VITA

Chía, Cundinamarca, 00000, Colombia

Location

Related Publications (22)

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MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Maria A Granados, MD., MSc.

  Centro de Atencion e Investigacion Medica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, open label, randomized study with passive control.

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: August 5, 2019
• Study Start: August 15, 2019
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)