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

NCT04045119 | Completed

• 1 other identifier: Av 0002 DaCol
• Study Type: interventional
• Target: 54
• 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 facial skin as well as the effect on erythema, appearance, instrumentally measured sebum production and quality of life.

Conditions

Cosmetic Acne

Keywords

CBD; Cosmetics; Acne-prone skin; Oily Skin

Outcome Measures

Primary Outcomes (2)

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

  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.

  Change from baseline at 1 and 3 hours

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

  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.

  Change from baseline at 2 and 4 weeks

Secondary Outcomes (11)

• Evaluate the short-term change in instrumentally assessed measurement of oily skin

  Change from baseline at 1 and 3 hours

• Evaluate the long-term change in instrumentally assessed measurement of oily skin

  Change from baseline at 2 and 4 weeks

• Evaluate the short-term change in instrumentally measured skin biochromophores

  Change from baseline at 1 and 3 hours

• Evaluate the long-term change in instrumentally measured skin biochromophores

  Change from baseline at 2 and 4 weeks

• Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on subjective assessment of oily skin

  Change from baseline at 1 and 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 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

Interventions

Topical Moisturizer OTHER

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.

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.
• Oily or acne-prone skin as defined by self-assessment
• 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 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

Sponsors & Collaborators

• Avicanna Inc: lead

Study Sites (1)

VITA

Chía, Cundinamarca, 00000, Colombia

Location

Related Publications (18)

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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 quasi-experimental (i.e., prospective, non-randomized, non-controlled), open label trial

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: October 1, 2019
• Primary Completion: January 2, 2020
• Study Completion: January 2, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)