Full Spectrum Hemp Observational Study

NCT04730414 | Unknown DMC FDA Drug

• 1 other identifier: Charlottes Web, Inc
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

In westernized societies, acne vulgaris is nearly a universal skin disease afflicting 79% to 95% of the adolescent population; older than 25 years - 40% to 54% have facial blemishes and persists into middle age in 12% of women and 3% of men. Standard treatment modalities present with high risk morbidities. Charlotte's Web hemp blemish product is predicted to significantly reduce the risks mentioned above, while improving efficacy as well as imparting other skin benefits.

Conditions

Acne Vulgaris; Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Keywords

Blemishes

Outcome Measures

Primary Outcomes (1)

• Facial Blemishes

  Total eradication of of acne vulgaris/blemishes with reduction of inflammation

  2-3 months

Secondary Outcomes (1)

• Improvement of overall skin tone

  2-3-6 months

Other Outcomes (1)

• Social Benefits of Full Spectrum Hemp

  2-3-6 months

Study Arms (1)

Age, Male, Female, ethnicity,

The aim of the study is to be inclusive of all groups as to avoid bias. Furthermore, the study aims to determine if its formulation will encompass all skin types, genders and age groups. Full-spectrum hemp dosage is determined to begin with 40mg - 2-3X/day = topical application; for a period of 2-3 months. Drug: Full Spectrum hemp (0.018% THC), Topical Application Placebo = cream without hemp (Double blinded) One cream will be placed on one side of the face (R/L) and the other cream on the other side of the face.

Drug: Full-spectrum hemp (0.018% THC)

Interventions

Full-spectrum hemp (0.018% THC) DRUG

Topical Application

Also known as: Placebo (base cream without hemp)

Age, Male, Female, ethnicity,

Eligibility Criteria

• Age: 13 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inclusive of genders, adolescents to elderly, ethnicities, and must present with facial blemishes.

You may qualify if:

• Male/female
• Diagnosed acne vulgaris
• Not on current acne treatment(s) or off current treatment for 2 weeks
• yrs old

You may not qualify if:

• Not willing to stop current acne treatment(s)
• males that present with facial hair
• active TB, HIV or hepatitis
• pregnant or lactating females

Sponsors & Collaborators

• Charlotte's Web, Inc: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Jeff Lokken

  Charlottes Web, Inc

  STUDY DIRECTOR

Central Study Contacts

Sherry Bradford, PhD

CONTACT

7168607800; sherry.bradford.ctr@charlottesweb.com

Jeff Lokken, BS, MS

CONTACT

2129339223; jeff.lokken@charlottesweb.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: February 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share