Full Spectrum Hemp Observational Study

NCT ID: NCT04730414

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2021-12-31

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.

Detailed Description

Charlotte's Web Full spectrum hemp blemish product will contain a mere 0.018% THC and will therefor not impart a psychotic affect. Hemp has been shown to be well tolerated in humans and has a very acceptable dosage, efficacy and safety profile when topically applied. The FDA has labeled hemp as Generally Regarded As Safe (GRAS) and as such reduces the risk of severe adverse reactions to the subject.

Benefits of hemp blemish 'cream" is that it has been formulated in such a way as to promote natural skin balance, and may eliminate skin dryness, inflammation, hyperpigmentation, and scaring.

The primary objective and endpoint of the study is to obtain total eradication of the blemish eruptions. The secondary objective and endpoints is the continued use of the hemp product will continue to prevent further blemish eruptions and provide other skin benefits especially reducing the propensity to scar.

Conditions

Acne Vulgaris; Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Full-spectrum hemp (0.018% THC)

Intervention Type: DRUG

Topical Application

Interventions

Full-spectrum hemp (0.018% THC)

Topical Application

Intervention Type: DRUG

Other Intervention Names

Placebo (base cream without hemp)

Eligibility Criteria

Inclusion Criteria

• Male/female
• Diagnosed acne vulgaris
• Not on current acne treatment(s) or off current treatment for 2 weeks
• 13-70 yrs old

Exclusion Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charlotte's Web, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Lokken

Role: STUDY_DIRECTOR

Charlottes Web, Inc

Central Contacts

Sherry Bradford, PhD

Role: CONTACT

sherry.bradford.ctr@charlottesweb.com

7168607800

Jeff Lokken, BS, MS

Role: CONTACT

jeff.lokken@charlottesweb.com

2129339223

Other Identifiers

Charlottes Web, Inc

Identifier Type: -

Identifier Source: org_study_id