Full Spectrum Hemp Observational Study

• Conditions: Acne Vulgaris; Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
• Interventions: Drug: Full-spectrum hemp (0.018% THC)

• Registration Number: NCT04730414
• Lead Sponsor: Charlotte's Web, Inc

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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-02
• Last Update Posted: 2021-02-01
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age, Male, Female, ethnicity,	Full-spectrum hemp (0.018% THC)	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.

Primary Outcome Measures

Name	Time	Method
Facial Blemishes	2-3 months	Total eradication of of acne vulgaris/blemishes with reduction of inflammation

Secondary Outcome Measures

Name	Time	Method
Improvement of overall skin tone	2-3-6 months	Restoration of natural skin balance to provide secondary benefits for other skin maladies.