Full Spectrum Hemp Observational Study

Acne Vulgaris Clinical Trial

Official title:

Acne Vulgaris Blemish Full Spectrum Hemp Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04730414
• Other study ID #: Charlottes Web, Inc
• Status: Not yet recruiting
• Start date: February 2021
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Charlotte's Web, Inc
• Contact: Sherry Bradford, PhD
• Phone: 7168607800
• Email: sherry.bradford.ctr[@]charlottesweb.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Intervention

Drug:
• Full-spectrum hemp (0.018% THC)
Topical Application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charlotte's Web, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social Benefits of Full Spectrum Hemp	Provide a significant quality of life in social settings	2-3-6 months
Primary	Facial Blemishes	Total eradication of of acne vulgaris/blemishes with reduction of inflammation	2-3 months
Secondary	Improvement of overall skin tone	Restoration of natural skin balance to provide secondary benefits for other skin maladies.	2-3-6 months