Full Spectrum Hemp Observational Study
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|ClinicalTrials.gov Identifier: NCT04730414|
Recruitment Status : Not yet recruiting
First Posted : January 29, 2021
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment|
|Acne Vulgaris Acne Vulgaris Superficial Mixed Comedonal and Inflammatory||Drug: Full-spectrum hemp (0.018% THC)|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||Acne Vulgaris Blemish Full Spectrum Hemp Observational Study|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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)
Other Name: Placebo (base cream without hemp)
- Facial Blemishes [ Time Frame: 2-3 months ]Total eradication of of acne vulgaris/blemishes with reduction of inflammation
- Improvement of overall skin tone [ Time Frame: 2-3-6 months ]Restoration of natural skin balance to provide secondary benefits for other skin maladies.
- Social Benefits of Full Spectrum Hemp [ Time Frame: 2-3-6 months ]Provide a significant quality of life in social settings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730414
|Contact: Sherry Bradford, PhDfirstname.lastname@example.org|
|Contact: Jeff Lokken, BS, MSemail@example.com|
|Study Director:||Jeff Lokken||Charlottes Web, Inc|