- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04730414
Full Spectrum Hemp Observational Study
Acne Vulgaris Blemish Full Spectrum Hemp Observational Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sherry Bradford, PhD
- Phone Number: 7168607800
- Email: sherry.bradford.ctr@charlottesweb.com
Study Contact Backup
- Name: Jeff Lokken, BS, MS
- Phone Number: 2129339223
- Email: jeff.lokken@charlottesweb.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
Topical Application
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facial Blemishes
Time Frame: 2-3 months
|
Total eradication of of acne vulgaris/blemishes with reduction of inflammation
|
2-3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of overall skin tone
Time Frame: 2-3-6 months
|
Restoration of natural skin balance to provide secondary benefits for other skin maladies.
|
2-3-6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Benefits of Full Spectrum Hemp
Time Frame: 2-3-6 months
|
Provide a significant quality of life in social settings
|
2-3-6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jeff Lokken, Charlottes Web, Inc
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Charlottes Web, Inc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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