Full Spectrum Hemp Observational Study

January 28, 2021 updated by: Charlotte's Web, Inc

Acne Vulgaris Blemish Full Spectrum Hemp Observational Study

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.

Study Overview

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

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Inclusive of genders, adolescents to elderly, ethnicities, and must present with facial blemishes.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Placebo (base cream without hemp)

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jeff Lokken, Charlottes Web, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (ACTUAL)

January 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Charlottes Web, Inc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The plan is to de-identify the subjects and present data in publication, and medical meetings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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