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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acne Vulgaris Acne Vulgaris Superficial Mixed Comedonal and Inflammatory Drug: Full-spectrum hemp (0.018% THC)

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.

Drug: Full-spectrum hemp (0.018% THC)
Topical Application
Other Name: Placebo (base cream without hemp)




Primary Outcome Measures :
  1. Facial Blemishes [ Time Frame: 2-3 months ]
    Total eradication of of acne vulgaris/blemishes with reduction of inflammation


Secondary Outcome Measures :
  1. Improvement of overall skin tone [ Time Frame: 2-3-6 months ]
    Restoration of natural skin balance to provide secondary benefits for other skin maladies.


Other Outcome Measures:
  1. Social Benefits of Full Spectrum Hemp [ Time Frame: 2-3-6 months ]
    Provide a significant quality of life in social settings



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Inclusive of genders, adolescents to elderly, ethnicities, and must present with facial blemishes.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Sherry Bradford, PhD 7168607800 sherry.bradford.ctr@charlottesweb.com
Contact: Jeff Lokken, BS, MS 2129339223 jeff.lokken@charlottesweb.com

Sponsors and Collaborators
Charlotte's Web, Inc
Investigators
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Study Director: Jeff Lokken Charlottes Web, Inc
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Responsible Party: Charlotte's Web, Inc
ClinicalTrials.gov Identifier: NCT04730414    
Other Study ID Numbers: Charlottes Web, Inc
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The plan is to de-identify the subjects and present data in publication, and medical meetings.

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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
Keywords provided by Charlotte's Web, Inc:
Blemishes
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases