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Trial record 3 of 4 for:    topical, THC

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

Tracking Information
First Submitted Date January 26, 2021
First Posted Date January 29, 2021
Last Update Posted Date February 1, 2021
Estimated Study Start Date February 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2021)
Facial Blemishes [ Time Frame: 2-3 months ]
Total eradication of of acne vulgaris/blemishes with reduction of inflammation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 26, 2021)
Improvement of overall skin tone [ Time Frame: 2-3-6 months ]
Restoration of natural skin balance to provide secondary benefits for other skin maladies.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 26, 2021)
Social Benefits of Full Spectrum Hemp [ Time Frame: 2-3-6 months ]
Provide a significant quality of life in social settings
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Full Spectrum Hemp Observational Study
Official Title Acne Vulgaris Blemish Full Spectrum Hemp Observational Study
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.
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 [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Inclusive of genders, adolescents to elderly, ethnicities, and must present with facial blemishes.
Condition
  • Acne Vulgaris
  • Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
Intervention Drug: Full-spectrum hemp (0.018% THC)
Topical Application
Other Name: Placebo (base cream without hemp)
Study Groups/Cohorts 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.

Intervention: Drug: Full-spectrum hemp (0.018% THC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 26, 2021)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sherry Bradford, PhD 7168607800 sherry.bradford.ctr@charlottesweb.com
Contact: Jeff Lokken, BS, MS 2129339223 jeff.lokken@charlottesweb.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04730414
Other Study ID Numbers Charlottes Web, Inc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
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.
Responsible Party Charlotte's Web, Inc
Study Sponsor Charlotte's Web, Inc
Collaborators Not Provided
Investigators
Study Director: Jeff Lokken Charlottes Web, Inc
PRS Account Charlotte's Web, Inc
Verification Date January 2021