Acne VulgarisNCT04730414
Full Spectrum Hemp Observational Study
An observational study of Acne Vulgaris and Acne Vulgaris Superficial Mixed Comedonal and Inflammatory, run by Charlotte's Web, Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Acne Vulgaris, Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
- What is being tested?
- Full-spectrum hemp (0.018% THC)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Dec 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inclusive of genders, adolescents to elderly, ethnicities, and must present with facial blemishes.
Who may be able to join
- Male/female
- Diagnosed acne vulgaris
- Not on current acne treatment(s) or off current treatment for 2 weeks
- 13-70 yrs old
Who cannot join
- Not willing to stop current acne treatment(s)
- males that present with facial hair
- active TB, HIV or hepatitis
- pregnant or lactating females
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Full-spectrum hemp (0.018% THC)
- Keywords
- Blemishes
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-spectrum hemp (0.018% THC)Drug
Also called Placebo (base cream without hemp)
Topical Application
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Full-spectrum hemp (0.018% THC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Blemishes
Total eradication of of acne vulgaris/blemishes with reduction of inflammation
Measured: 2-3 months
Secondary outcomes (1)
Improvement of overall skin tone
Restoration of natural skin balance to provide secondary benefits for other skin maladies.
Measured: 2-3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Charlotte's Web, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Lokken, Study director, Charlottes Web, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730414
- Sponsor's protocol ID
- Charlottes Web, Inc
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to de-identify the subjects and present data in publication, and medical meetings.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acne Vulgaris Blemish Full Spectrum Hemp Observational Study
- ClinicalTrials.gov ID
- NCT04730414
- Acronym / sponsor ID
- Charlottes Web, Inc
- Keywords
- Blemishes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charlotte's Web, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age, Male, Female, ethnicity, | – | Drug: Full-spectrum hemp (0.018% THC)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. |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusive of genders, adolescents to elderly, ethnicities, and must present with facial blemishes.
Key inclusion criteria (4 listed)
- Male/female
- Diagnosed acne vulgaris
- Not on current acne treatment(s) or off current treatment for 2 weeks
- 13-70 yrs old
Key exclusion criteria (4 listed)
- Not willing to stop current acne treatment(s)
- males that present with facial hair
- active TB, HIV or hepatitis
- pregnant or lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-spectrum hemp (0.018% THC)Also: Placebo (base cream without hemp)Topical Application | Drug | Age, Male, Female, ethnicity, |
Primary outcome
Facial Blemishes
Time frame: 2-3 months
Total eradication of of acne vulgaris/blemishes with reduction of inflammation
1 secondary outcome
Improvement of overall skin tone
Time frame: 2-3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No. The plan is to de-identify the subjects and present data in publication, and medical meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Lokken study director
Charlottes Web, Inc
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris and Acne Vulgaris Superficial Mixed Comedonal and Inflammatory, run by Charlotte's Web, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherry Bradford, PhD (7168607800, sherry.bradford.ctr@charlottesweb.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Blemishes (time frame: 2-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.