Microneedling with CBD for Acne

Overseen By LaRyel Waldon, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rejuva Medical Aesthetics

Must not be taking: Accutane, Benzoyl peroxide

Disqualifiers: Uncontrolled disease, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of combining microneedling with CBD oil to treat moderate to severe acne. Participants will receive the treatment and undergo monitoring for side effects and improvements in their acne. It suits adults with moderate to severe facial acne who do not plan to change their skincare routine during the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using certain acne treatments like Accutane, benzoyl peroxide, azelaic acid, salicylic acid, and hydroquinone before joining. If you're using these, you'll need to stop 30 days before starting the study.

What prior data suggests that microneedling with CBD is safe for treating acne?

Research has shown that microneedling, combined with CBD (a compound from cannabis), is generally safe for treating various skin conditions. Studies indicate that microneedling is usually well-tolerated, with common side effects like mild skin irritation or redness, which are temporary.

When CBD is added, early findings suggest it does not cause major safety concerns. Although specific data on its long-term effects in this treatment is not yet available, CBD is already approved for some medical uses, suggesting it is reasonably safe.

Since this trial is in its early stages, the main goal is to ensure the treatment's safety for participants. Prospective participants should know that researchers will closely monitor patient responses to the treatment, watching for any harmful effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acne?

Unlike the standard acne treatments like topical retinoids, antibiotics, or benzoyl peroxide, microneedling with CBD offers a novel approach by combining a minimally invasive technique with the calming and anti-inflammatory properties of CBD oil. Most traditional treatments target bacteria or oil production, but this method stimulates skin regeneration while potentially reducing inflammation through CBD's unique properties. Researchers are excited about this treatment because it promises not only to improve acne symptoms but also to enhance skin texture and healing with fewer side effects.

What evidence suggests that microneedling with CBD might be an effective treatment for acne?

Research has shown that microneedling with CBD might help treat acne. In one study, microneedling effectively reduced acne spots without causing problems afterward. Another study found that most participants saw their acne improve by 50% or more. This trial will evaluate microneedling with CBD oil, which may work because microneedling helps the skin heal, and CBD reduces inflammation and bacteria that cause acne. Overall, early research suggests noticeable improvements in acne with microneedling and CBD. ^{1 3 6 7 8}

Who Is on the Research Team?

Kian Karimi, MD

Principal Investigator

Rejuva Medical Aesthetics

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with moderate to severe facial acne. Specific eligibility criteria are not provided, but typically participants must be in good health and not have conditions that could interfere with the study.

Inclusion Criteria

I will not undergo cosmetic or surgical procedures in the study area while participating.

My acne is moderate to very severe.

I will not start new skincare or medical treatments during the study.

Exclusion Criteria

Employees of the Investigator or research center or their immediate family members

I am able to follow the study's requirements without issues.

I am not sunburned and will avoid sun exposure during the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive microneedling with CBD oil at baseline, day 21, and day 42, with safety assessments and photography at each visit

9 weeks

3 in-person visits, 3 phone call visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with final assessments and photography on day 63

4 weeks

1 in-person visit

What Are the Treatments Tested in This Trial?

Interventions

• Microneedling with CBD

Trial Overview The study is testing microneedling combined with CBD and hempseed oil to see if it's safe and effective for treating moderate to severe acne. It's an open-label study, meaning both researchers and participants know what treatment is being given.

How Is the Trial Designed?

Group I: Microneedling with CBD oil Experimental Treatment 1 Intervention

All subjects will receive microneedling with CBD oil.At the baseline visit, the subject will undergo treatment by the principal investigator or subinvestigator. 3 days from the treatment visit, a phone call visit will be placed to assess any safety events and adherence to protocol guidelines. Day 21 visit, several assessments will be recorded and if no adverse events are reported related to the study device and/or procedure, a second treatment will be performed. After 3 days from the treatment visit, a phone call will be placed to assess any safety events. Subjects will have subjective assessments and photographs taken at all visits. At day 42, the subject will return for a third treatment if no adverse events related to the study device and/or procedure are reported. After 3 days from the treatment visit, a phone call will be placed to assess any safety events. On day 63,no treatment to be performed, only a safety assessment, standardized assessments/questionnaires and photography.

Who Is Running the Clinical Trial?

Rejuva Medical Aesthetics

Lead Sponsor

Trials

3

Recruited

40+

HealMD, LLC

Industry Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Microneedling is an effective treatment for various skin conditions, particularly acne scars and cosmetic rejuvenation, and has shown benefits for other issues like burn scars and alopecia, with mild and self-limited side effects.

The procedure is considered safe and cost-effective for all skin types, although more rigorous studies are needed to confirm its efficacy across different conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microneedling in All Skin Types: A Review. Bonati, LM., Epstein, GK., Strugar, TL.[2017]

Microneedling therapy is an effective treatment for atrophic acne scars, showing noticeable clinical improvement in patients after six sessions over three months, as evaluated through patient assessments and histological changes.

The treatment significantly increased collagen types I, III, and VII, as well as newly synthesized collagen, while reducing total elastin, indicating a positive remodeling effect on the skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microneedling Therapy for Atrophic Acne Scars: An Objective Evaluation. El-Domyati, M., Barakat, M., Awad, S., et al.[2022]

Microneedles (MNs) have gained popularity in cosmetics, but their safety profile is still being established as the FDA begins to regulate these devices.

Current literature indicates that while MNs are widely used, there is a need for more research to fully understand potential adverse effects, such as infections and skin reactions, associated with their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermatotoxicology of microneedles (MNs) in man. Cary, JH., Li, BS., Maibach, HI.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10549865/

Study to determine the safety and efficacy of microneedling ... In this pilot, microneedling did not cause post‐treatment complications and was seen to reduce acne lesions effectively.

2. withpower.com withpower.com/trial/phase-1-acne-vulgaris-4-2024-7cd30

Microneedling with CBD for Acne · Info for Participants Microneedling therapy is an effective treatment for atrophic acne scars, showing noticeable clinical improvement in patients after six sessions over three ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11511700/

The Potential Role of Cannabidiol in Cosmetic Dermatology NCT06362889 is a phase I study to evaluate the safety and efficacy of microneedling with CBD and hempseed oil for acne vulgaris [103].

4. dermatologytimes.com dermatologytimes.com/view/microneedling-produces-beneficial-acne-vulgaris-outcomes-without-disrupting-skin-structure-or-microbiome

Microneedling Produces Beneficial Acne Vulgaris ... All participants, aside from 1 patient, reported a 50% or higher improvement in the appearance of their acne. “Despite the lack of published ...

5. drkian.com drkian.com/acne-vulgaris-study

Acne Treatment Clinical Study A clinical study evaluating the effectiveness of microneedling with topical cannabidiol (CBD) in reducing inflammation, acne-causing bacteria, and improving ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/491235

Evaluating Microneedling With CBD and Hempseed Oil for ... This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06362889/evaluating-microneedling-with-cbd-and-hempseed-oil-for-acne-vulgaris-safety-and-efficacy

Evaluating Microneedling With CBD and Hempseed Oil for ... This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for ...

8. link.springer.com link.springer.com/article/10.1007/s40257-024-00891-y

The Potential Role of Cannabidiol in Cosmetic Dermatology NCT06362889 is a phase I study to evaluate the safety and efficacy of microneedling with CBD and hempseed oil for acne vulgaris [103].