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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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 of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne.

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 data supports the effectiveness of the treatment Microneedling with CBD for Acne?

Research shows that microneedling is effective for treating acne scars by promoting collagen production, which helps improve skin texture. While there is no direct evidence for microneedling with CBD specifically for acne, microneedling alone has shown promising results in improving acne-related skin issues. ^{1 2 3 4 5}

Is microneedling with CBD safe for humans?

Microneedling is generally considered safe for various skin conditions, with mild and temporary side effects like slight skin irritation or redness. There are few reports of more serious reactions, such as post-inflammatory hyperpigmentation (dark spots) or allergic reactions, but these are rare. ^{3 6 7 8 9}

How does the treatment Microneedling with CBD for Acne differ from other treatments?

Microneedling with CBD is unique because it combines microneedling, a technique that stimulates collagen production to improve acne scars, with CBD, which may have anti-inflammatory properties. This combination aims to enhance skin healing and reduce inflammation, potentially offering a novel approach compared to traditional acne treatments that often focus solely on eliminating bacteria. ^{1 2 3 6 10}

Research Team

Kian Karimi, MD

Principal Investigator

Rejuva Medical Aesthetics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Study to determine the safety and efficacy of microneedling as an effective treatment for acne vulgaris. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Microneedling Therapy for Atrophic Acne Scars: An Objective Evaluation. [2022]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Efficacy Of Micro-Needling On Post Acne Scars. [2023]

4. India pubmed.ncbi.nlm.nih.gov

An objective assessment of microneedling therapy in atrophic facial acne scars. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Combined Effect of Microneedling and Platelet-Rich Plasma for the Treatment of Acne Scars: A Meta-Analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Microneedling as a Treatment for Acne Scarring: A Systematic Review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Microneedling in All Skin Types: A Review. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Dermatotoxicology of microneedles (MNs) in man. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Acne and its post-inflammatory hyperpigmentation treatment by applying anti-acne dissolving microneedle patches. [2023]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Two Cases of Treatment of Moderate to Severe Acne with an Acupuncture-Debridement Microsurgical Technique and Review of the Literature. [2023]