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NCT Number: NCT06362889

Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non-pregnant, non-lactating female, 22 years of age or older. Females of childbearing potential must agree to the use of a reliable method of contraception throughout the study.
  • Have a Global Acne Severity Scale Score of 3 (Moderate), 4 (Severe), or 5 (Very severe).
  • Have no plans to begin a new skincare routine or medical treatment program (Accutane) through the course of the study.
  • Willing to abstain from any aesthetic or surgical procedure in the treatment area for the duration of the study.

Exclusion criteria

  • Significant history or current evidence of any uncontrolled chronic or serious disease or medical condition that would, in the judgment of the investigator, would put the subject at undue risk or compromise the study assessments.
  • Employees of the Investigator or research center or their immediate family members.
  • Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
  • The use of Accutane (Isotretinoin) within 6-months.
  • The use of topical or oral therapies that include benzoyl peroxide, azelaic acid, salicylic acid, and hydroquinone 30 days prior to study entry.
  • Exposure to any other investigational drug/device within 30 days prior to study entry.
  • Sunburned at time of anticipated treatment. Subject must also be willing to avoid significant sun exposure throughout participation
  • Recent facial plastic surgery, aesthetic treatment, or dermatological treatment at treatment sites that would interfere with ability to receive microneedling.
  • Facial hair that would interfere with the visualization of treatment sites.
  • Subject with abnormal vision assessments.
  • Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g. due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Treatment and study plan

Microneedling with CBD

Combination Product

Cannabidiol (CBD) Isolate- 90-100mg / 1mL of carrier oil Organic Hemp Seed Oil- used as carrier oil for CBD isolate in Combination with Microneedling Device

Primary outcomes

  1. Primary efficacy endpoints

    Time frame: through study completion, approximately 70 days

    Reduction in the Global Acne Severity Scale (GAS) grade by Primary Investigator Reduction in the GAS grade by the Subject

Secondary outcomes

  1. Secondary efficacy endpoints

    Time frame: through study completion, approximately 70 days

    Improvement in the appearance of acne vulgaris papules and comedones in standardized photographs Monitoring for Adverse Events and Serious Adverse Events at all study visits

Study contacts

Contact information is provided by the study sponsor or research team.

Brian McDonnell, BS

CONTACT

[email protected]

9492996747

LaRyel Waldon, BS

CONTACT

[email protected]

4246442400

Sponsors and collaborators

Lead sponsor

Rejuva Medical Aesthetics

Other

Collaborators

  • HealMD, LLC

Registry information

Official study title

An Exploratory Study to Evaluate the Safety and Efficacy of Microneedling With Cannabidiol (CBD) and Hempseed Oil for Treating Acne Vulgaris

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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