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

Last updated: August 21, 2024
Sponsor: Rejuva Medical Aesthetics
Overall Status: Active - Not Recruiting

Phase

1

Condition

Inflammatory Comedones

Acne

Rash

Treatment

Microneedling with CBD

Clinical Study ID

NCT06362889
HealMD-CBD-1
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or non-pregnant, non-lactating female, 22 years of age or older. Females ofchildbearing potential must agree to the use of a reliable method of contraceptionthroughout the study.

  • Have a Global Acne Severity Scale Score of 3 (Moderate), 4 (Severe), or 5 (Verysevere).

  • 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 areafor the duration of the study.

Exclusion

Exclusion Criteria:

  • Significant history or current evidence of any uncontrolled chronic or seriousdisease or medical condition that would, in the judgment of the investigator, wouldput 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 informationand 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 studyentry.

  • Sunburned at time of anticipated treatment. Subject must also be willing to avoidsignificant sun exposure throughout participation

  • Recent facial plastic surgery, aesthetic treatment, or dermatological treatment attreatment 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 requirementsof the study protocol (e.g. due to alcoholism, drug dependency, mental incapacity)in the opinion of the investigator.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Microneedling with CBD
Phase: 1
Study Start date:
December 01, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Rejuva Medical Aesthetics

    Los Angeles, California 90025
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.