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NCT06362889 | NOT YET RECRUITING | Acne Vulgaris (Disorder)

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

Rejuva Medical Aesthetics

Brief 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.

Condition or disease

Acne Vulgaris (Disorder)

Intervention/treatment

Microneedling with CBD

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Exploratory Study to Evaluate the Safety and Efficacy of Microneedling With Cannabidiol (CBD) and Hempseed Oil for Treating Acne Vulgaris
Actual Study Start Date : 2025-12
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy

Location Details

NCT06362889

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Rejuva Medical Aesthetics

Los Angeles, California, United States, 90025