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

Launched by REJUVA MEDICAL AESTHETICS · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a treatment for moderate to severe acne using a method called microneedling combined with CBD (cannabidiol) and hempseed oil. This study aims to see if this combination can help improve the appearance of acne in adults aged 22 and older. It’s a single-center study, meaning it will take place at one location, and it is currently not recruiting participants.

To be eligible for the trial, participants must be men or non-pregnant women over 22 years old and have a certain level of acne severity. They should not be planning to start any new skincare treatments or procedures during the study and must agree to use reliable birth control if they are able to have children. Participants can expect to undergo microneedling treatments and will need to avoid sun exposure and certain medications that could interfere with the study. Importantly, anyone with specific health issues or recent cosmetic procedures may not qualify. This trial could offer a new approach to treating acne, but all participants should be aware of the requirements and commitments involved.

Gender

ALL

Eligibility 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.