Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy
- Conditions
- Acne Vulgaris (Disorder)
- Registration Number
- NCT06362889
- Lead Sponsor
- Rejuva Medical Aesthetics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria:<br><br> - Male or non-pregnant, non-lactating female, 22 years of age or older. Females of<br> childbearing potential must agree to the use of a reliable method of contraception<br> throughout the study.<br><br> - Have a Global Acne Severity Scale Score of 3 (Moderate), 4 (Severe), or 5 (Very<br> severe).<br><br> - Have no plans to begin a new skincare routine or medical treatment program<br> (Accutane) through the course of the study.<br><br> - Willing to abstain from any aesthetic or surgical procedure in the treatment area<br> for the duration of the study.<br><br>Exclusion Criteria:<br><br> - Significant history or current evidence of any uncontrolled chronic or serious<br> disease or medical condition that would, in the judgment of the investigator, would<br> put the subject at undue risk or compromise the study assessments.<br><br> - Employees of the Investigator or research center or their immediate family members.<br><br> - Inability to understand the requirements of the study and the relative information<br> and are unable or not willing to comply with the study protocol.<br><br> - The use of Accutane (Isotretinoin) within 6-months.<br><br> - The use of topical or oral therapies that include benzoyl peroxide, azelaic acid,<br> salicylic acid, and hydroquinone 30 days prior to study entry.<br><br> - Exposure to any other investigational drug/device within 30 days prior to study<br> entry.<br><br> - Sunburned at time of anticipated treatment. Subject must also be willing to avoid<br> significant sun exposure throughout participation<br><br> - Recent facial plastic surgery, aesthetic treatment, or dermatological treatment at<br> treatment sites that would interfere with ability to receive microneedling.<br><br> - Facial hair that would interfere with the visualization of treatment sites.<br><br> - Subject with abnormal vision assessments.<br><br> - Subject is known to be noncompliant or is unlikely to comply with the requirements<br> of the study protocol (e.g. due to alcoholism, drug dependency, mental incapacity)<br> in the opinion of the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoints
- Secondary Outcome Measures
Name Time Method Secondary efficacy endpoints