Clinical trial NCT06362889: Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy
Official title: An Exploratory Study to Evaluate the Safety and Efficacy of Microneedling With Cannabidiol (CBD) and Hempseed Oil for Treating Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Acne Vulgaris (Disorder)
Lead sponsor: Rejuva Medical Aesthetics
Sponsor class: OTHER
Collaborators: name: HealMD, LLC
First posted: 2024-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Primary efficacy endpoints
timeFrame: through study completion, approximately 70 days
Secondary outcomes:
measure: Secondary efficacy endpoints
timeFrame: through study completion, approximately 70 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Rejuva Medical Aesthetics
state: California
Study officials:
affiliation: Rejuva Medical Aesthetics
name: Kian Karimi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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