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

Rejuva Medical Aesthetics

Status and phase: Begins enrollment in 11 months; Phase 1

Conditions: Acne Vulgaris (Disorder)

Treatments: Combination Product: Microneedling with CBD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06362889

HealMD-CBD-1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Microneedling with CBD oil

Experimental group

Description:

All subjects will receive microneedling with CBD oil.At the baseline visit, the subject will undergo treatment by the principal investigator or subinvestigator. 3 days from the treatment visit, a phone call visit will be placed to assess any safety events and adherence to protocol guidelines. Day 21 visit, several assessments will be recorded and if no adverse events are reported related to the study device and/or procedure, a second treatment will be performed. After 3 days from the treatment visit, a phone call will be placed to assess any safety events. Subjects will have subjective assessments and photographs taken at all visits. At day 42, the subject will return for a third treatment if no adverse events related to the study device and/or procedure are reported. After 3 days from the treatment visit, a phone call will be placed to assess any safety events. On day 63,no treatment to be performed, only a safety assessment, standardized assessments/questionnaires and photography.

Treatment:

Combination Product: Microneedling with CBD