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Cannabis-Derived Therapy
Microneedling with CBD oil for Acne
Phase 1
Waitlist Available
Led By Kian Karimi, MD
Research Sponsored by Rejuva Medical Aesthetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 70 days
Awards & highlights
Study Summary
This trial will investigate if microneedling with CBD and hempseed oil can safely and effectively treat moderate to severe acne in adults aged 22 or older. The study aims to see if using Heal
Who is the study for?
This trial is for adults aged 22 or older with moderate to severe facial acne. Specific eligibility criteria are not provided, but typically participants must be in good health and not have conditions that could interfere with the study.Check my eligibility
What is being tested?
The study is testing microneedling combined with CBD and hempseed oil to see if it's safe and effective for treating moderate to severe acne. It's an open-label study, meaning both researchers and participants know what treatment is being given.See study design
What are the potential side effects?
While specific side effects are not listed, common ones from microneedling can include redness, irritation, and swelling at the treatment site. CBD may cause fatigue or changes in appetite.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 70 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 70 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary efficacy endpoints
Secondary outcome measures
Secondary efficacy endpoints
Trial Design
1Treatment groups
Experimental Treatment
Group I: Microneedling with CBD oilExperimental Treatment1 Intervention
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.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Rejuva Medical AestheticsLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
HealMD, LLCIndustry Sponsor
Kian Karimi, MDPrincipal InvestigatorRejuva Medical Aesthetics
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment phase of this medical study currently ongoing?
"As per information available on clinicaltrials.gov, patient recruitment for this research project is presently closed. It was first listed on 5/1/2024 and last revised on 4/9/2024. Nonetheless, there are currently 38 alternative trials seeking participants."
Answered by AI
Has the FDA sanctioned the use of CBD oil in conjunction with microneedling?
"Given the preliminary nature of this study, our team at Power has rated the safety of Microneedling combined with CBD oil as a 1 on our scale."
Answered by AI
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