Acne Vulgaris (Disorder)Phase 1NCT06362889
Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy
A Phase 1 study testing Microneedling with CBD in people with Acne Vulgaris (Disorder), run by Rejuva Medical Aesthetics at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris (Disorder)
- What is being tested?
- Microneedling with CBD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Rejuva Medical Aesthetics
Los Angeles, California, 90025
LaRyel A Waldon, B.S., 424-644-2400, laryel@rejuvamedical.org
Margaux Oldfield, 4246442400, margaux@rejuvamedical.org
About this study
Official title: An Exploratory Study to Evaluate the Safety and Efficacy of Microneedling With Cannabidiol (CBD) and Hempseed Oil for Treating Acne Vulgaris
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.
- Conditions
- Acne Vulgaris (Disorder)
- Being tested
- Microneedling with CBD
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling with CBDCombination product
Cannabidiol (CBD) Isolate- 90-100mg / 1mL of carrier oil Organic Hemp Seed Oil- used as carrier oil for CBD isolate in Combination with Microneedling Device
| Study group | Role | What they receive |
|---|---|---|
| Microneedling with CBD oil | Experimental | 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. Receives: Combination Product: Microneedling with CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoints
Reduction in the Global Acne Severity Scale (GAS) grade by Primary Investigator Reduction in the GAS grade by the Subject
Measured: through study completion, approximately 70 days
Secondary outcomes (1)
Secondary efficacy endpoints
Improvement in the appearance of acne vulgaris papules and comedones in standardized photographs Monitoring for Adverse Events and Serious Adverse Events at all study visits
Measured: through study completion, approximately 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study startDec 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acne Vulgaris (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rejuva Medical Aesthetics
- Sponsor type
- University, hospital or other
- Collaborators
- HealMD, LLC
- Responsible party
- Sponsor
- Investigators
- Kian Karimi, MD, Principal investigator, Rejuva Medical Aesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362889
- Sponsor's protocol ID
- HealMD-CBD-1
- Status last verified
- Aug 2024
- First submitted
- 5 Apr 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be made available.
Publications
Blaskovich MAT, Kavanagh AM, Elliott AG, Zhang B, Ramu S, Amado M, Lowe GJ, Hinton AO, Pham DMT, Zuegg J, Beare N, Quach D, Sharp MD, Pogliano J, Rogers AP, Lyras D, Tan L, West NP, Crawford DW, Peterson ML, Callahan M, Thurn M. The antimicrobial potential of cannabidiol. Commun Biol. 2021 Jan 19;4(1):7. doi: 10.1038/s42003-020-01530-y.
PubMed 33469147Peyravian N, Deo S, Daunert S, Jimenez JJ. The Anti-Inflammatory Effects of Cannabidiol (CBD) on Acne. J Inflamm Res. 2022 May 3;15:2795-2801. doi: 10.2147/JIR.S355489. eCollection 2022.
PubMed 35535052Atalay S, Jarocka-Karpowicz I, Skrzydlewska E. Antioxidative and Anti-Inflammatory Properties of Cannabidiol. Antioxidants (Basel). 2019 Dec 25;9(1):21. doi: 10.3390/antiox9010021.
PubMed 31881765Nachnani R, Raup-Konsavage WM, Vrana KE. The Pharmacological Case for Cannabigerol. J Pharmacol Exp Ther. 2021 Feb;376(2):204-212. doi: 10.1124/jpet.120.000340. Epub 2020 Nov 9.
PubMed 33168643Muller C, Morales P, Reggio PH. Cannabinoid Ligands Targeting TRP Channels. Front Mol Neurosci. 2019 Jan 15;11:487. doi: 10.3389/fnmol.2018.00487. eCollection 2018.
PubMed 30697147Huang T, Xu T, Wang Y, Zhou Y, Yu D, Wang Z, He L, Chen Z, Zhang Y, Davidson D, Dai Y, Hang C, Liu X, Yan C. Cannabidiol inhibits human glioma by induction of lethal mitophagy through activating TRPV4. Autophagy. 2021 Nov;17(11):3592-3606. doi: 10.1080/15548627.2021.1885203. Epub 2021 Feb 25.
PubMed 33629929Olah A, Toth BI, Borbiro I, Sugawara K, Szollosi AG, Czifra G, Pal B, Ambrus L, Kloepper J, Camera E, Ludovici M, Picardo M, Voets T, Zouboulis CC, Paus R, Biro T. Cannabidiol exerts sebostatic and antiinflammatory effects on human sebocytes. J Clin Invest. 2014 Sep;124(9):3713-24. doi: 10.1172/JCI64628. Epub 2014 Jul 25.
PubMed 25061872Alqam ML, Jones BC, Hitchcock TM. Study to determine the safety and efficacy of microneedling as an effective treatment for acne vulgaris. Skin Health Dis. 2023 Jul 5;3(5):e264. doi: 10.1002/ski2.264. eCollection 2023 Oct.
PubMed 37799356Land MH, Toth ML, MacNair L, Vanapalli SA, Lefever TW, Peters EN, Bonn-Miller MO. Effect of Cannabidiol on the Long-Term Toxicity and Lifespan in the Preclinical Model Caenorhabditis elegans. Cannabis Cannabinoid Res. 2021 Dec;6(6):522-527. doi: 10.1089/can.2020.0103. Epub 2020 Nov 20.
PubMed 33998871Cerne K. Toxicological properties of Delta9-tetrahydrocannabinol and cannabidiol. Arh Hig Rada Toksikol. 2020 Mar 1;71(1):1-11. doi: 10.2478/aiht-2020-71-3301.
PubMed 32597140
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Safety and Efficacy of Microneedling With Cannabidiol (CBD) and Hempseed Oil for Treating Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06362889
- Acronym / sponsor ID
- HealMD-CBD-1
- Conditions
- Acne Vulgaris (Disorder)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rejuva Medical AestheticsUniversity, hospital or other
- Collaborators
- HealMD, LLC
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microneedling with CBD oil | Experimental | Combination Product: Microneedling with CBDAll 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedling with CBDCannabidiol (CBD) Isolate- 90-100mg / 1mL of carrier oil Organic Hemp Seed Oil- used as carrier oil for CBD isolate in Combination with Microneedling Device | Combination product | Microneedling with CBD oil |
Primary outcome
Primary efficacy endpoints
Time frame: through study completion, approximately 70 days
Reduction in the Global Acne Severity Scale (GAS) grade by Primary Investigator Reduction in the GAS grade by the Subject
1 secondary outcome
Secondary efficacy endpoints
Time frame: through study completion, approximately 70 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 33469147Blaskovich MAT, Kavanagh AM, Elliott AG, Zhang B, Ramu S, Amado M, Lowe GJ, Hinton AO, Pham DMT, Zuegg J, Beare N, Quach D, Sharp MD, Pogliano J, Rogers AP, Lyras D, Tan L, West NP, Crawford DW, Peterson ML, Callahan M, Thurn M. The antimicrobial potential of cannabidiol. Commun Biol. 2021 Jan 19;4(1):7. doi: 10.1038/s42003-020-01530-y.
- Background: PubMed 35535052Peyravian N, Deo S, Daunert S, Jimenez JJ. The Anti-Inflammatory Effects of Cannabidiol (CBD) on Acne. J Inflamm Res. 2022 May 3;15:2795-2801. doi: 10.2147/JIR.S355489. eCollection 2022.
- Background: PubMed 31881765Atalay S, Jarocka-Karpowicz I, Skrzydlewska E. Antioxidative and Anti-Inflammatory Properties of Cannabidiol. Antioxidants (Basel). 2019 Dec 25;9(1):21. doi: 10.3390/antiox9010021.
- Background: PubMed 33168643Nachnani R, Raup-Konsavage WM, Vrana KE. The Pharmacological Case for Cannabigerol. J Pharmacol Exp Ther. 2021 Feb;376(2):204-212. doi: 10.1124/jpet.120.000340. Epub 2020 Nov 9.
- Background: PubMed 30697147Muller C, Morales P, Reggio PH. Cannabinoid Ligands Targeting TRP Channels. Front Mol Neurosci. 2019 Jan 15;11:487. doi: 10.3389/fnmol.2018.00487. eCollection 2018.
- Background: PubMed 33629929Huang T, Xu T, Wang Y, Zhou Y, Yu D, Wang Z, He L, Chen Z, Zhang Y, Davidson D, Dai Y, Hang C, Liu X, Yan C. Cannabidiol inhibits human glioma by induction of lethal mitophagy through activating TRPV4. Autophagy. 2021 Nov;17(11):3592-3606. doi: 10.1080/15548627.2021.1885203. Epub 2021 Feb 25.
- Background: PubMed 25061872Olah A, Toth BI, Borbiro I, Sugawara K, Szollosi AG, Czifra G, Pal B, Ambrus L, Kloepper J, Camera E, Ludovici M, Picardo M, Voets T, Zouboulis CC, Paus R, Biro T. Cannabidiol exerts sebostatic and antiinflammatory effects on human sebocytes. J Clin Invest. 2014 Sep;124(9):3713-24. doi: 10.1172/JCI64628. Epub 2014 Jul 25.
- Background: PubMed 37799356Alqam ML, Jones BC, Hitchcock TM. Study to determine the safety and efficacy of microneedling as an effective treatment for acne vulgaris. Skin Health Dis. 2023 Jul 5;3(5):e264. doi: 10.1002/ski2.264. eCollection 2023 Oct.
- Background: PubMed 33998871Land MH, Toth ML, MacNair L, Vanapalli SA, Lefever TW, Peters EN, Bonn-Miller MO. Effect of Cannabidiol on the Long-Term Toxicity and Lifespan in the Preclinical Model Caenorhabditis elegans. Cannabis Cannabinoid Res. 2021 Dec;6(6):522-527. doi: 10.1089/can.2020.0103. Epub 2020 Nov 20.
- Background: PubMed 32597140Cerne K. Toxicological properties of Delta9-tetrahydrocannabinol and cannabidiol. Arh Hig Rada Toksikol. 2020 Mar 1;71(1):1-11. doi: 10.2478/aiht-2020-71-3301.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kian Karimi, MD principal investigator
Rejuva Medical Aesthetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microneedling with CBD in people with Acne Vulgaris (Disorder), run by Rejuva Medical Aesthetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LaRyel Waldon, BS (4246442400, laryel@rejuvamedical.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoints (time frame: through study completion, approximately 70 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06362889, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.