Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy
NCT ID: NCT06362889
Last Updated: 2024-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-12-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Microneedling with CBD oil
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.
Microneedling with CBD
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
Interventions
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Microneedling with CBD
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
ALL
Yes
Sponsors
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HealMD, LLC
INDUSTRY
Rejuva Medical Aesthetics
OTHER
Responsible Party
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Principal Investigators
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Kian Karimi, MD
Role: PRINCIPAL_INVESTIGATOR
Rejuva Medical Aesthetics
Locations
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Rejuva Medical Aesthetics
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Peyravian 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.
Atalay 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.
Nachnani 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.
Muller 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.
Huang 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.
Olah 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.
Alqam 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.
Land 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.
Cerne 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.
Other Identifiers
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HealMD-CBD-1
Identifier Type: -
Identifier Source: org_study_id
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