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| Name | Class |
|---|---|
| HealMD, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedling with CBD | Combination 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoints | Reduction in the Global Acne Severity Scale (GAS) grade by Primary Investigator Reduction in the GAS grade by the Subject | through study completion, approximately 70 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, approximately 70 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LaRyel Waldon, BS | Contact | 4246442400 | laryel@rejuvamedical.org | |
| Brian McDonnell, BS | Contact | 9492996747 | mcdonnellbrian7@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kian Karimi, MD | Rejuva Medical Aesthetics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rejuva Medical Aesthetics | Los Angeles | California | 90025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33469147 | Background | 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. | |
| 35535052 |
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All IPD that underlie results in a publication will be made available.
The Data will be made available within 6 months of the study's conclusion, and will remain available for at least 5 years.
Signing a data use agreement.
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
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| 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. |
| 31881765 | Background | 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. |
| 33168643 | Background | 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. |
| 30697147 | Background | 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. |
| 33629929 | Background | 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. |
| 25061872 | Background | 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. |
| 37799356 | Background | 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. |
| 33998871 | Background | 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. |
| 32597140 | Background | 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. |
| D012046 |
| Rehabilitation |