Monthly Archives: April 2022

Tyler Meyer felt foggy while taking several different medications throughout the day to help treat his insomnia.

My energy levels were off and that was just impacting everything I was doing, he said. Youre working seven days a week and all these things, it just really took a toll on me.

While he was a general manager at Indian Motorcycle of San Diego, Meyer decided to stop taking all of his pharmaceuticals and switch to natural solutions. He found his own natural concoction of resources and tried CBD.

When 2020 hit, he decided to leave the industry and start his own CBD business with his wife Kristina. The couple now owns Dakota Labs, a locally based organic CBD oil manufacturing business certified by the USDA.

The couple moved from California to Meyers hometown of Rapid City in December 2020. He said growing up in Rapid City, CBD and anything cannabis-related was very taboo.

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Just starting to see the attitude toward that change was really neat, Meyer said. We thought theres all kinds of stuff in California, the markets too saturated.

So they came home and brought the market, and education, to people who dont know too much about it. Kristina said theyre able to do pop-up shops and educate people about CBD. Meyer said education and having conversations about CBD oil is the majority of what they do at events or pop-up shops.

Meyer said it took about a year before the finished product was ready to go. He said he and Kristina worked with several different laboratories and formulators to determine the strengths and levels of the products.

Dakota Labs uses plants grown from farms in Montana and Colorado. Meyer said it took them a while to find the right farm to use, and focused on testing quality.

Kristina said all of the companys products are tested and each bottle features a QR code that customers can scan to see their lab results.

Meyer said they test for pesticides, heavy metals, cutting agents and the level of cannabinoids in each bottle. He said everything has to be less than 3% Delta-9 THC per net weight. Delta-9 THC is the psychoactive component of marijuana.

He also said the company has some products that have no THC, like their Broad Spectrum formula.

After farmers harvest the hemp, the plants are dried and then ground into a coarse powder. It is then shipped to a facility for processing. The company uses both medical-grade Ethanol extraction for signature formulas and CO2 extraction for the Full and Broad Spectrum formulas. For the latter two formulas, the company uses a purification process that involves supercritical CO2 that preserves phytocannabinoids, terpenes and flavonoids.

After processing, the hemp extract is separated from the CO2 or Ethanol compound and refined by removing compounds like wax, chlorophyll, pigments and other trace materials.

The products are then tested both in-house and using a third-party lab.

Meyer and Kristina said they both use their own products and have seen improvement in their sleep, anxiety and immune systems.

Meyer said hes the tester for any of their products, and thats one of the reasons they dont have a topical product yet. He said he hasnt found anything that works great on him, so if it doesnt work for him, hes not going to try to sell it.

I just wouldnt feel right about bringing something to market that I didnt really believe in, he said.

He said Dakota Labs will be releasing organic CBD gummies soon, and they are working on a topical solution. Dakota Labs products are carried at Black Hills Cultivation and Supply in Rapid City, Good Earth in Spearfish, and Back to Nature in Sturgis. Products are also available online at dakotalabs.com.

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Growing through the pain: Rapid City couple finds success in CBD oil - Rapid City Journal

A new Rockstar energy drink from Pepsi that contains hemp seed oil recently hit the shelvesbut members of the Navy were specifically warned on Wednesday that the beverage is off limits, claiming it will result in a positive drug test.

Regardless of the fact that hemp was federally legalized in 2018, and products containing its non-intoxicating derivatives like CBD are now widely available at grocery stores and gas stations across the country, military branches have made clear in a series of memos and warnings that service members arent allowed to partake.

But this latest advisory, which was sent by the Naval War Colleges (NWC) Drug and Alcohol Program Advisor and obtained by Marijuana Moment, is uniquely specific, calling attention to a single product thats emerged on the market while reminding members of the broader cannabis policy in effect.

Rockstar Energy now produces Rockstar Unplugged,' the advisory says, describing the product as a newer energy drink infused with hemp seed oil that will cause you and your Sailors to pop-positive on drug tests.

Rockstar is owned by PepsiCo.

Military branches have stressed that while hemp is now legal, the Food and Drug Administration (FDA) has not developed regulations allowing for the marketing of cannabinoid-infused foods or drinks. Therefore, there may be a risk of mislabeling that could lead service members to inadvertently consume detectable levels of THC on a drug test.

NWCs notice says definitively that the drink will cause a positive drug test, but thats questionable. Hemp seed oil on its own contains just trace amounts of CBD, let alone THC. And it stands to reason that a corporation as large as Pepsi would be especially cautious about introducing a product to the market that was prepared in a such a way that would put people at risk of testing positive for THC.

In any case, members of the Navy have been put on noticeagain.

Sailors and Marines are prohibited from using any product made or derived from hemp, including CBD, regardless of the products THC concentration, claimed or actual, and regardless of whether such product may lawfully be bought, sold, and used under the law applicable to civilians, the new message says. Please be mindful of the food / beverages you consume.

Gary Ross, a public affairs officer for NWC told Marijuana Moment that the new warning was an internally distributed email at the college.

Routine policy reminders are always excellent practice, he said.

Marijuana Moment reached out to Pepsi for comment as well, but a representative was not immediately available.

The militarys messaging on hemp and CBD has been fairly consistent, though some notices have raised more eyebrows than others.

For example, a Massachusetts base of the U.S. Air Force told pilots last year that they could face disciplinary action for possessing any type of hemp product, even if its for your pet.

The Navy, for its part, issued an initial notice in 2018 informing ranks that theyre barred from using CBD and hemp productsno matter their legality. Then in 2020 it released an updateexplaining why it enacted the rule change.

In 2019, the Department of Defense (DOD) announced a policybarring all active and reserve service members from using hemp products, including CBD. DOD more broadly reaffirmed that CBD is off limits to service members in earlier notices published in 2020.

About one year after hemp was federally legalized, the Air Force sent out a notice thatsimilarly warned against using CBD productsthat are commonly found on the market.

Officials with the military branch also said the previous year that it wants its members to be extra careful around grandmas miracle sticky bunsthat might contain marijuana.

The Coast Guard said thatsailors cant use marijuanaor visit state-legal dispensaries.

And NASA, which is not part of the military, warned that CBD productscould contain unauthorized THC concentrationsthat could cost employees their jobs if they fail a drug test.

A factor that may have influenced these policy updates is that the Substance Abuse and Mental Health Services Administration released guidance to federal agency drug program coordinatorsin 2019 that outlined concerns about THC turning up in CBD products and causing failed drug tests. The agencyissued an updated warning in 2020 after several more states voted to legalize marijuana.

Meanwhile, the U.S. Department of Veterans Affairs (VA) has separately faced criticism over its stance on cannabis issues.

Last month, for example, VA made clear that it wont provide support for treatment involving marijuana as part of a new grants program aimed at preventing veteran suicide.

VAs position on marijuana has been a source of consistent frustration for advocates and veteran service organizations who have been pushing for expanded research into the therapeutic potential of cannabis.

House and Senate committeesheld joint hearings last month to hear from veterans service organizations(VSOs) about how Congress and the federal government can better serve their constituents, and several of the groups brought up the need to ease restrictions on marijuana.

The testimony echoes what theVSOs have repeatedly raised with lawmakers. The specifics ranged in scope between the various groups, but the overall message was made clear: military veterans uniquely stand to benefit from marijuana treatment and its time for Congress to do something about it.

Separately, military veteranswould be encouraged to discuss medical marijuana treatment without the fear of losing federal benefits under a recent bill being sponsored by Rep. Seth Moulton (D-MA). The main thrust of the legislation is to codify existing policies that allow VA doctors to talk about medical cannabis with patients as well as protections for veterans who are candid about their history with marijuana treatment. By doing so, it would enshrine these polices into law so that they could not later be changed administratively by future VA leaders.

Meanwhile, as more states move to legalize marijuana, the director of national intelligence (DNI) said earlier this year that federal employers shouldnt outright reject security clearance applicants over past use and should use discretion when it comes to those with cannabis investments in their stock portfolios.

The Department of Transportation also took a different approach to its cannabis policy in 2020, stating in a notice that it would not be testing drivers for CBD.

And while the Biden administration has instituted a policy ofgranting waivers to certain workerswho admit to prior cannabis use, its come under fire from advocates following reports that it fired or otherwise punished dozens of staffers who were honest about their history with marijuana.

White House Press Secretary Jen Psaki has previouslyattempted to minimize the fallout, without much success, and her office released a statement last year stipulating that nobody was fired for marijuana usage from years ago,nor has anyone been terminated due to casual or infrequent use during the prior 12 months.

Meanwhile, FBI updated its hiring policies last year to make it so candidates are only automatically disqualified from joining the agency if theyadmit to having used marijuana within one yearof applying. Previously, prospective employees of the agency could not have used cannabis within the past three years.

A powerful congressional committeereleased a report last year that urges federal agencies to reconsider policies that result in the firing of employees who use marijuana legally in accordance with state law.

Read the full text of the NWC advisory on Rockstars hemp-infused energy drink below:

Subject: DAPA Note: Rockstar Energy Drinks infused with hemp seed oil

NWC Team,

See below for a product advisory for the new Rockstar Energy drink called Rockstar Unplugged.

BLUF: Rockstar Energy now produces Rockstar Unplugged. A newer energy drink infused with hemp seed oil that will cause you and your Sailors to pop-positive on drug tests.

DETAILS: On December 20, 2018, the President signed into law the Agriculture Improvement Act of 2018, removing industrial hemp from the Controlled Substances Act (21 U.S.C. 802(16)) and excluding from the definition of marijuana those hemp products containing up to 0.3 percent tetrahydrocannabinol (THC) on a dry weight basis. THC in marijuana and in hemp products containing more than 0.3 percent THC remain illegal. Due to this change in the law, new hemp products are commercially available in the United States, the normal use of which could cause a positive urinalysis result. The United States Food and Drug Administration (FDA) does not determine or certify the THC concentration of commercially available hemp products, such as cannabidiol (CBD). Accordingly, these products may contain appreciable levels of THC, yet omit any reference to THC on the product label and/or list an inaccurate THC concentration. Consequently, Sailors and Marines cannot rely on the packaging and labeling of hemp products in determining whether the product contains THC concentrations that could cause a positive urinalysis result.

Product information for Rockstar Unplugged can be found at: https://nypost.com/2022/02/01/pepsico-launches-hemp-infused-rockstar-energy-drink/

COMMENT: Sailors and Marines are prohibited from using any product made or derived from hemp, including CBD, regardless of the products THC concentration, claimed or actual, and regardless of whether such product may lawfully be bought, sold, and used under the law applicable to civilians. Please be mindful of the food / beverages you consume.

Very Respectfully,

U.S. Naval War College

Drug and Alcohol Program Advisor (DAPA)

States Collected More Than $3.7 Billion In Recreational Marijuana Tax Revenue In 2021, Report Finds

Photo courtesy of Flickr/U.S. Navy.

Original post:

Pepsi's Hemp-Infused Energy Drink Will Cause Sailors And Marines To Test Positive For Drugs, Navy College Claims - Marijuana Moment

Children who were exposed to cannabis in utero may be at risk for obesity and high blood sugar later in life, according to new research.

The study, which was published Thursday in the Journal of Clinical Endocrinology & Metabolism, measured cannabis levels in over 100 pregnant women and evaluated the health of their children around five years of age.

Of the children involved in the study, those who had been exposed to cannabis in the womb had a 2.6 percent greater fat mass and higher fasting glucose levels compared to those who werent exposed to cannabis in the womb.

The study adds to the growing evidence suggesting cannabis use in pregnancy may affect a babys health and interfere with their development.

I am not surprised that prenatal exposure to cannabis has [an] impact on the offspring. In principle, any significant pharmacological intervention (and cannabis is surely one) may impact the newborn either directly (by affecting the fetus) or indirectly (by affecting first the mother and then the fetus), Dr. Daniele Piomelli, the director of the University of California Irvine Center for the Study of Cannabis, told Healthline.

The study looked at 103 mother-child pairs living in Colorado.

The researchers collected urine samples from the pregnant women and found that 15 percent had detectable levels of cannabinoids, including THC and CBD, in their bodies, which suggests the fetuses had been exposed to the cannabinoids.

A follow-up visit was scheduled when the children were nearly five years old, at which point the children underwent blood draws after an overnight fast. The childrens fat mass was also measured.

The kids who had been exposed to cannabis in the womb were more likely to be at risk for obesity and high blood sugar.

Its unclear why fetal exposure to cannabis could have had this effect.

Piomelli says cannabis could interfere with the fetuss endogenous cannabinoid system or cannabis may impact the mothers behavior and physiology, altering the babys development.

Cannabis use among pregnant women has been increasing in the United States as more states have legalized the recreational use of cannabis, although overall rates remain very low.

From 2002 to 2017, self-reported use of cannabis during pregnancy jumped from 3.4 percent of pregnant women to 7 percent.

Previous research has linked maternal cannabis use to negative health outcomes in the baby.

Fetuses exposed to cannabis are more likely to develop Type 2 diabetes, obesity, and metabolic syndrome later in life.

Development and behavioral issues including visual problem-solving challenges and decreased attention span have been recorded in kids exposed to cannabis in utero as well.

Babies of active cannabis users are more likely to have intrauterine growth problems and low birth weight.

If cannabis is smoked frequently, this may cause lower oxygen levels in the bloodstream which in turn might perturb growth, Piomelli said, adding that we do not know if this applies to other forms of cannabis use like vaping or edibles.

According to Dr. S. Monty Ghosh, an assistant professor and doctor of internal medicine, disaster medicine, and addiction medicine at the University of Alberta, these findings mirror the impact of cigarette smoking during pregnancy.

It would be interesting [to] explore if this was related to smoking cannabis or ingested cannabis, Ghosh said.

Ghosh says the chemicals from cannabis may be able to cross the placenta and reach the fetus.

The American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), and the Academy of Breastfeeding Medicine (ABM) all advise against using cannabis products during pregnancy and lactation.

It is best and safest to resume smoking marijuana post lactation due to our limited understanding of the effects of cannabis on the child. Limiting secondhand exposure from cannabis smoke should be a priority, says Ghosh.

A new study has found that children who were exposed to cannabis, including CBD or THC, in utero may be at risk for obesity and high blood sugar later in life. The research adds to the growing evidence that cannabis use during pregnancy may be harmful to the babys health and interfere with their development.

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Children Exposed to Cannabis at Risk of High Blood Sugar - Healthline

High Times Cup competitions are a unique way for the industry to go up against the best of the best in the cannabis space not only for high THC but hemp products as well. The Hemp Cup: Peoples Choice 2022 unites both competitors and judges across the entire hemp space.

We are pleased to announce the High Times Hemp Cup winners, presented by Hemp Hop. Thank you to our Silver Sponsor, Orange County CBD, and to our Bronze Sponsor, Sweet Sensi CBD.

First Place: Flow Gardens Blue Cheese #12 Flower

Second Place: Healing Canopy White Triploid CBG Flower

Third Place: Grateful Beginnings Farm Sour Lifter Flower

First Place: Sweet Sensi CBD Improved Berry Blossom #17 Cigar

Second Place: Hemp Hop Pacific Cooler HHC Pre-Roll

Third Place: CBD Hemp Direct Honolulu Haze #3 Pre-Roll

First Place: Metta Hemp HHC Wet Sugar

Second Place: Alliance Hemp Co. Gas CBD Terpsolate

Third Place: Piur Select Tennessee Tangie Flower Sift Rosin

First Place: 3Chi Blue Dream HHC Vape

Second Place: STNR Tangie HHC Sativa Vape

Third Place: Rove Remedies Uplift Vape

First Place: Pow-Pow: OG Kush Blood Orange Live Resin Gummies

Second Place: Galaxy Treats Tropical Kush Moon Babies

Third Place: Martha Stewart Harvest Medley Wellness Gummies

First Place: Realize Citrus-Mango Drink Mix

Second Place: Buddys Chocolate Haus Hemp Oil Infused Mint Chocolate Bar

Third Place: Sweet Sensi CBD CBD Chocolate Truffles

First Place: By George! CBD CBD Salve

Second Place: Care Division Carefree Pain Relief Cream

Third Place: Horn Creek Hemp Redemption Body Recovery Oil

First Place: Rove Remedies Sleep Tincture

Second Place: Care Division Dream Sleep Aid Tincture

Third Place: Lifessence All Natural CBD Oil

First Place: Tayco R.S.O Capsules

Second Place: Vivimu #Relax CBN Softgels

First Place: Marys Tails Calm & Quiet Hemp Canine Chewables

Second Place: Mary Palmer Best Buds Bacon-Flavored CBD Dog Treats

Third Place: CBD Living Peanut Butter CBD Calming Support Dog Chews

First Place: Euphorica Maui Wowie D8:D10 Sativa Vape

Second Place: Rove Remedies D8 Vape

Third Place: Sugar Extrax Lemonade Kush D8:D10:THC-O Vape

First Place: Derived Creations Chewy Sea Salt Caramels

Second Place: 3Chi Watermelon Delta 8 THC Gummies

Third Place: JustCBD Delta 8 Peaches Interstellar Gummies

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The Winners of The Hemp Cup: People's Choice 2022 - High Times

By Julius Few, MD; Michael Lee, MD; Alec Semersky; Emily Mariscal, LE; and Ginny Vachon, PhD

This article originally appeared in the Aesthetic Surgery Journal.

Retinol is known to reduce the appearance of fine lines and wrinkles, but is associated with irritating effects. Cannabidiol (CBD) acts to reduce oxidative stress and inflammation, mitigating irritation from retinol, and further improving the skins appearance through independent anti-aging mechanisms.

Skin aging is influenced by a number of factors, including extrinsic factors like exposure to UV light, poor diet, or pollutants, and intrinsic factors such as collagen and elastin loss over time.1 Within the skin, intrinsic aging is due, in part, to the decreased capacity of keratinocytes, fibroblasts, and melanocytes to proliferate, and the degeneration of the fibrous extracellular matrix, while 80% of extrinsic aging can be attributed to UV radiation.2-4 Interestingly, for both intrinsic and extrinsic aging, reactive oxygen species (ROS) and associated oxidative stress can accelerate these processes in the skin through multiple mechanisms and contribute to dyspigmentation, reduced barrier function, laxity, and uneven texture.1-5 In addition, ROS are associated with inflammation, which can further negatively impact the skins appearance.5,6

In clinical practice, one of the few topical treatments for which there is strong clinical evidence of efficacy for reducing the signs of aging is retinol.7 The anti-aging effects of retinol are manifested by promoting proliferation of keratinocytes, strengthening the epidermis, and increasing collagen. However, retinol may indirectly decrease the antioxidative effects of the skin, leaving it prone to damage from ROS.8-10 Furthermore, skin reactions such as redness, drying, peeling, or burning associated with retinol treatment can lead to inconsistent use or discontinuation by patients.

In the current study, purified, water-soluble CBD was evaluated with 0.2% retinol as a combination product (CR-Topical, Afor, Chicago IL). By combining these agents, CR-Topical face cream was designed to combat both the intrinsic and extrinsic factors involved in skin aging by increasing skin turnover while protecting the skin through antioxidative and anti-inflammatory mechanisms, such that both efficacy and tolerability is improved.

In the current pilot study, due to the novelty of the combination and the need to characterize the impact of these treatments on the skin, a more granular approach was taken to measuring outcomes. Typically, aesthetic conditions are measured using validated and non-validated scales (e.g., FACE-Q, GAIS) using static photos taken from multiple angles.11,12 Subject satisfaction questionnaires may also be used to gauge perceptions of efficacy, satisfaction, and overall impressions. However, these scales are limited in their ability to detect specific changes to features such as skin quality. Therefore, the nine-domain Global Ranking Scale (GRS) and four-domain Skin Quality assessment was applied.13 The GRS is unique in that it is used as a collaborative tool by the physician with the patient, and therefore additional methods, described below, were used to confirm observations, including: blinded review and ordering of before and after images by a board-certified plastic surgeon, and inclusion of patient survey questions, which were completed independently, that overlap with GRS skin quality domains to confirm outcomes.

In addition to the capture of static images, this study evaluated patients using video of a series of facial expressions as an exploratory endpoint. Even the best before and after static images represent an incomplete picture of treatment efficacy. Moreover, optimal static correction can result in unnatural mimetic movement, overfilling, and/or inadequate or imbalanced correction. Compared with static images, dynamic videos are better able to capture global improvement across four dimensions, encompassing glide plane movement and multiple facial expressions (Table 1). The use of videos in this study was exploratory in nature and represents the first time that this four-dimensional beauty (4D Beauty, Afor, LLC, Chicago IL) assessment has been used in a clinical study. So much of how patients perceive themselves and are perceived by others is embedded in expressions, and even qualities like facial positioning and openness can be appreciated with video. This type of assessment is in its infancy, and development will likely involve extensive multidisciplinary research and development of novel measures, as well as protocols for video capture, however, its inclusion here paves the way for further development. In this pilot study, the use of 4D Beauty assessment is detailed, but is not part of the formal evaluation of efficacy. However, this work paves the way for use in clinical practice and study.13,14

Subjects who had botulinum toxin or filler within 3 months of study enrollment were excluded. Additionally, subjects who used topical, inhaled, or ingested cannabis and/or hemp-derived products including CBD or tetrahydrocannabinol within 30 days of the study start date or during the study period were excluded. Further key exclusionary characteristics included facial rejuvenation procedures (e.g., chemical peels, microneedling, microdermabrasion, etc.); pregnancy; advanced or poorly controlled diabetes; current smoker or history of heavy smoking; the use of anti-inflammatory topical products during the study period; or regular continuous use of systemic or topical corticosteroids on the area to be treated.

The primary efficacy endpoint consisted of clinical evaluations of the face based on comparison of GRS scores at each time point, compared to baseline, as well as qualitative comparison of standardized before and after photographs on days 1, 21, and 42. During visits on day 1 (baseline), 21, and 42, standardized photographs of the treatment areas were taken and global skin appearance was assessed using the GRS with Comprehensive Skin Analysis by joint evaluation of severity by the lead investigator and the subject (Figure 1).13

Note, the investigator and subject were blinded to their original assessment scores at the time of evaluation. Each of the scales 13 domains, including loss of elasticity, surface roughness, dehydration, static and dynamic wrinkles, volume loss, sagging, asymmetry, imbalance, scar presence, visible pores, pigmentation, and vasculature, were graded from 0-3 (0, none; 1, mild; 2, moderate; 3, severe), and mean scores at baseline and at 42 days were calculated for each domain and compared.13 Paired mean difference with each subject used as their own control, and lower and upper 95% confidence intervals for each domain was calculated. Due to the small number of subjects and the use of a 4-point scale across numerous domains, paired t-tests with p-values are less informative (p-values calculated using a paired two-tailed t-test were significant for all measures assessed), and are not presented here.

Because the GRS is intended to be used as a collaborative tool by the physician with the patient, it is not conducive to blinded review. Instead, a blinded reviewer was asked to order the static baseline and 42-day images as before and after, and percent agreement with whether the actual photograph was taken at baseline or day 42 was calculated. In addition, questions overlapping with GRS skin quality domains were included in the subject questionnaire to confirm outcomes. These questionnaires were completed by subjects independently, following completion of the GRS.

Secondary efficacy endpoints included subject observations from satisfaction questionnaires regarding major cutaneous changes such as smoothness, irritation, pruritus, burning, and erythema. Exploratory endpoints included the use of 4D assessment as an assessment tool for qualitative measure of dynamic and animation-related patient features. On days 21 and 42, daily subject diaries were reviewed for compliance and tolerability, and subjects completed an 8-question satisfaction survey. Filmed video evaluations occurred on days 1 and 42 for 4D assessment.

Safety was monitored by the investigator through application site assessment during each follow-up visit (days 1, 21, and 42). Because of the established propensity for retinol to cause irritation, an additional, virtual safety assessment of the application site occurred on day 3. At each follow-up visit, study medication tubes were weighed for compliance. This study was IRB approved (Advarra IRB, Columbia, MD) and adhered to the Good Clinical Practice and standards set forth in the World Medical Associations Declaration of Helsinki. Written consent was provided, by which the patients agreed to the use and analysis of their data.

At 42 days, GRS with Comprehensive Skin Analysis score improvement was observed from baseline to day 42 across all 13 domains, including domains for which improvement was unexpected (e.g., sagging). While improvement was consistent, some areas improved more than others, generally those most consistent with a topical treatment (Figure 2). Among subjects, the highest mean scores at baseline were visible pores (2.6), dynamic wrinkles (2.5), surface roughness (2.4), pigmentation (2.3), and static wrinkles (2.1); Higher mean scores correlate to worse skin quality [0, none; 1, mild; 2, moderate; 3, severe]).

When assessing the relative degree of improvement for each domain, those with 1-point improvement from day 0 to day 42 were found to be consistent with topical treatments (Figure 3, black dotted line). While statistically significant changes were observed for each domain, including both the GRS and skin quality measures, the areas of greatest change were visible pores (2.0-point change; 95% CI, 1.5-2.5), dehydration (2.0-point change; 95% CI, 1.4-2.6), surface roughness (1.8-point change; 95% CI, 1.2-2.4) static wrinkles (1.8-point change; 95% CI, 1.1-2.5), and dynamic wrinkles (1.6-point change; 95% CI, 0.8-2.3). Notably, while the greatest possible score change is 3, not all subjects began with severe skin quality, making a 3-point change impossible. However, a two-point change represents a change from severe to mild or moderate to none, both of which represent very impactful improvements.

Each subject who reported severe static wrinkles, dynamic wrinkles, surface roughness, scars, visible pores or vasculature at baseline reported at least mild severity for these domains at study completion. Moreover, all subjects with severe dehydration reported none at the end of the study. The blinded reviewer correctly ordered before and after images for 80% of the subjects.

Satisfaction and functional outcomes assessed using subject questionnaires completed on days 21 and 42 revealed that at day 42, 90% of subjects either agreed (50%) or strongly agreed (40%) that they experienced visible reduction of facial fine lines and wrinkles (Figure 4). Overall, 100% of subjects felt that CR-Topical made them more confident in the physical appearance of their face. In agreement with GRS outcomes, subjects strongly agreed that the use of CR-Topical significantly improved the texture/smoothness (90%) and pore size (70%) of the skin, outcomes consistent with those measured with the GRS. Subjects either agreed or strongly agreed (30% vs 70%, respectively) with the statement that they experienced minimal irritation for the duration of the study, demonstrating the excellent tolerability of CR-Topical. Furthermore, 90% of subjects strongly agreed that they were very satisfied with the product, with 90% expressing both their willingness to use CR-Topical again and recommend the cream to family and friends.

Representative patient images illustrate improvement across a range of GRS domains (Figure 5). Changes in skin quality are apparent in before and after images and show a close-up view of patients so that changes in skin quality can be appreciated.

Although research on CBD oil as a topical agent is still emerging, supplementary use has been shown to decrease inflammation and improve therapeutic outcomes for severe inflammatory skin diseases, supporting this potential role.16-18 Anecdotally, the improvements observed for the combination of retinol and water-soluble CBD are better than for either product alone, suggesting an additive, or potentially synergistic benefit. Larger controlled studies will need to be carried out in order to understand the relative effects of CR-Topical and retinol, and to define any synergistic activity for the two ingredients. Importantly in these studies, a larger number of patients should be followed for an extended period of time to best understand the impact of treatment.

When considering the potential for synergistic activity, the mechanism of action for both retinol and CBD is informative. Through the combined effects of promoting cell proliferation and reducing oxidative stress, these agents may work synergistically to combat both the extrinsic and intrinsic causes of aging. While the mechanism of action of CBD in the skin has yet to be fully elucidated, its antioxidant and anti-inflammatory activities are well recognized, and can be partially attributed to its activation of Nrf2-target activation genes, including HMOX1, which plays crucial roles in modulating inflammation, apoptosis, and oxidative stress.19

Importantly, CBD-induced activation of HMOX1 expression occurs through a Nrf2-independent mechanism.19 Because retinol suppresses expression of Nrf2-target antioxidative genes, the addition of CBD oil can potentially restore antioxidative effects inhibited by retinol while allowing for retention of skin strengthening properties.8,10,18 This activity of CBD is in addition to independent mechanisms, including modulation of the human endocannabinoid system (ECS), which is linked to anti-aging effects through its role in maintaining skin homeostasis and barrier function, antioxidant and anti-inflammatory activity, as well as optimal sebum production.18-20

For retinol, independent effects are manifested through promoting keratinocyte proliferation, strengthening of the epidermis and increasing collagen (through protection of existing collagen and stimulation of neocollagenesis) in the skin.8,9 Importantly, the combination of CBD and retinol appears to reduce skin irritation often observed with retinol alone. Notably, 100% of subjects who reported severe dehydration at baseline reported none at the conclusion of the study, indicating that CBD may combat the irritation characteristic of retinol topicals, providing considerable benefit to subject tolerability and indirect improvement in efficacy due to increasing the likelihood of adherence. Importantly, the CBD used in this study is water soluble. Most often, CBD is administered dissolved in oil, commonly coconut oil or medium-chain triglyceride (MCT) oil. The absence of oils in this formulation that could potentially clog pores or otherwise irritate skin is also an important contributor.

While improvement across all 13 domains for all subjects suggests a global effect of CR-Topical, improvements in areas such as sagging or asymmetry may signal some variability in day-to-day perceptions, some level of bias that stems from the investigator and the subject completing the assessment together, or incomplete ability of the subject to differentiate entirely between the contributions of individual domains to overall global improvement. In future studies, placebo control and blinding both the subject and evaluating investigator will shed light on this topic. Additionally, when interpreting results, it is important to consider that the rating scale ranged from 0 to 3. Therefore, seemingly modest changes (e.g., severe at 3 to mild at 1) do indeed reflect a significant improvement. Because of the granular nature of the GRS scale, it is possible that future studies could also evaluate combination treatment with other products or modalities versus monotherapy, further characterizing the effects of distinct interventions on global outcome when used together.

As skin treatments continue to emerge and become increasingly multi-modal in nature, it is essential to better understand the specific effects that different treatments have on the skin. While historical measurements for skin treatment efficacy have relied on static imagery, this methodology cannot capture the movement of glide planes and facial expressions, and it is how our faces move during communication that most informs perceptions of beauty. Capturing movements of the face with short videos more accurately reflects what is observed in day-to-day life as opposed to static imagery, and provides a real-world context for evaluating the most relevant effects of treatment. This novel and dynamic 4D assessment may prevent overcorrection or unnatural looking results by encouraging consideration of youthful dynamics in expression as well as facial proportion.21 Further, 4D assessment can be used in conjunction with new or existing scales and opens the door for incorporation of new measures rating naturalness of outcomes, projection or correction across multiple facial expressions, apparent confidence, openness, or other characteristics that are not traditionally thought of as study outcomes. Moreover, subjects can use the videos to better evaluate their overall satisfaction and experience by observing their facial movements before and after treatment. Like the GRS, 4D assessment can be used as a tool for patient education, treatment planning, and encouraging pursuit of natural-looking results. The exploratory assessment using 4D dynamic imagery in this study revealed that video documentation and 4D beauty is an important element of a comprehensive efficacy profile for any product or device and paved the way for video and dynamic assessments as measures of treatment effect.

Shortcomings of this study include the small sample size and short duration of follow-up time. A larger cohort and increased length of the study could lead to more robust results, especially if the design includes a control group or is a split-face study. Future studies will compare the efficacy of CR-Topical with retinol alone.

When used in combination, water-soluble CBD and retinol offer significant improvements in skin quality, as well as in static and dynamic lines, with minimal irritation. Synergistic activity of CBD and retinol may explain this high level of efficacy. Additionally, a more granular assessment of aesthetic outcomes is long overdue and should be incorporated into future clinical studies evaluating topical skin treatments. Dynamic, 4D beauty assessment is a newly emerging mode of evaluation that could be fully developed and applied to better capture the effects of treatment.

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A Single-Center Study Evaluating the Effects of a Novel Retinol and Cannabidiol Combination Topical - Beauty Packaging Magazine