Effect of Topical CBD Cream for Degenerative Hallux Disorders

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Rush University Medical Center

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a CBD cream applied to the skin to see if it can reduce pain and inflammation in patients with chronic foot conditions called hallux rigidus and hallux valgus.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Magnesium-Cannabidiolic Acid Cream treatment?

Research suggests that cannabidiol (CBD) and cannabidiolic acid (CBDA) have anti-inflammatory and pain-relieving effects, which may help with conditions like skin disorders and muscle soreness. Additionally, studies on similar cannabinoid-based treatments have shown promise in improving symptoms such as pain and inflammation. ^{1 2 3 4 5}

Is the Magnesium-Cannabidiolic Acid Cream safe for use in humans?

Research on similar cannabinoid products suggests they are generally well tolerated with few serious side effects. Some users report mild issues like dry mouth, sleepiness, or increased appetite, but most do not experience significant adverse effects. ^{2 5 6 7 8}

How does Magnesium-Cannabidiolic Acid Cream differ from other treatments?

Magnesium-Cannabidiolic Acid Cream is unique because it combines magnesium with cannabidiolic acid (CBDA), which has anti-inflammatory and pain-relieving properties. Unlike many treatments that are taken orally, this cream is applied directly to the skin, potentially offering localized relief with fewer systemic side effects. ^{1 2 7 9 10}

Research Team

Simon Lee, MD

Principal Investigator

Midwest Orthopaedics at Rush

Eligibility Criteria

Inclusion Criteria

Age > 18 years

The patient provides informed consent

You have recently been diagnosed with hallux rigidus or hallux valgus.

Exclusion Criteria

You have had surgery on your big toe for hallux valgus or hallux rigidus in the past.

You are allergic to CBD, CBDa or any other ingredient in the cream.

You are pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either topical CBD cream or placebo cream for the treatment of pain secondary to hallux valgus and hallux rigidus

4 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Magnesium-Cannabidiolic Acid Cream
• Placebo Cream

Participant Groups

Group I: Mg-CBDa cream Active Control 1 Intervention

Subjects in this group will receive the active Mg-CBDa (magnesium-cannabidiolic acid) for topical treatment of hallux valgus or hallux rigidus.

Group II: Placebo cream Placebo Group 1 Intervention

Subjects in this group will receive the inactive CBD cream for topical treatment of hallux valgus or hallux rigidus. The ingredients of the placebo cream are: butyrospermum parkii (shea butter), caprylic/capric triglycerides medium-chain triglycerides (MCT oil), and food coloring to match the CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Mid-America Orthopaedic Association (MAOA)

Collaborator

Trials

1

Recruited

10+

Mid-America Orthopaedic Association

Collaborator

Trials

1

Recruited

10+

Findings from Research

In a study involving 32 dogs with canine atopic dermatitis, treatment with a mix of CBD and CBDA significantly reduced pruritus (itchiness) scores at 14 and 28 days, indicating its potential effectiveness in alleviating itching associated with the condition.

However, there was no significant improvement in the overall severity of skin lesions as measured by the CADESI-04 score, suggesting that while CBD/CBDA may help with itching, it does not address the skin lesions themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a mixed cannabidiol and cannabidiolic acid based oil on client-owned dogs with atopic dermatitis. Loewinger, M., Wakshlag, JJ., Bowden, D., et al.[2022]

A survey of 127 CBG-predominant cannabis users revealed that most use it for medical purposes, particularly for treating anxiety, chronic pain, depression, and insomnia, with many reporting significant improvements in their conditions.

The study found a favorable safety profile for CBG, with 44% of users reporting no adverse effects and only a small percentage experiencing mild symptoms, suggesting that CBG-predominant cannabis may be a viable alternative to conventional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of Patients Employing Cannabigerol-Predominant Cannabis Preparations: Perceived Medical Effects, Adverse Events, and Withdrawal Symptoms. Russo, EB., Cuttler, C., Cooper, ZD., et al.[2023]

Topical application of a 1% CBD-cream significantly reduced the clinical symptoms of autoimmune encephalomyelitis (EAE) in mice, improving hind limb paralysis and decreasing disease severity compared to untreated EAE mice.

The CBD-cream treatment also showed neuroprotective effects by reducing inflammation markers and T cell activation in the spinal cord and spleen, suggesting its potential as a therapeutic option for managing multiple sclerosis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new formulation of cannabidiol in cream shows therapeutic effects in a mouse model of experimental autoimmune encephalomyelitis. Giacoppo, S., Galuppo, M., Pollastro, F., et al.[2018]

A systematic review of 12 clinical trials involving 803 participants found that cannabidiol (CBD) is associated with a higher likelihood of withdrawal due to adverse effects compared to placebo, particularly in studies related to childhood epilepsy.

While CBD generally appears well tolerated, significant adverse effects such as abnormal liver function tests and sedation were noted, especially in combination with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. Chesney, E., Oliver, D., Green, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of a mixed cannabidiol and cannabidiolic acid based oil on client-owned dogs with atopic dermatitis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Survey of Patients Employing Cannabigerol-Predominant Cannabis Preparations: Perceived Medical Effects, Adverse Events, and Withdrawal Symptoms. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Self-initiated use of topical cannabidiol oil for epidermolysis bullosa. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A new formulation of cannabidiol in cream shows therapeutic effects in a mouse model of experimental autoimmune encephalomyelitis. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, repeated-dose pilot study of the safety, tolerability, and preliminary effects of a cannabidiol (CBD)- and cannabigerol (CBG)-based beverage powder to support recovery from delayed onset muscle soreness (DOMS). [2023]

6. England pubmed.ncbi.nlm.nih.gov

Reproductive and developmental toxicity evaluation of cannabidiol. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Cannabis: are there any benefits? [2021]

8. England pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Human skin permeation of Delta8-tetrahydrocannabinol, cannabidiol and cannabinol. [2014]

10. Netherlands pubmed.ncbi.nlm.nih.gov

(+)-Cannabidiol analogues which bind cannabinoid receptors but exert peripheral activity only. [2013]