None listed
Conditions
Brief summary
This study will assess whether topical application of a CBD gel can provide analgesia for patients suffering from osteoarthritis of the hand. A growing body of evidence suggests that inflamed tissue caused by osteoarthritis may be susceptible to treatment using CBD. Despite oral ingestion of cannabinoid products being the preferred route of administration, its poor aqueous solubility and extensive first-pass metabolism lead to poor bioavailability, which limits see its potential efficacy. The ability to deliver CBD directly to local, inflamed tissue using topical application may provide superior analgesia than oral dosage forms, whilst minimising any concerns related to systemic exposure. This study will assess whether topical application of a CBD gel can provide analgesia for patients suffering from osteoarthritis of the hand. In addition to analgesia, the study will investigate whether topical CBD can provide benefits for other symptoms of osteoarthritis of the hand; poor grip strength and hand functionality. Results from this study will support further clinical development of the CBD gel, as well as future prescribing to patients.
Interventions
The treatment product is a topical 4% w/w Cannabidiol gel that is applied 3 times per day over a four week period to joints of the hand suffering painful arthritis. The product is supplied in a metered pump that administers 0.25 ml. Subjects will be instructed to apply a single 0.25 ml pump to the affected hand at each application. The gel will then be massaged into the joints of the hand affected by arthritis.
Subjects will complete a questionnaire each night via their smart-phone, that wil
The treatment product is a topical 4% w/w Cannabidiol gel that is applied 3 times per day over a four week period to joints of the hand suffering painful arthritis. The product is supplied in a metered pump that administers 0.25 ml. Subjects will be instructed to apply a single 0.25 ml pump to the affected hand at each application. The gel will then be massaged into the joints of the hand affected by arthritis. Subjects will complete a questionnaire each night via their smart-phone, that will ask them to confirm that they have adhered to the application instructions that day as described by the protocol.
Sponsors
Avecho Biotechnology
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Males and females with symptomatic hand OA affecting the fingers and thumb. - At least 3 joints affected by distal interphalangeal (DIP) nodal hand OA, defined by Heberden's Nodes on physical exam. - At least one DIP nodal hand OA with: -Sufficiently severe frequent pain, as categorized by a minimum NPRS pain severity of 3 on a 0 - 10 scale. -Frequent pain: pain on most days of the month for at least one month in the last year. - Access to the internet and a smart phone, and the ability to use an app. - Able to understand and sign the Informed Consent Form. - Willing to follow the protocol requirements and comply with protocol restrictions.
Exclusion criteria
- History or current inflammatory arthritis (examples: gout, psoriatic arthritis, and rheumatoid arthritis). - Medications and/or medical conditions that are likely to change over the 6-week trial period. - Prior surgery on the DIP joints. - Pregnancy or lactation. - Dermatology conditions of the hand. - Regular self-reported use of cannabis, or cannabis-based products during the past three months. - Known allergies or hypersensitivity to cannabis-based products or any of the excipients in the study drug.
Outcome results
None listed