Topical cannabis‐based medicines – A novel paradigm and treatment for non‐uremic calciphylaxis leg ulcers: An open label trial

Abstract

Non‐Uremic Calciphylaxis (NUC) is a rare condition that often manifests as intractable and painful integumentary wounds, afflicting patients with a high burden of co‐morbidity. The Endocannabinoid System (ECS) is a ubiquitous signalling system that is theorised to be dysregulated within wound beds and associated peri‐wound tissues. Preclinical research has shown that the dominant chemical classes derived from the cannabis plant, cannabinoids, terpenes, and flavonoids, interact with the integumentary ECS to promote wound closure and analgesia. This is a prospective open label cohort study involving two elderly Caucasian females with recalcitrant NUC leg ulcers of greater than 6 months duration. Topical Cannabis‐Based Medicines (TCBM) composed of cannabinoids, terpenes, and flavonoids were applied daily to both the wound bed and peri‐wound tissues until complete wound closure was achieved. Wounds were photographed regularly, and the digital images were subjected to planimetric analysis to objectively quantify the degree of granulation and epithelization. Analgesic utilisation, as a surrogate/proxy for pain scores, was also tracked. The cohort had a mean M3 multimorbidity index score of 3.31. Complete wound closure was achieved in a mean of 76.3 days. Additionally, no analgesics were required after a mean of 63 days. The treatments were well tolerated with no adverse reactions. The positive results demonstrated in very challenging wounds such as NUC, among highly complex patients, suggest that TCBM may have an even broader role within integumentary and wound management. This treatment paradigm warrants being trialled in other wound types and classes, and ultimately should be subjected to randomised controlled trials.

A new treatment paradigm for sickle cell disease leg ulcers: Topical cannabis‐based medicines

“…It has been theorized that dysregulated ECS signalling is central to the pathophysiology of integumentary and wound conditions 4,5 . Together with a robust preclinical literature that reports the ability of cannabis extracts to promote wound healing and analgesia, human evidence is beginning to accrue demonstrating that cannabis‐based medicines containing cannabinoids, terpenes and flavonoids are showing promise in the most challenging and “orphaned” diseases such as epidermolysis bullosa, 6 pyoderma gangrenosum 7 and calciphylaxis, both uraemic and non‐uraemic 8,9 …”

The therapeutic potential of cannabinoids for integumentary wound management

“…Topical CBD has already been used safely in two small case series of orphaned diseases (Epidermolysis Bullosa [EB] and Pyoderma Gangrenosum) wherein patients reported decreased pain and, for the EB group, subjective decreases in healing time 79,80 . A topical CB formulation containing CBD, THC and various terpenes and flavonoids has also been successfully used in a small cohort of two patients with biopsy proven‐calciphylaxis; clinically significant analgesia and closure were achieved in 0.6 and 2.5 months, respectively 81 . These few studies suggest that CBs hold great promise for the treatment of classically difficult or recalcitrant wound subtypes.…”

“Less pain with more gain”—Managing wound‐related pain with cannabis‐based medicines

“…Additionally, three cases of pyoderma gangrenosum experienced rapid pain relief together with opioid sparing while using topical cannabis oil containing both THC and CBD 25 . A cohort of patients with nonuremic calciphylaxis leg wounds, from a clinical trial using a topically applied proprietary CBM containing cannabinoids, terpenes, and flavonoids, demonstrated complete wound closure within 2.5 months and zero utilization of all analgesics at 2.1 months 26 . A cohort of children with Epidermolysis Bullosa experienced relief of WRP, opioid sparing, and a degree of wound healing in an open label trial involving topical CBD 27 …”