Cannabis-based Ointment: Clinical Trial for Skin Diseases

As the cannabis industry continues to expand, medical cannabis patients have a wider arsenal of products and formulations at their disposal to help treat a multitude of conditions. But where the product development and technology has advanced, the science has lagged behind–and not for lack of interest but largely from restrictions in research funding due to the legal status of the plant.

While several pre-clinical studies have shown that topical cannabis formulations can be effective in treating contact dermatitis and arthritis, there is limited evidence in humans, other than case reports and small studies, despite the fact that patients with skin conditions routinely use these products.[1, 2, 3, 4] Luckily, one medical cannabis company is trying to change that.

One World Cannabis (OWC) Pharmaceutical Research Corp is studying a line of cannabinoid-based therapies, including sublingual tablets and topical creams, across a variety of conditions, such as multiple myeloma, psoriasis, fibromyalgia, migraine, and post-traumatic stress disorder.

OWC conducted a Phase I clinical trial that evaluated the safety and tolerability of their topical formulation to treat skin diseases. In fact, this was the first trial to ever evaluate cannabis for clinical topical use.

The OWC ointment is a 1:1 formulation with an equal balance of cannabidiol (CBD) and tetrahydrocannabinol (THC) (30 mg each). This trial first looked at the effects of applying the cannabis-based ointment to the skin across 24 hours in a small group of 26 healthy individuals. Researchers then evaluated the effects of multiple applications of the cannabis-based ointment over a six-week period on one arm compared to a placebo (non-active substance) on the other arm.

Investigators in the trial evaluated safety and tolerability using a few different methods. In addition to monitoring changes on the surface of the skin, they also checked physiological properties like blood pressure and heart rate, to make sure that the ointment was not causing any fluctuations in key biological processes.

Results of the trial were positive–the cannabis-based ointment was well tolerated, with no serious safety events reported, other than minor irritation in one individual. Based on the outcomes this study, OWC will be advancing the ointment forward into testing.

“We are encouraged by the positive results from this Phase 1 safety trials,” said Mordechai Bignitz, chief executive officer of OWC, in a press release. “We plan to commence a Phase 2 trial with [medical grade cannabis] ointment for the treatment of psoriasis.”

Image Credit: Christin Hume

Image Source: https://unsplash.com/photos/0MoF-Fe0w0A

References

  1. Gaffal E, et al. Anti-inflammatory activity of topical THC in DNFB-mediated mouse allergic contact dermatitis independent of CB1 and CB2 Allergy. 2013;68:994-1000.
  2. Hammell DC, et al. Transdermal cannabidiol reduces inflammation and pain-related behaviours in a rat model of arthritis. Eur J Pain. 2016;20:936-948.
  3. Maida V & Corban J. Topical medical cannabis: A new treatment for wound pain-three cases of pyoderma gangrenosum. J Pain Symptom Manage. 2017;54:732-736.
  4. Mounessa JS, et al. The role of cannabinoids in dermatology. J Am Acad Dermatol. 2017;77(1):188-190.

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