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Oral and Topical Phytocannabinoids for Psoriasis
Sponsor: Federal University of Latin American Integration
Summary
Psoriasis is a chronic inflammatory skin disease that affects approximately 2% of the global population and is frequently associated with psychiatric comorbidities such as anxiety and depression. Although conventional treatments, including topical corticosteroids and biologic agents, may be effective, many patients face challenges related to treatment adherence, adverse effects, and the psychosocial impact of the disease. This open label study aims to investigate the efficacy and acceptability of medicinal cannabis formulations administered orally and topically in the management of mild to moderate psoriasis. 37 participants will be included and will use full spectrum cannabis formulations in the (1:1:1) CBD:CBG:THC ratio at a concentration of 20 mg/ml. The protocol will have a total duration of 180 days, consisting of 60 days of isolated treatment followed by 120 days of combined treatment. Efficacy will be assessed using validated instruments, including PASI, DLQI, BDI II and BAI, the Visual Analog Scale for pruritus intensity, the Cosmetic Acceptability Scale, and the Treatment Satisfaction Scale. The use of cannabis formulations is expected to promote clinical improvement of skin lesions, reduction of subjective symptoms such as pruritus and discomfort, and a positive impact on patients quality of life. This study seeks to contribute to the generation of evidence, regarding the efficacy, safety, and acceptability of therapeutic cannabis use in the dermatological context.
Official title: Oral and Topical Use of Phytocannabinoids for Patients With Psoriasis Vulgaris: An Open-Label Prospective Study - CBDermis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2025-11-01
Completion Date
2027-02
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Oral Cannabis Extract
Oral administration of a full-spectrum cannabis extract containing CBD, CBG, and THC in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid. Dose titration will be performed progressively according to tolerability, followed by maintenance at the maximum dose.
Topical cannabis cream
Topical formulation containing CBD, CBG, and THC in a 1:1:1 ratio (20 mg/mL each), applied directly to psoriatic lesions twice daily throughout the study period. No dose titration will be performed.
Locations (1)
Federal University of Latin American Integration
Foz do Iguaçu, Paraná, Brazil