The Efficacy and Safety of 3% Cannabidiol (CBD) Cream in Patients With Epidermolysis Bullosa: A Phase II/III Trial
Status:
Withdrawn
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
Epidermolysis bullosa (EB) is rare, devastating, and currently incurable genetic blistering
disorders characterized by fragility of skin and mucosal membranes. Therapeutic options for
EB are limited. Acute and chronic wounds cause pain, itching and infection, altering quality
of life and impair wound healing. In absence of a cure, wound care is paramount to alleviate
suffering.
Anecdotal experience suggest that CBD application alleviates the pain and itching and
improves wound healing by controlling the inflammatory process. We propose to undertake a
phase II/III study exploring the safety, tolerability and efficacy of topical application of
3% Cannabidiol cream (CBD) on acute and chronic wounds affecting patients with EB.
We are doing this trial to determine safety and tolerability of topical CBD cream in a cohort
of RDEB patients with chronic wounds (phase II trial), and to evaluate the efficacy and
safety of CBD cream in EB with acute and chronic wounds in promoting wound healing, decrease
blister formation, pain, itching and improve overall quality of life (phase III trial)