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• Status: Withdrawn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: 0
• Participant gender: All

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)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elena Pope
• Collaborator: Avicanna Inc
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:(phase 2) Patients 4-50 years of age

• Diagnosis of RDEB (clinically and/or molecular diagnosis)-

• Wounds that have not been healing for over 4 weeks

• Signed consent/assent form Inclusion criteria -Phase 3

• Patients 4-50 years of age

• Diagnosis of EB (clinically and/or molecular diagnosis)

• Evidence of either acute or chronic wounds on both extremities

• Patients enrolled in phase II are also eligible for participation in this phase, if they meet the current criteria and are interested in participation * Signed consent/assent form

Exclusion Criteria:

• Previous known allergy or intolerance to CBD cream

• Topical and systemic use of cannabinoids in the past 2 weeks

• Topical use of antibiotics, corticosteroids for the past 2 weeks

• Other systemic medications that will interfere with the wound healing (corticosteroids, immunosuppressives, antibiotics) in the past 4 weeks

• Surgery of the selected area in the past 8 weeks

• Patients received medications metabolized via CYP3A4 enzyme (ketoconazole, itraconazole, ritonavir, clarithromycin, phenobarbital, rifampicin, carbamazepine, hexobarbital) for the past 2 weeks

• Pregnancy