NCT04908215

INM-755 (Cannabinol) Cream for Treatment of Epidermolysis Bullosa

A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (Cannabinol) Cream in Patients With Epidermolysis Bullosa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: InMed Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of INM-755 (cannabinol) cream and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with epidermolysis bullosa (EB).

Detailed description

This is an international, multicenter study to evaluate the safety and obtain preliminary evidence of efficacy of topically applied INM-755 (cannabinol) cream in up to 20 patients with inherited EB (Simplex, Dystrophic, Junctional, or Kindler). The study uses a within-patient, double-blind design in which matched index areas are randomized to INM-755 (cannabinol) cream or vehicle cream as a control. Selected index areas may be wounds or non-wound areas. Randomized treatments are applied daily to non-wound areas and every 1, 2, or 3 days on wounds, according to the patient's schedule for dressing changes. Treatment is over a 28-day period. EB symptoms are evaluated based on patient-reported outcomes. Wound healing is measured by digital photography. In this study designed to obtain preliminary evidence of efficacy, there is no single primary efficacy endpoint. Efficacy endpoints vary according to the presenting symptoms in each patient, which may include the presence of open wounds, wound pain associated with dressing changes, background wound pain (not procedurally linked), wound itch, and itch in non-wound areas. Net benefit from INM-755 cream is evaluated within each patient and based on their clinical needs at baseline. Enrollment is beginning with adults and may be expanded to include adolescents.

Conditions

• Epidermolysis Bullosa Simplex
• Epidermolysis Bullosa, Junctional
• Epidermolysis Bullosa Dystrophica
• Kindler Syndrome

Interventions

Type	Name	Description
DRUG	INM-755 (cannabinol) cream	topical cream containing cannabinol for dermal application
DRUG	Vehicle Cream	topical cream base for dermal application containing no active agent

Timeline

• Start date: 2021-12-28
• Primary completion: 2023-04-03
• Completion: 2023-04-19
• First posted: 2021-06-01
• Last updated: 2023-07-03

Locations

7 sites across 5 countries: France, Germany, Greece, Israel, Italy