A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (Cannabinol) Cream in Patients With Epidermolysis Bullosa
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).
• Male or female patients aged ≥18 years with documented diagnosis of any of the following types of inherited EB: Simplex, Junctional, Dystrophic, Kindler. Enrolment will be extended to patients ≥12 years old and \<18 years old after positive opinion of a data monitoring committee after at least 4 adult patients have completed study.
• Presence of at least 1 pair of well-matched index areas. Up to 2 pairs of index areas (1 pair of non-wound and 1 pair of wound index areas) can be selected in each patient
• For non-wound itch index areas, both areas should:
‣ Have chronic itch with a score ≥40 mm on a 100 mm VAS
⁃ Not exceed 20 percent of body surface area (BSA) or be less than 1 percent of BSA
⁃ Be similar size, up to twice the area of the smaller index area
• For wound index areas, both wounds should:
‣ Have a surface area ≥5 cm\^2 and ≤50 cm\^2 inclusive and be aged ≥3 weeks
⁃ Be well matched for size (up to twice the area of the smaller index area) and age (both either ≥3 weeks to 3 months or \>3 months)
• Female patients of childbearing potential or men whose sexual partners are women of childbearing potential (WOCBP) must use highly effective birth control
• WOCBP must have a negative urine pregnancy test result at baseline
• Must provide written consent (or assent for patients aged \<18 years with parental/guardian consent)