INTERVENTIONALCOMPLETEDNCT04908215

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).

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-07-03

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 19 (ACTUAL)
Start date: 2021-12-28
Sponsor: InMed Pharmaceuticals Inc.
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 7
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Cannabinol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

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

Eligibility

Population and criteria

Sex: ALL
Minimum age: 12 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

Inclusion criteria

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: 1. Have chronic itch with a score ≥40 mm on a 100 mm VAS 2. Not exceed 20 percent of body surface area (BSA) or be less than 1 percent of BSA 3. Be similar size, up to twice the area of the smaller index area
For wound index areas, both wounds should: 1. Have a surface area ≥5 cm\^2 and ≤50 cm\^2 inclusive and be aged ≥3 weeks 2. 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)

Exclusion criteria

EB index areas have evidence of infection
Patient has a systemic infection or used systemic antibiotics for EB-related infections within 7 days
Use of systemic corticosteroids within 30 days or of topical corticosteroids on chosen index areas within 14 days
Immunosuppressive therapy or cytotoxic chemotherapy within 60 days
Use of any high potency opioid within 30 days
Use of cannabis, cannabis extracts, or any cannabinoid products for medical or recreational use by any route of administration within 2 weeks
Prior stem cell transplant or gene therapy for EB
History of malignancy including basal cell and squamous cell carcinomas
Arterial or venous disorder resulting in ulcerated wounds

primary outcomes