Status:
COMPLETED
INM-755 (Cannabinol) Cream for Treatment of Epidermolysis Bullosa
Lead Sponsor:
InMed Pharmaceuticals Inc.
Conditions:
Epidermolysis Bullosa Simplex
Epidermolysis Bullosa, Junctional
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 w...
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 (S...
Eligibility Criteria
Inclusion
- Key
- 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)
- Key
Exclusion
- 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
- Uncontrolled diabetes mellitus
- Chronic pruritus primarily attributable to pathologies or conditions other than EB
- Blood transfusion to treat anemia within the past 3 months
- Use of any investigational drug within 30 days or 5 half-lives (whichever is longer)
- An underlying condition which places the patient at unacceptable risk
- Women who are pregnant, breastfeeding (lactating), or planning to become pregnant during the study
Key Trial Info
Start Date :
December 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04908215
Start Date
December 28 2021
End Date
April 19 2023
Last Update
July 3 2023
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Saint Louis APHP Paris
Paris, France, 75010
2
CHU Toulouse - Hopital Larrey
Toulouse, France, 31059
3
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany, 79104
4
Andreas Syggros Hospital of Cutaneous Venereal Diseases
Athens, Greece, 16121