Epidermolysis Bullosa Dystrophica Clinical Trial
Official title:
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).
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01263379 -
Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa
|
Phase 1/Phase 2 | |
Completed |
NCT01716169 -
Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
|
N/A | |
Completed |
NCT00951964 -
Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)
|
Phase 2 | |
Recruiting |
NCT03269474 -
Computational Drug Repurposing for All EBS Cases
|
||
Recruiting |
NCT01019148 -
Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa
|
||
Completed |
NCT03241628 -
Proof of Concept Study for a Dressing Glove
|
N/A | |
Not yet recruiting |
NCT05390073 -
Growth Hormone in EB
|
||
Recruiting |
NCT04213703 -
A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
|
||
Not yet recruiting |
NCT06177353 -
Study of the Blood and Skin Immunological Profile of Patients With Recessive Dystrophic Epidermolysis Bullosa: in Vivo Analysis and the Impact of Placental Stem Cells in Vitro
|
||
Recruiting |
NCT06007235 -
CACIPLIQ20 in Wound Healing in Subjects With Epidermolysis Bullosa
|
N/A | |
Active, not recruiting |
NCT05843994 -
Artificial Intelligence Patient App for RDEB SCCs
|
||
Active, not recruiting |
NCT05033574 -
The State of Sexual Development in Children With Inherited Epidermolysis Bullosa
|
||
Terminated |
NCT00587223 -
Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)
|
Phase 3 | |
Active, not recruiting |
NCT04171661 -
Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa
|
Early Phase 1 | |
Terminated |
NCT00533572 -
Recessive Dystrophic Epidermolysis Bullosa Screening for Possible Gene Transfer
|
N/A | |
Completed |
NCT00904163 -
Characteristics of Adult Patients With Recessive Dystrophic Epidermolysis Bullosa
|
N/A | |
Recruiting |
NCT03786237 -
Rigosertib for RDEB-SCC
|
Phase 1/Phase 2 |