The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing. It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
ABH001 applications topically every 4 weeks (±1 week) with protocol-specified dressings until wound healed or up to 44 weeks
Control wound care with protocol-specified dressings every 4 weeks (±1 week) up to 20 weeks with optional cross-over to ABH001 for additional 20 weeks
Phoenix Children's Hospital
Phoenix, Arizona, United States
Lucile Packard Children's Hospital at Stanford University
Redwood City, California, United States
Reduction in wound surface area
Time frame: 24 weeks
Change in wound pain and wound itch
Time frame: 24 weeks
Patient global impression of change (PGIC)
Time frame: 24 weeks
Clinician global impression of change (CGIC)
Time frame: 24 weeks
Proportion of subjects achieving reduction in wound surface area
Time frame: 24 weeks
Time to reduction of wound surface area and duration of reduction
Time frame: 24 weeks
Durability of wound healing
Time frame: 24 weeks
Incidence, relatedness and severity of adverse events
Time frame: Up to 48 Weeks
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Rady Children's Hospital - San Diego/UCSD, Pediatric and Adolescent Dermatology
San Diego, California, United States
Denver Children's Hospital
Aurora, Colorado, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, United States
Landeskrankenhaus Salzburg-Universitätsklinikum der Paracelsus Medizinischen Privatuniversität
Salzburg, Salzburg, Austria
Toronto Regional Wound Healing Clinic
Mississauga, Ontario, Canada
University of Montreal
Montreal, Quebec, Canada
Hôpital Necker-Enfants Malades
Paris, Île-de-France Region, France
...and 4 more locations