Epidermolysis Bullosa Clinical Trial
OBJECTIVES: I. Develop a large roster of well-characterized patients with various forms of
inherited and acquired epidermolysis bullosa (EB).
II. Generate a large data bank of clinical, historical, and genetic information concerning
these patients.
III. Accumulate donated tissue specimens, including selected cells and DNA, from selected
patient subsets for the establishment of permanent tissue cell banks.
IV. Promote and facilitate research in EB.
PROTOCOL OUTLINE: Patients are enrolled by mail or clinic visit at 1 of 4 clinical centers.
Clinical, epidemiological, and laboratory data are collected.
Medical and family histories are obtained in a detailed interview in person, by phone, or by
mail. Diagnostic studies to confirm the type of epidermolysis bullosa are performed as
indicated. A pedigree chart is completed on the first affected family member entered.
Selected patients are followed at least biannually. A study duration of approximately 10
years is anticipated.
;
Observational Model: Natural History, Time Perspective: Longitudinal
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00380640 -
The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa
|
Phase 2 | |
| 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 | |
| Withdrawn |
NCT01454687 -
Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes
|
N/A | |
| Completed |
NCT00014729 -
Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa
|
Phase 1 | |
| Recruiting |
NCT05838092 -
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)
|
Phase 3 | |
| Recruiting |
NCT03269474 -
Computational Drug Repurposing for All EBS Cases
|
||
| Completed |
NCT03068780 -
Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa
|
Phase 3 | |
| Terminated |
NCT02090283 -
Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
|
Phase 2 | |
| Completed |
NCT02582775 -
MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs
|
Phase 2 | |
| Recruiting |
NCT04213703 -
A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
|
||
| Completed |
NCT02384460 -
ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
|
Phase 3 | |
| Terminated |
NCT02670330 -
Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa
|
Phase 3 | |
| Terminated |
NCT01619670 -
A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa
|
Phase 4 | |
| Recruiting |
NCT01340235 -
Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin
|
Phase 3 | |
| Completed |
NCT02014376 -
Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
|
Phase 2 | |
| Completed |
NCT04217538 -
Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa
|
||
| Completed |
NCT03942250 -
Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
|
N/A | |
| Completed |
NCT01033552 -
Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs
|
Phase 1/Phase 2 | |
| Completed |
NCT04227106 -
Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
|
Phase 3 |