Epidermolysis Bullosa Clinical Trial
Official title:
An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of Zorblisaâ„¢ (SD-101-6.0) in Patients With Epidermolysis Bullosa
The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).
This was an open label, multi-center extension study to assess the long-term safety of
topically applied SD-101-6.0 in participants with simplex, recessive dystrophic, and
junctional non-Herlitz EB. SD-101-6.0 was applied topically once a day to the entire body.
The planned duration of treatment with SD-101-6.0 for Study SD-006 was up to 48 months, with
a safety follow-up period of 30 days; however, the study was terminated early by the sponsor.
The maximum study duration completed by at least 1 participant, treatment and safety
follow-up, was 37 months.
Participants who successfully completed Study SD-005 had the option to rollover into Study
SD-006. The screening/baseline visit (Visit 1) occurred at Visit 5 (approximately 90 days
from baseline) of Study SD-005. The Body Surface Area (BSA) assessments of lesional skin and
wound burden performed at Visit 5 (approximately 90 days from baseline) for Study SD-005 were
utilized as the baseline assessments for Study SD-006. Participants returned for follow-up
visits at Month 1 then every 3 months.
At each visit, assessments included BSA of lesional skin and wound burden. For target wounds
that are not closed by the end of Study SD-005, the ARANZ picture and calculation of target
wound area at the final visit for Study SD-005 was used as the baseline area size of the
target wound for Study SD-006. These unhealed target wounds from Study SD-005 were assessed
via ARANZ SilhouetteStarâ„¢ at each subsequent scheduled visit until the target wound was
documented as closed. Closed wounds were assessed for scarring.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00380640 -
The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa
|
Phase 2 | |
Completed |
NCT00004761 -
Establishment of the National Epidermolysis Bullosa Registry
|
N/A | |
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Withdrawn |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 |
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 |