Clinical trials: Epidermolysis Bullosa
Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa
A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
This is a Phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB.
- Conditions
- Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
- Trial name
- STEP (NCT06594393)
- Testing
- TCP-25 gel
- Where
- 13 sites in United States, France and 5 more
- Volunteers
- 32 people
- Sponsor
- Xinnate AB
Epidermolysis Bullosa
ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0) cream in the treatment of skin lesions in participants with Epidermolysis Bullosa.
- Trial name
- NCT02384460
- Testing
- SD-101-6.0 cream
- Where
- 38 sites in United States, Australia and 11 more
- Volunteers
- 169 people
- Sponsor
- Scioderm, Inc.
Epidermolysis Bullosa, Epidermolysis Bullosa Simplex
Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
The primary objective of this study is to evaluate the long term safety and tolerability of diacerein 1% ointment for 2 treatment cycles in subjects with EBS that previously participated in the CCP-020-301 or the CCP-020-101…
- Trial name
- NCT03389308
- Testing
- diacerein 1% ointment
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Castle Creek Pharmaceuticals, LLC
Dystrophic Epidermolysis Bullosa
Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa
After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which…
- Trial name
- NCT05157958
- Testing
- ALLO-ASC-SHEET, Vehicle Control
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Anterogen Co., Ltd.
Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa Dystrophica, Recessive
A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB)
This study is a non-interventional, observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB).
- Conditions
- Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa Dystrophica, Recessive, Epidermolysis Bullosa Dystrophica Dominans
- Trial name
- NCT06563414
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Krystal Biotech, Inc.
Epidermolysis Bullosa (EB), Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds
The Master Protocol includes 3 studies (Study A, Study B, and Study C) that will evaluate pz-cel and related processes in the post-marketing setting.
- Conditions
- Epidermolysis Bullosa (EB), Recessive Dystrophic Epidermolysis Bullosa (RDEB), Dystrophic Epidermolysis Bullosa (DEB)
- Trial name
- NCT07717736
- Testing
- Non-conforming pz-cel surgical application to RDEB wounds, Additional biopsies, Pz-cel surgical application to DEB wounds
- Volunteers
- 100 people
- Sponsor
- Abeona Therapeutics, Inc
Epidermolysis Bullosa Dystrophica, Recessive
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
The purpose of this study is to evaluate the safety of FCX-007, evaluate Type VII collagen (COL7) expression and the presence of anchoring fibrils and to analyze wound healing as a result of FCX-007 administration in subjects…
- Trial name
- NCT02810951
- Testing
- FCX-007
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Castle Creek Biosciences, LLC.
Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa
The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
This study is a non-interventional, observational study that will evaluate the natural history of wounds in patients with Dystrophic Epidermolysis Bullosa (DEB) for inclusion into the Krystal Biotech Phase III protocol of B-VEC…
- Trial name
- NCT04214002
- Where
- United States
- Sponsor
- Krystal Biotech, Inc.
Dystrophic Epidermolysis Bullosa
Evaluation of D-Fi for the Treatment of Wounds Due to DEB
The purpose of this study is to determine whether administration of D-Fi in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Dystrophic…
- Trial name
- NCT06892639
- Testing
- D-Fi
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Castle Creek Biosciences, LLC.
Dystrophic Epidermolysis Bullosa
Short Term Observational Study in DEB Patients
The purpose of this study is to better understand disease extent and to identify appropriate methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and qualitative manner.
- Trial name
- NCT02178969
- Where
- 10 sites in United States, Australia and 5 more
- Volunteers
- 29 people
- Sponsor
- Shire
Epidermolysis Bullosa
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)
The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo.
- Trial name
- NCT05838092
- Testing
- allo-APZ2-OTS
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- RHEACELL GmbH & Co. KG
Epidermolysis Bullosa
Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
The purpose of this study was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).
- Trial name
- NCT02014376
- Testing
- SD-101 dermal cream (3%), SD-101 Dermal Cream (6%), Vehicle (SD-101 0%)
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Scioderm, Inc.
Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa
A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients
To evaluate and further characterize the safety of EB-101 (LZRSE-Col7A1 gene-corrected keratinocyte sheets with type VII collagen [C7] expression) for the treatment of large, chronic DEB wounds in new and previously EB-101…
- Conditions
- Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, RDEB
- Trial name
- NCT05725018
- Testing
- EB-101 Surgical application of RDEB wounds
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Abeona Therapeutics, Inc
Epidermolysis Bullosa Simplex
Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex
TolaSure is a topical gel for the promotion of accelerated wound healing. This Phase I study will assess the safety, tolerability, and clinical effects of TolaSure when applied to wounded skin areas of patients diagnosed with…
- Trial name
- TAMES (NCT05062070)
- Testing
- TolaSure Topical Gel, Vehicle Topical Gel
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- BioMendics, LLC
RDEB
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
- Trial name
- NCT05708677
- Testing
- EB-101
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Abeona Therapeutics, Inc
Recessive Dystrophic Epidermolysis Bullosa
A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting
The goal of this observational study is to evaluate the long-term safety and wound healing durability (up to 15 years) for participants with Recessive Dystrophic Epidermolysis Bullosa (RDEB) who were treated with pz-cel.
- Trial name
- NCT07700966
- Testing
- Prademagene Zamikeracel
- Where
- 4 sites in United States
- Volunteers
- 250 people
- Sponsor
- Abeona Therapeutics, Inc
Junctional Epidermolysis Bullosa, Dystrophic Epidermolysis Bullosa
Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa
The objective of this study is to compare the efficacy and safety of RGN-137 topical gel with that of placebo gel for treatment of junctional epidermolysis bullosa (JEB) or dystrophic epidermolysis bullosa (DEB).
- Trial name
- CELEB (NCT03578029)
- Testing
- RGN-137
- Where
- 5 sites in United States
- Volunteers
- 4 people
- Sponsor
- Lenus Therapeutics, LLC
Dystrophic Epidermolysis Bullosa
Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.
- Trial name
- NCT02579369
- Testing
- Allogeneic mesenchymal stem cells, Polyurethene Film
- Where
- South Korea
- Volunteers
- 2 people
- Sponsor
- Anterogen Co., Ltd.
Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa
Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa
This trial will create a skin graft, which the investigators call "LEAES," using the patient's own skin cells that have been genetically engineered in the lab to express a missing protein called type VII collagen.
- Trial name
- NCT01263379
- Testing
- LZRSE-Col7A1 Engineered Autologous Epidermal Sheets
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Abeona Therapeutics, Inc
Inherited Epidermolysis Bullosa
A Double-blind, Intra-individual Comparison, POC Trial of AC-203 in EB Patients
Inherited epidermolysis bullosa (EB) is a genetic skin disorder characterized by skin fragility and recurrent blister formation.
- Trial name
- NCT03468322
- Testing
- AC-203, Vehicle
- Where
- 2 sites in Taiwan
- Volunteers
- 9 people
- Sponsor
- TWi Biotechnology, Inc.