7 completed, 6 active not recruiting, 3 recruiting, 3 terminated. 23 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 23 | Completed 7, Active not recruiting 6, Recruiting 3, Terminated 3, Unknown 2, Not yet recruiting 1, Withdrawn 1 |
| Phase 2 | 3 | Active not recruiting 1, Completed 1, Withdrawn 1 |
Follow Epidermolysis Bullosa: new trials by email Literature Review of Epidermolysis Bullosa trials Research Report on Epidermolysis Bullosa
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa SD-101 Dermal Cream (6%) - Epidermolysis Bullosa (EB) | Phase 3 | Not yet recruiting | Paradigm Therapeutics | 80 | 2026-11-15 | 2026-09-09 |
| Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa SD-101 Dermal Cream (6%), Vehicle (SD-101 0%) - Epidermolysis Bullosa (EB) | Phase 3 | Recruiting | Paradigm Therapeutics | 80 | 2026-07-21 | 2026-10-15 |
| A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa KB803, Placebo - Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa | Phase 3 | Recruiting | Krystal Biotech, Inc. | 16 | 2025-06-20 | 2026-03-12 |
| A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa Oleogel-S10 - Epidermolysis Bullosa, Junctional Epidermolysis Bullosa | Phase 3 | Recruiting | Chiesi Farmaceutici S.p.A. | 6 | 2025-04-18 | 2025-12-22 |
| Evaluation of D-Fi for the Treatment of Wounds Due to DEB D-Fi - Dystrophic Epidermolysis Bullosa | Phase 3 | Active not recruiting | Castle Creek Biosciences, LLC. | 32 | 2025-03-27 | 2026-03-13 |
| An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS) AC-203, Vehicle - Generalized Epidermolysis Bullosa Simplex | Phase 2 / Phase 3 | Active not recruiting | TWi Biotechnology, Inc. | 80 | 2024-04-04 | 2026-07-09 |
| Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III) allo-APZ2-OTS, Placebo - Epidermolysis Bullosa | Phase 3 | Active not recruiting | RHEACELL GmbH & Co. KG | 9 | 2023-10-18 | 2025-12-10 |
| Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over) allo-APZ2-OTS, Placebo - Epidermolysis Bullosa | Phase 3 | Active not recruiting | RHEACELL GmbH & Co. KG | 91 | 2023-06-13 | 2025-12-10 |
| A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients EB-101 Surgical application of RDEB wounds - Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa | Phase 3 | Active not recruiting | Abeona Therapeutics, Inc | 12 | 2023-04-02 | 2025-06-27 |
| A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa Open Label Topical Beremagene Geperpavec (B-VEC) - Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa | Phase 3 | Completed | Krystal Biotech, Inc. | 47 | 2021-05-25 | 2024-04-09 |
| Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB Topical Beremagene Geperpavec, Placebo - Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa | Phase 3 | Completed | Krystal Biotech, Inc. | 31 | 2020-08-17 | 2023-02-17 |
| The Efficacy and Safety of 3% Cannabidiol (CBD) Cream in Patients With Epidermolysis Bullosa: A Phase II/III Trial AVCN583601 (3% Cannabidiol cream) - Epidermolysis Bullosa, Pain | Phase 2 / Phase 3 | Withdrawn | Elena Pope | 2020-08-01 | 2021-06-18 | |
| A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa FCX-007 (dabocemagene autoficel; see below for FCX-007 description) - Recessive Dystrophic Epidermolysis Bullosa | Phase 3 | Active not recruiting | Castle Creek Biosciences, LLC. | 6 | 2020-06-09 | 2026-03-18 |
| Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) EB-101 - Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa | Phase 3 | Completed | Abeona Therapeutics, Inc | 11 | 2020-01-10 | 2022-12-05 |
| Pregabalin Treatment for RDEB Pain and Itch Pregabalin - Pain, Neuropathic, Itch | Phase 3 | Completed | The Hospital for Sick Children | 1 | 2019-08-07 | 2025-01-22 |
| Injections of Botulinic Toxin in Plantar Lesions of Localized Epidermolysis Bullosa Simplex Botulinic toxin, Placebo - Epidermolysis Bullosa Simplex | Phase 2 / Phase 3 | Completed | University Hospital, Toulouse | 18 | 2018-06-14 | 2026-09-21 |
| Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa Oleogel-S10, Control gel - Epidermolysis Bullosa | Phase 3 | Completed | Amryt Research Limited | 223 | 2017-03-29 | 2023-07-20 |
| Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa SD-101-6.0 cream - Epidermolysis Bullosa | Phase 3 | Terminated | Scioderm, Inc. | 152 | 2015-06-09 | 2019-09-27 |
| ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa SD-101-6.0 cream, Placebo (SD-101-0.0) cream - Epidermolysis Bullosa | Phase 3 | Completed | Scioderm, Inc. | 169 | 2015-03-11 | 2020-04-09 |
| A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane Amniotic Membrane - Epidermolysis Bullosa Dystrophica, Recessive, Ulcer | Phase 3 | Unknown | Assistance Publique - Hôpitaux de Paris | 22 | 2015-01-01 | 2016-11-04 |
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Epidermolysis Bullosa Dystrophica (10) · Pruritus (3) · Epidermolysis Bullosa Simplex (2) · Epidermolysis Bullosa, Junctional (2) · Blister (1) · Collagen Diseases (1) · Congenital Abnormalities (1) · Connective Tissue Diseases (1) · Corneal Injuries (1) · Genetic Diseases, Inborn (1) · Neuralgia (1) · Pain (1) · Skin Abnormalities (1) · Skin Diseases (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (23) · Skin Diseases, Genetic (23) · Skin Diseases, Vesiculobullous (23) · Skin and Connective Tissue Diseases (23) · Congenital Abnormalities (22) · Genetic Diseases, Inborn (22) · Skin Abnormalities (22) · Skin Diseases (22) · Collagen Diseases (9) · Connective Tissue Diseases (9) · Pathological Conditions, Signs and Symptoms (5) · Signs and Symptoms (3) · Skin Manifestations (3) · Nervous System Diseases (2)
Biological Dressings (1) · Drugs, Investigational (1) · Erythromycin (1) · Pregabalin (1) · abobotulinumtoxinA (1) · diacerein (1) · episalvan (1)
Krystal Biotech, Inc. (3) · Abeona Therapeutics, Inc (2) · Castle Creek Biosciences, LLC. (2) · Paradigm Therapeutics (2) · RHEACELL GmbH & Co. KG (2) · Scioderm, Inc. (2) · Amryt Research Limited (1) · Assistance Publique - Hôpitaux de Paris (1) · Centre Hospitalier Universitaire de Nice (1) · Chiesi Farmaceutici S.p.A. (1) · Elena Pope (1) · Organogenesis (1) · Shire Regenerative Medicine, Inc. (1) · TWi Biotechnology, Inc. (1) · The Hospital for Sick Children (1)
United States (15) · France (8) · Austria (6) · Spain (6) · Poland (5) · United Kingdom (5) · Australia (4) · Germany (4) · Israel (4) · Italy (4) · Canada (3) · Greece (3) · Serbia (3) · Argentina (2) · Chile (2)
Alan Arbuckle, MD, FAAD, FAAP (1) · Angela Iheanacho, MS (1) · Christine Chiaverini, PH (1) · Damien Bates, MD, PhD, FRACS (Plast.) (1) · David Chien, MD (1) · Elena Pope, MD (1) · Elizabeth Alvarez- Connelly, MD (1) · Jean Tang, MD (1) · Johannes S Kern, MD PhD (1) · Juliette Mazereeuw-Hautier, MD (1) · Sarah Abdelwahab, MD (1)
PMID 31186047, PMID 32576219, PMID 32693833, PMID 36516090, PMID 39441591, PMID 40220208, PMID 40570869, PMID 42205007
2014 (2), 2016 (1), 2017 (1)