Clinical trials: Epidermolysis Bullosa (EB)
Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Dystrophica
Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)
The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with dystrophic or junctional epidermolysis bullosa.
- Trial name
- NCT00587223
- Testing
- Apligraf, Standard dressing regimen
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- Organogenesis
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
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
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over)
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
- NCT05464381
- Testing
- allo-APZ2-OTS
- Where
- 16 sites in Argentina, Austria and 10 more
- Volunteers
- 91 people
- Sponsor
- RHEACELL GmbH & Co. KG
Epidermolysis Bullosa (EB), Junctional Epidermolysis Bullosa
A Study to Evaluate ENERGI-F703EB Cream in Epidermolysis Bullosa
This is a phase II, intra-subject randomized, double-blind, vehicle-controlled, parallel, multicenter study to evaluate the safety and preliminary efficacy of ENERGI-F703EB Cream in subjects who are ≥ 18 years old with…
- Conditions
- Epidermolysis Bullosa (EB), Junctional Epidermolysis Bullosa, Epidermolysis Bullosa Simplex, Dystrophic Epidermolysis Bullosa
- Trial name
- NCT07858422
- Testing
- ENERGI-F703EB Cream, Matched vehicle cream
- Where
- Taiwan
- Volunteers
- 24 people
- Sponsor
- Energenesis Biomedical Co., Ltd.
Epidermolysis Bullosa (EB)
Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
The upcoming trial is for EB patients is a topically applied whole-body treatment of patients with either Simplex, RDEB or Junctional (nH) ages 1 month to 12 years old at study entry.
- Trial name
- NCT07482787
- Testing
- SD-101 Dermal Cream (6%), Vehicle (SD-101 0%)
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Paradigm Therapeutics
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
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
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
Survey to Identify Burdens and Unmet Needs of Patients With Epidermolysis Bullosa
This survey intends to collect information on key aspects of life with epidermolysis bullosa (EB), including diagnostic journey, treatment, management, daily living challenges, and overall psycho-social, socio-economic, academic…
- Trial name
- NCT03158662
- Testing
- Survey
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Amicus Therapeutics
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.
Epidermolysis Bullosa (EB), Epidermolysis Bullosa Simplex
To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive).
- Conditions
- Epidermolysis Bullosa (EB), Epidermolysis Bullosa Simplex, Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
- Trial name
- NCT03472287
- Testing
- Diacerein 1% Ointment
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Castle Creek Pharmaceuticals, LLC
Epidermolysis Bullosa Dystrophica, Recessive, Epidermolysis Bullosa Dystrophica, Dominant
A Double-blind, Randomized, Intra-subject Placebo-controlled, Multicenter, Multiple Dose Study, Evaluating Safety, Proof of Mechanism, Preliminary Efficacy and Systemic Exposure in Subjects With Confirmed DDEB or RDEB Diagnosis With One or More Pathogenic Mutations in Exon 73 in the COL7A1 Gene
A double-blind, randomized, intra-subject placebo-controlled, multicenter, multiple dose study, evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with confirmed DDEB or RDEB diagnosis…
- Trial name
- NCT03605069
- Testing
- QR-313
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 2 people
- Sponsor
- Phoenicis Therapeutics
Recessive Dystrophic Epidermolysis Bullosa
Extension Study to PTR-01-002 (A Study in Recessive Dystrophic Epidermolysis Bullosa (RDEB) Patients Previously Treated With PTR-01)
A sub-set of patients who participated in PTR-01-002 will be enrolled in an open-label study, if they meet the study eligibility criteria.
- Trial name
- NCT05143190
- Testing
- PTR-01
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Phoenix Tissue Repair, Inc.
Dystrophic Epidermolysis Bullosa
A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa
This is a pilot study designed to see if HP802-247, an investigational treatment with living human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis Bullosa (DEB).
- Trial name
- NCT01528306
- Testing
- HP802-247
- Sponsor
- Healthpoint
Recessive Dystrophic Epidermolysis Bullosa
Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa
The aim of this clinical trial is to investigate the efficacy (by monitoring overall improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of allo-APZ2-EB administered intravenously to patients with…
- Trial name
- NCT03529877
- Testing
- allo-APZ2-EB
- Where
- 6 sites in United States, Austria and 3 more
- Volunteers
- 16 people
- Sponsor
- RHEACELL GmbH & Co. KG
Epidermolysis Bullosa (EB)
An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
The objective is to characterize the continued safety of SD-101 cream containing 6% allantoin in the treatment of the skin in patients with Simplex, Recessive Dystrophic, or JEB-nH EB.
- Trial name
- NCT07482813
- Testing
- SD-101 Dermal Cream (6%)
- Volunteers
- 80 people
- Sponsor
- Paradigm Therapeutics