Clinical trials: Epidermolysis Bullosa
Dystrophic Epidermolysis Bullosa
Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa
This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is effective as a treatment of Dystrophic Epidermolysis Bullosa (EB). Patients will receive one course of treatment with the study drug.
- Trial name
- NCT01538862
- Testing
- Granulocyte Colony Stimulating Factor (GCSF)
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Vanderbilt University Medical Center
Epidermolysis Bullosa
Establishment of the National Epidermolysis Bullosa Registry
OBJECTIVES: I. Develop a large roster of well-characterized patients with various forms of inherited and acquired epidermolysis bullosa (EB). II.
- Trial name
- NCT00004761
- Sponsor
- National Center for Research Resources (NCRR)
Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population.
- Conditions
- Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
- Trial name
- REVIVE (NCT06917690)
- Testing
- Oleogel-S10
- Where
- 6 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Recessive Dystrophic Epidermolysis Bullosa
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
The purpose of this study is to determine whether administration of FCX-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with…
- Trial name
- DEFI-RDEB (NCT04213261)
- Testing
- FCX-007 (dabocemagene autoficel; see below for FCX-007 description)
- Where
- 5 sites in United States
- Volunteers
- 6 people
- Sponsor
- Castle Creek Biosciences, LLC.
Junctional Epidermolysis Bullosa, Epidermolysis Bullosa (EB)
Pilot Study of ELK-003 Eye Drops for Treating Ocular Manifestations of Epidermolysis Bullosa
This study consists of two phases: an Observational Phase to evaluate the natural history of ocular manifestations in subjects with Dystrophic and Junctional Epidermolysis Bullosa, followed by a Treatment Phase to assess the…
- Conditions
- Junctional Epidermolysis Bullosa, Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa
- Trial name
- GOTAS-ELK-EB (NCT06713434)
- Testing
- ELK-003 (Standarized Amniotic Fluid Secretome Eye Drops)
- Where
- Chile
- Volunteers
- 20 people
- Sponsor
- Fundación DEBRA Chile, Niños Piel de Cristal
Epidermolysis Bullosa
Allogeneic Stem Cell Transplantation (ALLOSCT) in Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Reduced Intensity Conditioning (RIC) and Allogeneic Stem Cell Transplantation (AlloSCT) from family-related donors and unrelated cord blood (UCB) donors will be safe and well tolerated in selected patients with RDEB.
- Trial name
- RDEB (NCT00881556)
- Testing
- Palifermin, Fludarabine, Busulfan
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Columbia University
Bullosa Epidermolysis, Vitamin D Deficiency
Vitamin D Status and Bone Metabolism Status in Children With Congenital Epidermolysis Bullosa
This retrospective prospective study is aimed at studying the level of vitamin D supply and identifying markers of bone tissue remodeling in order to develop approaches to the prevention of osteopenia and osteoporosis in children…
- Conditions
- Bullosa Epidermolysis, Vitamin D Deficiency, Osteoporosis, Osteopenia
- Trial name
- NCT05141838
- Testing
- Vitamin D, Oral nutritional supplement
- Where
- Russia
- Volunteers
- 110 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
Recessive Dystrophic Epidermolysis Bullosa
A Study of PTR-01 in Recessive Dystrophic Epidermolysis Bullosa
Protocol PTR-01-002 is a 3-part Phase 2, open-label study of PTR-01. While new patients will be enrolled, priority will be given to patients that satisfactorily completed study PTR-01-001.
- Trial name
- NCT04599881
- Testing
- PTR-01
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Phoenix Tissue Repair, Inc.
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 Simplex
Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS)
Epidermolysis bullosa simplex (EBS) is a rare genetic skin disease characterized by fragility of the skin and mucous membranes resulting in painful blisters and erosions after minor trauma.
- Trial name
- NCT03154333
- Testing
- diacerein 1% ointment
- Where
- 22 sites in United States, Australia and 6 more
- Volunteers
- 54 people
- Sponsor
- Castle Creek Pharmaceuticals, LLC
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
Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
The purpose of this study is to determine whether topical application of Ropivacaine is effective for treating refractory pain during dressing changes and so improve quality of life of patients (newborn, child, adolescent or…
- Trial name
- EBROPI (NCT03730584)
- Testing
- Ropivacaine, Blood test
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Blister, Wound of Skin
Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.
This is a three-part, Phase I, first-in-human study designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25.
- Conditions
- Blister, Wound of Skin, Epidermolysis Bullosa, Varicose Ulcer of Lower Limb
- Trial name
- NCT05378997
- Where
- Sweden
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Xinnate AB
Epidermolysis Bullosa (EB), Epidermolysis Bullosa Dystrophica
Curcumin-Based Photodynamic Therapy in Epidermolysis Bullosa: Wound Healing, Quality of Life, and Salivary Biomarkers
Epidermolysis bullosa (EB) is a rare condition that causes extreme fragility of the skin and mucous membranes, leading to the formation of painful blisters.
- Conditions
- Epidermolysis Bullosa (EB), Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa Acquisita
- Trial name
- CURE-EB (NCT07596927)
- Testing
- Curcumin-based photodynamic therapy
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- Universidade Ceuma
Recessive Dystrophic Epidermolysis Bullosa
Safety Study of Gene-modified Autologous Fibroblasts in Recessive Dystrophic Epidermolysis Bullosa
Recessive dystrophic epidermolysis bullosa (RDEB) is a severe form of blistering skin disease caused by mutations in COL7A1 gene.
- Trial name
- NCT02493816
- Testing
- Gene-modified autologous fibroblasts
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- King's College London
Squamous Cell Carcinoma
Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce…
- Trial name
- NCT06731933
- Testing
- BVEC
- Where
- 2 sites in United States, Italy
- Volunteers
- 16 people
- Sponsor
- Stanford University
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
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
Epidermolysis Bullosa
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
In this pilot study, APR-TD011 antimicrobial wound cleansing spray will be given to all enrolled patients with junctional EB (JEB) or dystrophic epidermolysis bullosa (DEB) with Staphylococcus aureus or Pseudomonas aeruginosa…
- Trial name
- NCT05533866
- Testing
- APR-TD011
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Northwestern University