Clinical trials: Epidermolysis Bullosa, Junctional
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
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
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
Junctional Epidermolysis Bullosa
Clinical Trial to Assess Safety and Efficacy of Autologous Cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified in Patients With JEB (HOLOGENE17)
Prospective open-label, uncontrolled clinical study to assess the safety and efficacy of autologous cultured epidermal grafts containing epidermal stem cells genetically modified with the aid of a gamma-retroviral vector carrying…
- Trial name
- HOLOGENE17 (NCT03490331)
- Testing
- Transplantation surgery of genetically corrected cultured epidermal autograft (ATMP)
- Where
- Austria
- Volunteers
- 1 people
- Sponsor
- Holostem s.r.l.
Epidermolysis Bullosa
Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
The purpose of this study was to assess the continued safety of topical use of SD-101 cream (6%) in participants with Epidermolysis Bullosa (EB). Funding Source: FDA Office of Orphan Products Development
- Trial name
- NCT02090283
- Testing
- SD-101 dermal cream (6%)
- Where
- 7 sites in United States
- Volunteers
- 42 people
- Sponsor
- Scioderm, Inc.
Junctional Epidermolysis Bullosa Non-Herlitz Type
Open-label, Pivotal Clinical Trial to Confirm Efficacy and Safety of Autologous Grafts Containing Stem Cells Genetically Modified for Epidermis Restoration in Patients With Junctional Epidermolysis Bullosa
Prospective, multicenter and multinational, open-label, uncontrolled clinical study to assess the safety and efficacy of autologous cultured epidermal grafts containing epidermal stem cells genetically modified transduced with a…
- Trial name
- HOLOGENE 5 (NCT05111600)
- Testing
- Transplantation
- Where
- 2 sites in France, Italy
- Volunteers
- 2 people
- Sponsor
- Holostem s.r.l.
Junctional Epidermolysis Bullosa, Laryngo Onycho Cutaneous Syndrome
Genotype-phenotype Correlation in Junctional Epidermolysis Bullosa
This study will collect genetic and clinical information of junctional epidermolysis bullosa (JEB) patients. Computer analysis will be performed on genetic mutations found in these patients and this will be correlated with their…
- Trial name
- NCT04727268
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- University Hospital Birmingham NHS Foundation Trust
Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa, Junctional
CACIPLIQ20 in Wound Healing in Subjects With Epidermolysis Bullosa
Epidermolysis bullosa (EB) is a group of inherited disorders characterized by fragility of the skin and mucous membranes within the basement membrane zone.
- Trial name
- MATHBULL (NCT06007235)
- Testing
- CACIPLIQ20
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
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
Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers.
- Trial name
- FOSteR (NCT06423573)
- Testing
- Filsuvez
- Where
- 12 sites in United States, France and 4 more
- Volunteers
- 170 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
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
Junctional Epidermolysis Bullosa
Gentamicin for Junctional Epidermolysis Bullosa
Herlitz junctional epidermolysis bullosa (H-JEB), an incurable, fatal, inherited skin disease, is caused by loss-of-function mutations in the LAMA3, LAMB3 or LAMC2 genes, resulting in loss of laminin 332 and poor epidermal-dermal…
- Trial name
- NCT03526159
- Testing
- Gentamicin Sulfate
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Southern California
Junctional Epidermolysis Bullosa
Optimizing IV Gentamicin in JEB
Herlitz junctional epidermolysis bullosa (H-JEB), an incurable and fatal inherited skin disease, is caused by loss-of-function mutations in LAMA3, LAMB3 and LAMC2.
- Trial name
- NCT04140786
- Testing
- Gentamicin Sulfate, Injectable
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Southern California
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
Gut Microbiome, Gastrointestinal Microbiome
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
- Conditions
- Gut Microbiome, Gastrointestinal Microbiome, Autism, Autism Spectrum Disorder
- Trial name
- NCT04031469
- Testing
- There is no intervention in this study
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- ProgenaBiome
Epidermolysis Bullosa, Healthy
Computational Drug Repurposing for All EBS Cases
The study will compare gene expression differences between blistered and non-blistered skin from individuals with all subtypes of EB, as well as normal skin from non-EB subjects.
- Conditions
- Epidermolysis Bullosa, Healthy, Genetic Skin Disease, Epidermolysis Bullosa Simplex
- Trial name
- NCT03269474
- Testing
- Experimental Group
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Joyce Teng
Dermatologic Disease, Epidermolysis Bullosa
The State of Sexual Development in Children With Inherited Epidermolysis Bullosa
The aim of the study is to determine the state of sexual development in patients with inherited epidermolysis bullosa; the study is planned to include boys and girls aged 8 to 18 years with a diagnosis of epidermolysis bullosa…
- Conditions
- Dermatologic Disease, Epidermolysis Bullosa, Epidermolysis Bullosa Simplex, Epidermolysis Bullosa Dystrophica
- Trial name
- NCT05033574
- Testing
- Biochemical study of hormone levels, Ultrasound examination, Radiography of the hands
- Where
- Russia
- Volunteers
- 50 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
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 (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.