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Epidermolysis Bullosa clinical trials

View clinical trials related to Epidermolysis Bullosa.

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NCT ID: NCT05143190 Completed - Clinical trials for Recessive Dystrophic Epidermolysis Bullosa

Extension Study to PTR-01-002 (A Study in Recessive Dystrophic Epidermolysis Bullosa (RDEB) Patients Previously Treated With PTR-01)

Start date: December 2, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT05141838 Recruiting - Osteoporosis Clinical Trials

Vitamin D Status and Bone Metabolism Status in Children With Congenital Epidermolysis Bullosa

Start date: November 21, 2020
Phase: Phase 4
Study type: Interventional

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 with congenital epidermolysis bullosa.

NCT ID: NCT05111600 Recruiting - Clinical trials for 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

HOLOGENE 5
Start date: July 15, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

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 LAMB3-gamma retroviral vector. The purpose of this study is to demonstrate the safety and efficacy after one or more treatments with genetically corrected cultured epidermal autograft (Hologene 5) for restoration of the epidermis in patients with generalized intermediate LAMB3-dependent Junctional Epidermolysis Bullosa.

NCT ID: NCT05062070 Completed - Clinical trials for Epidermolysis Bullosa Simplex

Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex

TAMES
Start date: May 5, 2022
Phase: Phase 1
Study type: Interventional

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 severe epidermolysis bullosa simplex (i.e., EBS-Dowling Meara). A total of 10, severe EBS patients, males and females ages 18 years and older, will be enrolled. Patients will apply TolaSure and Vehicle Gel once-daily for a maximum of 10 weeks.

NCT ID: NCT05033574 Active, not recruiting - Clinical trials for Epidermolysis Bullosa

The State of Sexual Development in Children With Inherited Epidermolysis Bullosa

Start date: December 8, 2020
Phase:
Study type: Observational

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 simplex, junctional epidermolysis bullosa, Kindler syndrome.

NCT ID: NCT04917887 Recruiting - Clinical trials for Recessive Dystrophic Epidermolysis Bullosa

Long-Term Follow-up Protocol

Start date: May 25, 2021
Phase:
Study type: Observational

The main objective of this prospective, observational, long-term follow-up (LTFU) study is to evaluate the long-term safety profile of the gene therapy products evaluated by Krystal Biotech, Inc. which have a shared backbone of HSV-1, in participants who received at least one dose of investigational product (IP).

NCT ID: NCT04917874 Completed - Clinical trials for Recessive Dystrophic Epidermolysis Bullosa

A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa

Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

This is a 112-week (approximately two-year) open-label extension study of Beremagene Geperpavec (B-VEC), for participants aged 2 months and older, who have been diagnosed with Dystrophic Epidermolysis Bullosa (DEB). Participants will be dosed weekly with the topical B-VEC therapy. The primary endpoint will be to assess long term safety and tolerability of the topical gene therapy. The study is for those who participated in Phase 3 study, as well as, new participants who were unable to participate in the Phase 3 study, who meet all enrollment criteria.

NCT ID: NCT04908215 Completed - Clinical trials for Epidermolysis Bullosa Dystrophica

INM-755 (Cannabinol) Cream for Treatment of Epidermolysis Bullosa

Start date: December 28, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety of INM-755 (cannabinol) cream and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with epidermolysis bullosa (EB).

NCT ID: NCT04853667 Completed - Clinical trials for Epidermolysis Bullosa

Improve Adherence to Weak or Strong Opioid Analgesics at the Time of Care in Children With Hereditary Epidermolysis Bullosa

ODEB
Start date: April 29, 2021
Phase:
Study type: Observational

Hereditary epidermolysis bullosa (HEB) are rare genodermatoses, clinically characterized by epithelial and subepithelial fragility leading to the formation of blisters and spontaneous erosions on skin at the slightest contact, with possible mucosal damage. The care of these patients consists of therapeutic baths leading to renew bandages that sometimes covering the entire integument. These are difficult, delicate and painful moments that patients experience daily at home. For an unexplained reason for 70 to 80% of them, the weak or strong opioid analgesics, deemed necessary and prescribed for good pain control, are not taken on a regular basis as a premedication for baths and dressing changes. The aim of the study is to understand the child's brakes on taking weak or strong opioid analgesics at the time of care and the parents' difficulties in giving these treatments by means of individual interviews.

NCT ID: NCT04757727 Recruiting - Clinical trials for Dystrophic Epidermolysis Bullosa

Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)

Start date: January 1, 2021
Phase:
Study type: Observational

Dystrophic epidermolysis bullosa is a rare genetic pathology resulting in fragility of the skin and mucous membranes, causing bubbles and wounds following trauma. Scarring is pathological with a tendency to retraction. The gynecological and in particular the vulvovaginal mucous membranes can be affected but no description of any series is available in the literature. Likewise, some of these patients have a sexual and obstetrical life, despite sometimes-severe damage, but again no specific data is available. The investitigator thus wish to carry out a non-interventional multicenter prospective descriptive study. Better knowledge of gynecological semiology in patients with EBD will allow better adaptation of gynecological follow-up, screening for STDs and gynecological cancers, as well as possible specific complications. This study would eventually allow the draw up of recommendations for our gynecologist / obstetrician colleagues.