36. 表皮水疱症 Epidermolysis bullosa Clinical trials / Disease details
臨床試験数 : 163 / 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05157958 (ClinicalTrials.gov) | November 1, 2022 | 2/12/2021 | Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa | Double Blind, Randomized, Phase II Clinical Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET Versus Vehicle Control in Dystrophic Epidermolysis Bullosa (DEB) Patients | Dystrophic Epidermolysis Bullosa | Biological: ALLO-ASC-SHEET;Other: Vehicle Control | Anterogen Co., Ltd. | NULL | Not yet recruiting | 4 Years | 60 Years | All | 6 | Phase 2 | NULL |
| 2 | EUCTR2021-000214-42-ES (EUCTR) | 08/03/2022 | 17/12/2021 | INM-755 cream for patients with EB. | A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa. | Epidermolysis bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Cannabinol (CBN) Product Code: INM-755 INN or Proposed INN: CANNABINOL | InMed Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | France;Serbia;Greece;Spain;Austria;Israel;Germany;Italy | ||
| 3 | NCT04908215 (ClinicalTrials.gov) | December 28, 2021 | 26/5/2021 | INM-755 (Cannabinol) Cream for Treatment of Epidermolysis Bullosa | A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (Cannabinol) Cream in Patients With Epidermolysis Bullosa | Epidermolysis Bullosa Simplex;Epidermolysis Bullosa, Junctional;Epidermolysis Bullosa Dystrophica;Kindler Syndrome | Drug: INM-755 (cannabinol) cream;Drug: Vehicle Cream | InMed Pharmaceuticals Inc. | NULL | Recruiting | 12 Years | N/A | All | 20 | Phase 2 | Austria;France;Germany;Greece;Israel |
| 4 | EUCTR2021-000214-42-AT (EUCTR) | 01/08/2021 | 29/04/2021 | INM-755 cream for patients with EB. | A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa. | Epidermolysis bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Cannabinol (CBN) Product Code: INM-755 INN or Proposed INN: CANNABINOL | InMed Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | France;Serbia;Greece;Austria;Israel;Germany;Italy | ||
| 5 | EUCTR2021-000214-42-GR (EUCTR) | 22/07/2021 | 22/06/2021 | INM-755 cream for patients with EB. | A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa. | Epidermolysis bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Cannabinol (CBN) Product Code: INM-755 INN or Proposed INN: CANNABINOL | InMed Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | France;Serbia;Greece;Austria;Israel;Germany;Italy | ||
| 6 | NCT03468322 (ClinicalTrials.gov) | October 20, 2018 | 8/3/2018 | A Double-blind, Intra-individual Comparison, POC Trial of AC-203 in EB Patients | A Double-blind, Intra-individual Comparison, Proof-of-concept Trial of Topical AC-203 in Patients With Inherited Epidermolysis Bullosa | Inherited Epidermolysis Bullosa | Drug: AC-203;Drug: Vehicle | TWi Biotechnology, Inc. | NULL | Completed | 2 Years | N/A | All | 9 | Phase 2 | Taiwan |
| 7 | EUCTR2016-002066-32-DK (EUCTR) | 05/04/2018 | 17/01/2018 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany | ||
| 8 | EUCTR2016-002066-32-BE (EUCTR) | 23/03/2018 | 17/01/2018 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany | ||
| 9 | EUCTR2016-002066-32-HR (EUCTR) | 26/02/2018 | 12/04/2018 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany | ||
| 10 | EUCTR2016-002066-32-HU (EUCTR) | 08/01/2018 | 29/11/2017 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | Hong Kong;Greece;Spain;Ireland;Austria;Israel;Chile;Colombia;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Denmark;Australia;Germany | ||
| 11 | EUCTR2016-002066-32-IE (EUCTR) | 22/12/2017 | 07/03/2017 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;Greece;Spain;Ukraine;Ireland;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Belgium;Croatia;Denmark;Australia;Germany | ||
| 12 | EUCTR2016-002066-32-GB (EUCTR) | 10/11/2017 | 13/02/2017 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Greece;Spain;Ukraine;Ireland;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Mexico;Belgium;Croatia;Denmark;Australia;Germany | ||
| 13 | EUCTR2016-002066-32-IT (EUCTR) | 18/10/2017 | 30/01/2018 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Belgium;Croatia;Denmark;Australia;Germany | ||
| 14 | EUCTR2016-002066-32-GR (EUCTR) | 16/10/2017 | 05/05/2017 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle (placebo) gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany | ||
| 15 | EUCTR2016-002066-32-AT (EUCTR) | 26/09/2017 | 08/03/2017 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany | ||
| 16 | NCT03068780 (ClinicalTrials.gov) | March 29, 2017 | 27/2/2017 | Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa | Double Blind, Randomised, Vehicle Controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa | Epidermolysis Bullosa | Drug: Oleogel-S10;Drug: Control gel | Amryt Research Limited | NULL | Completed | 21 Days | N/A | All | 223 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Chile;Colombia;Czechia;Denmark;France;Georgia;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Romania;Russian Federation;Serbia;Singapore;Spain;Switzerland;Ukraine;United Kingdom;Belgium;Croatia |
| 17 | EUCTR2016-002066-32-ES (EUCTR) | 16/03/2017 | 10/03/2017 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 19.1;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Phase 3 | United States;Greece;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Croatia;Australia;Germany | ||
| 18 | NCT03016715 (ClinicalTrials.gov) | May 2016 | 9/1/2017 | Using Topical Sirolimus 2% for Patients With Epidermolysis Bullous Simplex (EBS) Study | A Prospective, Double-Blind, Cross-Over, Pilot Study to Assess Safety and Efficacy of Topical Sirolimus 2% in the Treatment of Plantar Blistering in Patients With Epidermolysis Bullous Simplex (EBS) | Epidermolysis Bullosa Simplex;Epidermolysis Bullosa Simplex Kobner;Weber-Cockayne Syndrome | Drug: Sirolimus 2%;Drug: Vehicle | Premier Specialists, Australia | NULL | Recruiting | 5 Years | N/A | All | 8 | Phase 2 | Australia |
| 19 | NCT02960997 (ClinicalTrials.gov) | May 2016 | 15/6/2016 | Using Topical Sirolimus 2% for Patients With Epidermolysis Bullous Simplex (EBS) Study | A Prospective, Double-Blind, Cross-Over, Pilot Study to Assess Safety and Efficacy of Topical Sirolimus 2% in the Treatment of Plantar Blistering in Patients With Epidermolysis Bullous Simplex (EBS) | Epidermolysis Bullosa Simplex;Epidermolysis Bullosa Simplex Kobner;Weber-Cockayne Syndrome | Drug: Sirolimus, 2%;Drug: Vehicle | Stanford University | NULL | Active, not recruiting | 4 Years | N/A | All | 8 | Phase 2 | United States |
| 20 | NCT02014376 (ClinicalTrials.gov) | January 6, 2014 | 12/12/2013 | Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa | A Phase 2b, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Effectiveness and Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa | Epidermolysis Bullosa | Drug: SD-101 dermal cream (3%);Drug: SD-101 Dermal Cream (6%);Drug: Vehicle (SD-101 0%) | Scioderm, Inc. | Amicus Therapeutics | Completed | 6 Months | N/A | All | 48 | Phase 2 | United States |
| 21 | EUCTR2021-000214-42-FR (EUCTR) | 26/04/2021 | INM-755 cream for patients with EB. | A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa. | Epidermolysis bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Cannabinol (CBN) Product Code: INM-755 INN or Proposed INN: CANNABINOL | InMed Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | 20 | Phase 2 | Serbia;France;Greece;Austria;Israel;Germany;Italy | |||
| 22 | EUCTR2021-000214-42-DE (EUCTR) | 19/04/2021 | INM-755 cream for patients with EB. | A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa. | Epidermolysis bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Cannabinol (CBN) Product Code: INM-755 INN or Proposed INN: CANNABINOL | InMed Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | 20 | Phase 2 | France;Serbia;Greece;Austria;Israel;Germany;Italy | |||
| 23 | EUCTR2016-002066-32-DE (EUCTR) | 09/03/2017 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | NA | Female: yes Male: yes | 192 | Phase 3 | Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Germany | |||
| 24 | EUCTR2016-002066-32-CZ (EUCTR) | 29/11/2017 | A Clinical Trial which compare the safety and efficacy of a wound gel, the study treatment, or a sunflower oil-based vehicle gel in patients with Inherited Epidermolysis Bullosa (EB) | Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study | Inherited Epidermolysis Bullosa MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Episalvan gel Product Name: Oleogel-S10 INN or Proposed INN: Birch bark extract Other descriptive name: BIRCH BARK EXTRACT | Amryt Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Serbia;Hong Kong;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Austria;United Kingdom;Czech Republic;Hungary;Argentina;Brazil;Belgium;Singapore;Croatia;Romania;Georgia;Germany |