36. 表皮水疱症 Epidermolysis bullosa Clinical trials / Disease details


臨床試験数 : 160 薬物数 : 195 - (DrugBank : 47) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 124

  
24 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000214-42-ES
(EUCTR)
08/03/202217/12/2021INM-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2France;Serbia;Greece;Spain;Austria;Israel;Germany;Italy
2NCT05062070
(ClinicalTrials.gov)
November 15, 202121/9/2021Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa SimplexA Phase I/II, Closed Label, Randomized, Pilot Study for the Safety and Efficacy of TolaSure Gel, 5% w/w Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex (TAMES)Epidermolysis Bullosa SimplexDrug: TolaSure Topical Gel;Drug: Vehicle Topical GelBioMendics, LLCNULLNot yet recruiting18 YearsN/AAll5Phase 1United States
3EUCTR2021-000214-42-AT
(EUCTR)
01/08/202129/04/2021INM-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2France;Serbia;Greece;Austria;Israel;Germany;Italy
4NCT04908215
(ClinicalTrials.gov)
August 202126/5/2021INM-755 (Cannabinol) Cream for Treatment of Epidermolysis BullosaA Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (Cannabinol) Cream in Patients With Epidermolysis BullosaEpidermolysis Bullosa Simplex;Epidermolysis Bullosa, Junctional;Epidermolysis Bullosa Dystrophica;Kindler SyndromeDrug: INM-755 (cannabinol) cream;Drug: Vehicle CreamInMed Pharmaceuticals Inc.NULLNot yet recruiting12 YearsN/AAll20Phase 2NULL
5EUCTR2021-000214-42-GR
(EUCTR)
22/07/202122/06/2021INM-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2France;Serbia;Greece;Austria;Israel;Germany;Italy
6NCT03468322
(ClinicalTrials.gov)
October 20, 20188/3/2018A Double-blind, Intra-individual Comparison, POC Trial of AC-203 in EB PatientsA Double-blind, Intra-individual Comparison, Proof-of-concept Trial of Topical AC-203 in Patients With Inherited Epidermolysis BullosaInherited Epidermolysis BullosaDrug: AC-203;Drug: VehicleTWi Biotechnology, Inc.NULLCompleted2 YearsN/AAll9Phase 2Taiwan
7EUCTR2016-002066-32-DK
(EUCTR)
05/04/201817/01/2018A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;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
8EUCTR2016-002066-32-BE
(EUCTR)
23/03/201817/01/2018A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
192Phase 3Serbia;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
9EUCTR2016-002066-32-HR
(EUCTR)
26/02/201812/04/2018A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3Serbia;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
10EUCTR2016-002066-32-HU
(EUCTR)
08/01/201829/11/2017A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
164Phase 3Hong 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
11EUCTR2016-002066-32-IE
(EUCTR)
22/12/201707/03/2017A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;Greece;Spain;Ukraine;Ireland;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Belgium;Croatia;Denmark;Australia;Germany
12EUCTR2016-002066-32-GB
(EUCTR)
10/11/201713/02/2017A 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 LimitedNULLAuthorised-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): noSerbia;Greece;Spain;Ukraine;Ireland;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Mexico;Belgium;Croatia;Denmark;Australia;Germany
13EUCTR2016-002066-32-IT
(EUCTR)
18/10/201730/01/2018A 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 LimitedNULLAuthorised-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): noUnited States;Greece;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Belgium;Croatia;Denmark;Australia;Germany
14EUCTR2016-002066-32-GR
(EUCTR)
16/10/201705/05/2017A 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 LimitedNULLAuthorised-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): noSerbia;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
15EUCTR2016-002066-32-AT
(EUCTR)
26/09/201708/03/2017A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;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
16NCT03068780
(ClinicalTrials.gov)
March 29, 201727/2/2017Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis BullosaDouble 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 BullosaEpidermolysis BullosaDrug: Oleogel-S10;Drug: PlaceboAmryt Research LimitedNULLActive, not recruitingN/AN/AAll223Phase 3United 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
17EUCTR2016-002066-32-ES
(EUCTR)
16/03/201710/03/2017A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3United States;Greece;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Mexico;Croatia;Australia;Germany
18NCT03016715
(ClinicalTrials.gov)
May 20169/1/2017Using Topical Sirolimus 2% for Patients With Epidermolysis Bullous Simplex (EBS) StudyA 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 SyndromeDrug: Sirolimus 2%;Drug: VehiclePremier Specialists, AustraliaNULLRecruiting5 YearsN/AAll8Phase 2Australia
19NCT02960997
(ClinicalTrials.gov)
May 201615/6/2016Using Topical Sirolimus 2% for Patients With Epidermolysis Bullous Simplex (EBS) StudyA 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 SyndromeDrug: Sirolimus, 2%;Drug: VehicleStanford UniversityNULLActive, not recruiting4 YearsN/AAll8Phase 2United States
20NCT02014376
(ClinicalTrials.gov)
January 6, 201412/12/2013Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis BullosaA Phase 2b, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Effectiveness and Safety of SD-101 Cream in Subjects With Epidermolysis BullosaEpidermolysis BullosaDrug: SD-101 dermal cream (3%);Drug: SD-101 Dermal Cream (6%);Drug: Vehicle (SD-101 0%)Scioderm, Inc.Amicus TherapeuticsCompleted6 MonthsN/AAll48Phase 2United States
21EUCTR2021-000214-42-FR
(EUCTR)
26/04/2021INM-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.NULLNAFemale: yes
Male: yes
20Phase 2Serbia;France;Greece;Austria;Israel;Germany;Italy
22EUCTR2016-002066-32-CZ
(EUCTR)
29/11/2017A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United 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
23EUCTR2021-000214-42-DE
(EUCTR)
19/04/2021INM-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.NULLNAFemale: yes
Male: yes
20Phase 2France;Serbia;Greece;Austria;Israel;Germany;Italy
24EUCTR2016-002066-32-DE
(EUCTR)
09/03/2017A 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 LimitedNULLNAFemale: yes
Male: yes
192Phase 3Serbia;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