DDrare: Database of Drug Development for Rare Diseases

36. 表皮水疱症
［臨床試験数：147，薬物数：170（DrugBank：40），標的遺伝子数：32，標的パスウェイ数：113］

Searched query = "Epidermolysis bullosa", "EBS", "JEB", "DDEB", "RDEB", "Kindler syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 3400930060797; ABH001; AC-203; AGLE 102; ALLANTOIN; ALLO-ASC-DFU; ASC; AVCN583601 (3% Cannabidiol cream); Allantoin; Allo-APZ2-EB; Allogeneic mesenchymal stromal cells; Allogeneic skin-derived ABCB5-positive mesenchymal stem cells; Allogenic mesenchymal stromal cells; Alwextin cream; Anti-thymocyte globulin; BIOOPA dressing; BIRCH BARK EXTRACT; Birch bark extract; Blood test; Botulinic toxin; Broccoli; Busilvex; Busulfan; CALCIPOTRIOL; CCP-020; COL7A1-SIN retroviral vector engineered autologous tissue-engineered skin; CX501; Calcipotriol; Cannabidiol; Cell transplantation; Cultured allogeneic fibroblasts; Cyclophosphamide; Cyclosporine; Cyclosporine A; Células madre mesenquimales haploidénticas derivadas de médula ósea; DIACEREIN; Device: Occlusive non adherent dressing; Diacerein; Diacerein 1% Ointment; Diacerein 1% ointment; Diacerin cream; Donor mesenchymal stem cell infusions; Dysport; Dysport® (Botulinumtoxin A (Btx A)); EB-101; Episalvan gel; Erythrocine; Erythrocine oral; Erythromycin; Erythromycine; Ex-vivo expanded autologous human keratinocytes suspension containing epidermal stem cells genetically modified with a gamma-retroviral (rv) vector expressing the full-length LAMB3 cDNA.; FCX-007 (debcoemagene autoficel; FLudarabine; Fibroblasts; Fludarabine; Fludarabine phosphate; Gene-modified autologous fibroblasts; Genetically corrected cultured epidermal autograft (ATMP); Gentamicin; Gentamicin Sulfate; Gentamicin Sulfate, Injectable; Gentamicin sulfate 0.1% ointment; Granulocyte Colony Stimulating Factor; Granulocyte Colony Stimulating Factor (GCSF); HOLOGENE17; HOLOGENE7; HP802-247; Hologene 5; Human Allogeneic WJ-MSCs; Human Umbilical Cord Blood-derived Mesenchymal Stem Cells; Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh; Human fibroblast-derived dermal substitute, Dermagraft; ICX-RHY-013; Infectogenta; Isotretinoin; Ixekizumab; Jojoba oil; Jojoba oil with broccoli sprout extract; LOSARTAN POTASSIUM; LZRSE-Col7A1 Engineered Autologous Epidermal Sheets; Losartan; Losartan HEXAL; Losartan potassium; MESENCHYMAL STEM CELLS (MSCS); Mesenchymal Stem Cells extracted from bone marrow; Mesenchymal Stromal Cells; Mesenchymal stem cells derived from bone marrow (BM-MSCs); Mesenchymal stromal cells; Methoxsalen; Morphine; Morphine sulphate in intrasite gel; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Na; Normal saline; ON 01910.NA; ON 01910.Na; Oleogel-S10; Oral erythromycin; Other: Control wound treatment; Other: Quality-of-Life Assessment; POLYPHENON E; PTR-01; Phosphate; Polyphenon E; Potassium; Pregabalin; Procedure: Bone marrow infusion; Procedure: Bone marrow or umbilical cord blood (UCG) stem cell transplantation; Procedure: Mesenchymal stem cell transplantation; Procedure: hematopoietic bone marrow transplantation; Psorcutan-Ointment; QR-313; QR-313 Gel for Topical (Cutaneous) Administration; REGE pro dressing; RGN-137; Radiation: Total Body Irradiation; Radiation: Total body irradiation; Reduced Intensity Transplant conditioning; Rigosertib; Rigosertib Oral Capsules / Rigosertib Intravenous; Rigosertib Sodium; Rituximab; Ropivacaine; SD-101; SD-101 Dermal Cream (6%); SD-101 dermal cream (3%); SD-101 dermal cream (6%); SD-101-6.0 cream; SIN LV Mediated ex vivo transduced autologous fibroblasts expressing codon-optimised COL7A1; SIN RV-mediated COL7A1 corrected autologous skin equivalent; See below for FCX-007 description); Sericare; Sericare®; Serlopitant; Serlopitant Tablet; SimpleCare; Sirolimus; Sirolimus 2%; Sirolimus, 2%; Sulfate; TC-MSC; THYMOGLOBULINE; Tacrolimus; Taltz; Taltz 80mg; Tetracyclin; Thymoglobulin; Thymoglobuline; Thymosin Beta 4; Thymosin beta 4; Topical BPM31510 3.0% Cream; Topical Beremagene Geperpavec; Topical beremagene geperpavec; Topical opiod; Transduced keratinocytes suspension, containing epidermal stem cells genetically corrected with a COL17A1-encoding retroviral vector; Transduced keratinocytes suspension, containing epidermal stem cells genetically corrected with a COL7A1-encoding retroviral vector; Transduced keratinocytes suspension, containing epidermal stem cells genetically corrected with a COL7A1-encoding retroviral vector, obtained from secondary culture of ex vivo expanded autologous human keratinocytes.; Trimethoprim; Triterpene dry extract from birch cork; Unavailable; VPD-737; Vehicle; Vehicle (SD-101 0%); WHARTON’S JELLY DERIVED MESENCHYMAL STEM CELLS; WJ-MSCs; Zorblisa; [Hologene 5 DS]; [allo-APZ2-EB]

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	EUCTR2018-000439-29-GB (EUCTR)	04/06/2018	22/03/2018	A Multi-center Study to Evaluate How CCP-020 (Diacerein 1% ointment) is Absorbed in the Blood and Removed from the Body in Patients with Epidermolysis Bullosa (EB)	A Multi-center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein after Maximum Use, Topical Administration of CCP-020 (Diacerein 1% ointment) to Patients with Epidermolysis Bullosa (EB)	Epidermolysis Bullosa (EB) 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: Diacerein Product Code: CCP-020 INN or Proposed INN: DIACEREIN	Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	4	Phase 1	United States;France;Netherlands;Germany;United Kingdom
2	NCT03472287 (ClinicalTrials.gov)	May 18, 2018	14/3/2018	To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)	A Multi-Center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein After Maximum Use, Topical Administration of CCP-020 (Diacerein 1% Ointment) to Patients With Epidermolysis Bullosa (EB)	Epidermolysis Bullosa (EB);Epidermolysis Bullosa Simplex;Dystrophic Epidermolysis Bullosa;Junctional Epidermolysis Bullosa	Drug: Diacerein 1% Ointment	Castle Creek Pharmaceuticals, LLC	NULL	Completed	4 Years	N/A	All	11	Phase 1	United States;France;Netherlands;United Kingdom
3	EUCTR2017-003757-41-DE (EUCTR)	19/04/2018	21/02/2018	An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	Epidermolysis Bullosa Simplex (EBS) 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: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein	Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Austria;Australia;Israel;Netherlands;Germany;United Kingdom;Italy
4	EUCTR2017-003757-41-NL (EUCTR)	11/04/2018	06/12/2017	An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	Epidermolysis Bullosa Simplex (EBS) 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: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein	Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Austria;Australia;Israel;Germany;Netherlands;United Kingdom;Italy
5	EUCTR2017-003757-41-GB (EUCTR)	19/02/2018	13/11/2017	An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	Epidermolysis Bullosa Simplex (EBS) 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: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein	Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Austria;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
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
6	EUCTR2017-003757-41-FR (EUCTR)	07/02/2018	17/10/2018	An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	Epidermolysis Bullosa Simplex (EBS) 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: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein	Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Austria;Australia;Israel;Netherlands;Germany;United Kingdom
7	EUCTR2017-003757-41-AT (EUCTR)	04/01/2018	29/11/2017	An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	Epidermolysis Bullosa Simplex (EBS) 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: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein	Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	84	Phase 2	France;United States;Australia;Austria;Israel;Netherlands;Germany;Italy;United Kingdom
8	NCT03389308 (ClinicalTrials.gov)	December 1, 2017	19/12/2017	Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex	An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex (EBS)	Epidermolysis Bullosa;Epidermolysis Bullosa Simplex	Drug: diacerein 1% ointment	Castle Creek Pharmaceuticals, LLC	NULL	Completed	6 Months	99 Years	All	51	Phase 2	United States
9	EUCTR2016-004427-24-AT (EUCTR)	10/10/2017	30/05/2017	An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study]	Epidermolysis Bullosa Simplex (EBS) 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]		Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Australia;Austria;Israel;Netherlands;Germany;Italy;United Kingdom
10	EUCTR2016-004427-24-NL (EUCTR)	06/09/2017	23/06/2017	An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study]	Epidermolysis Bullosa Simplex (EBS) 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]		Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Austria;Australia;Israel;Germany;Netherlands;Italy;United Kingdom
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
11	EUCTR2016-004427-24-DE (EUCTR)	24/08/2017	23/05/2017	An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study]	Epidermolysis Bullosa Simplex (EBS) 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]		Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Austria;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
12	EUCTR2016-004427-24-GB (EUCTR)	21/07/2017	06/07/2017	An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study]	Epidermolysis Bullosa Simplex (EBS) 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: Diacerein Product Code: Diacerein INN or Proposed INN: DIACEREIN Other descriptive name: Diacerein	Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Austria;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
13	NCT03154333 (ClinicalTrials.gov)	June 1, 2017	10/5/2017	Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex	Epidermolysis Bullosa Simplex	Drug: diacerein 1% ointment;Drug: A placebo ointment	Castle Creek Pharmaceuticals, LLC	NULL	Terminated	4 Years	N/A	All	54	Phase 2	United States;Australia;Austria;France;Germany;Israel;Netherlands;United Kingdom
14	EUCTR2013-002034-21-AT (EUCTR)	16/12/2013	01/08/2013	Diacerein for butterfly children	Diacerein for the treatment of Epidermolysis bullosa simplex - Diacerein for EBS	Epidermolysis bullosa simplex - type Dowling-Meara;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: SimpleCare INN or Proposed INN: DIACEREIN	EB House Austria	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Austria
15	EUCTR2018-000439-29-NL (EUCTR)		27/09/2018	A Multi-center Study to Evaluate How CCP-020 (Diacerein 1% ointment) is Absorbed in the Blood and Removed from the Body in Patients with Epidermolysis Bullosa (EB)	A Multi-center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein after Maximum Use, Topical Administration of CCP-020 (Diacerein 1% ointment) to Patients with Epidermolysis Bullosa (EB)	Epidermolysis Bullosa (EB) 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: Diacerein Product Code: CCP-020 INN or Proposed INN: DIACEREIN	Castle Creek Pharmaceuticals, LLC	NULL	NA			Female: yes Male: yes	20	Phase 1	France;United States;Germany;Netherlands;United Kingdom
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
16	EUCTR2016-004427-24-FR (EUCTR)		21/08/2017	An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)	Epidermolysis Bullosa Simplex (EBS) 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]		Castle Creek Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Austria;Australia;Israel;Netherlands;Germany;United Kingdom

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

EUCTR2018-000439-29-GB
(EUCTR)

04/06/2018

22/03/2018

A Multi-center Study to Evaluate How CCP-020 (Diacerein 1% ointment) is Absorbed in the Blood and Removed from the Body in Patients with Epidermolysis Bullosa (EB)

A Multi-center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein after Maximum Use, Topical Administration of CCP-020 (Diacerein 1% ointment) to Patients with Epidermolysis Bullosa (EB)

Epidermolysis Bullosa (EB)
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: Diacerein
Product Code: CCP-020
INN or Proposed INN: DIACEREIN

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United States;France;Netherlands;Germany;United Kingdom

NCT03472287
(ClinicalTrials.gov)

May 18, 2018

14/3/2018

To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)

A Multi-Center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein After Maximum Use, Topical Administration of CCP-020 (Diacerein 1% Ointment) to Patients With Epidermolysis Bullosa (EB)

Epidermolysis Bullosa (EB);Epidermolysis Bullosa Simplex;Dystrophic Epidermolysis Bullosa;Junctional Epidermolysis Bullosa

Drug: Diacerein 1% Ointment

Castle Creek Pharmaceuticals, LLC

NULL

Completed

4 Years

N/A

All

Phase 1

United States;France;Netherlands;United Kingdom

EUCTR2017-003757-41-DE
(EUCTR)

19/04/2018

21/02/2018

An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

Epidermolysis Bullosa Simplex (EBS)
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: Diacerein
Product Code: Diacerein
INN or Proposed INN: DIACEREIN
Other descriptive name: Diacerein

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Austria;Australia;Israel;Netherlands;Germany;United Kingdom;Italy

EUCTR2017-003757-41-NL
(EUCTR)

11/04/2018

06/12/2017

An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

Product Name: Diacerein
Product Code: Diacerein
INN or Proposed INN: DIACEREIN
Other descriptive name: Diacerein

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Austria;Australia;Israel;Germany;Netherlands;United Kingdom;Italy

EUCTR2017-003757-41-GB
(EUCTR)

19/02/2018

13/11/2017

An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

Product Name: Diacerein
Product Code: Diacerein
INN or Proposed INN: DIACEREIN
Other descriptive name: Diacerein

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Austria;Australia;Israel;Netherlands;Germany;Italy;United Kingdom

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

EUCTR2017-003757-41-FR
(EUCTR)

07/02/2018

17/10/2018

An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

Product Name: Diacerein
Product Code: Diacerein
INN or Proposed INN: DIACEREIN
Other descriptive name: Diacerein

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Austria;Australia;Israel;Netherlands;Germany;United Kingdom

EUCTR2017-003757-41-AT
(EUCTR)

04/01/2018

29/11/2017

An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

Product Name: Diacerein
Product Code: Diacerein
INN or Proposed INN: DIACEREIN
Other descriptive name: Diacerein

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Australia;Austria;Israel;Netherlands;Germany;Italy;United Kingdom

NCT03389308
(ClinicalTrials.gov)

December 1, 2017

19/12/2017

Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex

An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex (EBS)

Epidermolysis Bullosa;Epidermolysis Bullosa Simplex

Drug: diacerein 1% ointment

Castle Creek Pharmaceuticals, LLC

NULL

Completed

6 Months

99 Years

All

Phase 2

United States

EUCTR2016-004427-24-AT
(EUCTR)

10/10/2017

30/05/2017

An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study]

Epidermolysis Bullosa Simplex (EBS)
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]

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Australia;Austria;Israel;Netherlands;Germany;Italy;United Kingdom

EUCTR2016-004427-24-NL
(EUCTR)

06/09/2017

23/06/2017

An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

Epidermolysis Bullosa Simplex (EBS)
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]

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Austria;Australia;Israel;Germany;Netherlands;Italy;United Kingdom

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

EUCTR2016-004427-24-DE
(EUCTR)

24/08/2017

23/05/2017

An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

Epidermolysis Bullosa Simplex (EBS)
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]

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Austria;Australia;Israel;Netherlands;Germany;Italy;United Kingdom

EUCTR2016-004427-24-GB
(EUCTR)

21/07/2017

06/07/2017

An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

Product Name: Diacerein
Product Code: Diacerein
INN or Proposed INN: DIACEREIN
Other descriptive name: Diacerein

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Austria;Australia;Israel;Netherlands;Germany;Italy;United Kingdom

NCT03154333
(ClinicalTrials.gov)

June 1, 2017

10/5/2017

Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS)

Epidermolysis Bullosa Simplex

Drug: diacerein 1% ointment;Drug: A placebo ointment

Castle Creek Pharmaceuticals, LLC

NULL

Terminated

4 Years

N/A

All

Phase 2

United States;Australia;Austria;France;Germany;Israel;Netherlands;United Kingdom

EUCTR2013-002034-21-AT
(EUCTR)

16/12/2013

01/08/2013

Diacerein for butterfly children

Diacerein for the treatment of Epidermolysis bullosa simplex - Diacerein for EBS

Epidermolysis bullosa simplex - type Dowling-Meara;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: SimpleCare
INN or Proposed INN: DIACEREIN

EB House Austria

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Austria

EUCTR2018-000439-29-NL
(EUCTR)

27/09/2018

A Multi-center Study to Evaluate How CCP-020 (Diacerein 1% ointment) is Absorbed in the Blood and Removed from the Body in Patients with Epidermolysis Bullosa (EB)

Product Name: Diacerein
Product Code: CCP-020
INN or Proposed INN: DIACEREIN

Castle Creek Pharmaceuticals, LLC

NULL

Female: yes
Male: yes

Phase 1

France;United States;Germany;Netherlands;United Kingdom

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

EUCTR2016-004427-24-FR
(EUCTR)

21/08/2017

An International Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

Epidermolysis Bullosa Simplex (EBS)
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]

Castle Creek Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Austria;Australia;Israel;Netherlands;Germany;United Kingdom