Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

Related Clinical Trial
Study of PTW-002 in Patients With Dominant or Recessive Dystrophic Epidermolysis Bullosa Due to Mutation(s) in Exon 73 of the COL7A1 Gene Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over) Growth Hormone in EB Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in People With Epidermolysis Bullosa. Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa Extension Study to PTR-01-002 Long-Term Follow-up Protocol A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa Improve Adherence to Weak or Strong Opioid Analgesics at the Time of Care in Children With Hereditary Epidermolysis Bullosa Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD) Topical Gentamicin Nonsense Suppression Therapy of EB The Efficacy and Safety of 3% Cannabidiol (CBD) Cream in Patients With Epidermolysis Bullosa: A Phase II/III Trial A Study of PTR-01 in Recessive Dystrophic Epidermolysis Bullosa Safety and Effectiveness Study of Allogeneic Umbilical Cord Blood-derived Mesenchymal Stem Cell in Patients With RDEB The Objective of This Study is to Compare the Efficacy and Safety of Beremagene Geperpavec (B-VEC) Topical Gel With That of Placebo for the Treatment of Dystrophic Epidermolysis Bullosa (DEB). Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa Randomised Double Blind Placebo Controlled Cross Over Design of the Efficacy of Topical Morphine for Inflammatory Pain in Children With Epidermolysis Bullosa Study of Cellutome System for Treatment of Individual Lesions in EB Pts Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa Biochemical Correction of Severe EB by Allo HSCT and “Off-the-shelf” MSCs Survey to Identify Burdens and Unmet Needs of Patients With Epidermolysis Bullosa Study of the Nutritional, Metabolic, and Body Composition Profile in Children and Adolescents With Epidermolysis Bullosa MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs Randomised Double Blind Crossover Placebo Controlled Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes Topical BPM31510 3.0% Cream in Patients With Epidermolysis Bullosa Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10) The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial Proof of Concept Study for a Dressing Glove Pregabalin Treatment for RDEB Pain and Itch Study of Alwextin® Cream in Treating Epidermolysis Bullosa A Study of the Efficacy and Safety of ABH001 in the Treatment of Patients With Epidermolysis Bullosa Who Have Wounds That Are Not Healing Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane Topical QR-313 in Dominant Dystrophic Epidermolysis Bullosa (DDEB) or Recessive Dystrophic Epidermolysis Bullosa (RDEB) Due to Mutation(s) in Exon 73 of the COL7A1gene Rigosertib for RDEB-SCC Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa Short Term Observational Study in DEB Patients Gentamicin for RDEB Clinical Trial to Assess Safety and Efficacy of Autologous Cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified in Patients With RDEB. Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Nonsense Mutation Patients Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa Allogeneic Stem Cell Transplantation (ALLOSCT) in Recessive Dystrophic Epidermolysis Bullosa (RDEB) Allogeneic Hematopoietic Stem Cell Transplant For Epidermolysis Bullosa Topical Beremagene Geperpavec (KB103) Gene Therapy to Restore Functional Collagen VII for the Treatment of Dystrophic Epidermolysis Bullosa A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) A Phase 1/2 Trial of PTR-01 in Adult Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB) Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Molecular Signatures of Cutaneous Squamous Cell Carcinoma During Recessive Dystrophic Epidermolysis Bullosa Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) MSC EVs in Dystrophic Epidermolysis Bullosa Mesenchymal Stromal Cells in Adults With Recessive Dystrophic Epidermolysis Bullosa Prospective, Longitudinal Natural History Study in Dystrophic Epidermolysis Bullosa Recessive Dystrophic Epidermolysis Bullosa Screening for Possible Gene Transfer Study of Immune Tolerance and Capacity for Wound Healing of Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB) Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate) Characteristics of Adult Patients With Recessive Dystrophic Epidermolysis Bullosa Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB) A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

Brief Title

Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

Official Title

Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

Brief Summary

      Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of
      cutaneous bullous lesion arising spontaneously or after mechanical trauma.

      These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no
      treatment available. Cares are consisting to dress lesions and to protect the skin.

      The investigators have recently observed on patients having residual expression of collagen
      VII that phenotype severity is modulated by activation degree of dermic metalloproteinase.
      The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be
      regulated this activity.

      The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease
      the number of cutaneous bullosa after four month of treatment.

      The primary outcome measure is the rate of patient presenting a decrease of 20% or more of
      the number of cutaneous bullosa.

      Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the
      average duration of cicatrisation and treatment tolerance.

      This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.

      When patients are included, they will be randomized and receive the treatment (or placebo)
      for 4 months.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

decrease of number of cutaneous bullosa

Secondary Outcome

 efficacity of treatment

Condition

Epidermolysis Bullosa Dystrophica

Intervention

Polyphenon E before Placebo

Study Arms / Comparison Groups

 1
Description:  patients receive the treatment in first and placebo in second part of study

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

October 2010

Completion Date

July 2013

Primary Completion Date

July 2013

Eligibility Criteria

        Inclusion Criteria:

          -  known mutation of COL7A1

        Exclusion Criteria:

          -  tea drinkers

          -  patient receiving induction treatment,protease inhibitor treatment

          -  liver failure
      

Gender

All

Ages

2 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christine Chiaverini, PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00951964

Organization ID

09-APN-01


Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire de Nice


Study Sponsor

Christine Chiaverini, PhD, Principal Investigator, dermatology department, Nice University Hospital


Verification Date

May 2014