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Clinical trials for Betulin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    4 result(s) found for: Betulin. Displaying page 1 of 1.
    EudraCT Number: 2012-000777-23 Sponsor Protocol Number: BSH-12 Start Date*: 2012-07-05
    Sponsor Name:Birken AG
    Full Title: Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in...
    Medical condition: Split-Thickness Skin Graft Donor Sites
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004865 10041667 Split thickness skin graft LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) FI (Completed) AT (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-002066-32 Sponsor Protocol Number: BEB-13 Start Date*: 2017-11-10
    Sponsor Name:Amryt Research Limited
    Full Title: 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
    Medical condition: Inherited Epidermolysis Bullosa
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) AT (Completed) DE (Completed) ES (Ongoing) GR (Completed) HU (Completed) CZ (Completed) BE (Completed) DK (Completed) IT (Completed) HR (Completed) FR (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2012-003390-26 Sponsor Protocol Number: BSG-12 Start Date*: 2012-12-18
    Sponsor Name:Birken AG
    Full Title: Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in...
    Medical condition: Split-Thickness Skin Graft Donor Sites
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10041667 Split thickness skin graft LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) GR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-000362-38 Sponsor Protocol Number: BBW-11 Start Date*: 2012-06-18
    Sponsor Name:Birken AG
    Full Title: Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in...
    Medical condition: Superficial partial-thickness (grade 2a) burn wounds
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022117 - Injury, poisoning and procedural complications 10006802 Burns second degree PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) GB (Completed)
    Trial results: View results
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    Query did not match any studies.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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