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Clinical trials for Keratinization

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 ).  
     
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    5 result(s) found for: Keratinization. Displaying page 1 of 1.
    EudraCT Number: 2013-001796-20 Sponsor Protocol Number: RD.03.SPR.40214E Start Date*: 2013-12-17
    Sponsor Name:Galderma R&D SNC
    Full Title: Efficacy, safety and pharmacokinetics of 2 concentrations and 2 dosage regimens of CD5789 in subjects with Lamellar Ichthyosis
    Medical condition: Lamellar Ichthyosis
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10023686 Lamellar ichthyosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004382-83 Sponsor Protocol Number: ALA-AK-CT009 Start Date*: 2016-06-09
    Sponsor Name:Biofrontera Bioscience GmbH
    Full Title: A randomized, observer-blind, intra-individual phase III study to evaluate the safety and efficacy of BF 200 ALA (Ameluz®) in combination with daylight-PDT (photodynamic therapy) in comparison with...
    Medical condition: Actinic keratosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-000486-72 Sponsor Protocol Number: ALA-AK-CT010 Start Date*: 2017-07-28
    Sponsor Name:Biofrontera Bioscience GmbH
    Full Title: A randomized, double-blind, intra-individual, multi-center phase III study to evaluate the safety and efficacy of BF 200 ALA (Ameluz®) versus placebo in the treatment of mild to severe actinic kera...
    Medical condition: Actinic keratosis (AK)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002510-12 Sponsor Protocol Number: ALA-AK-CT007 Start Date*: 2013-08-27
    Sponsor Name:Biofrontera Bioscience GmbH
    Full Title: A randomized, double-blind, phase III multi-center study to evaluate the safety and efficacy of BF-200 ALA (Ameluz®) versus placebo in the field-directed treatment of mild to moderate actinic kerat...
    Medical condition: Actinic keratosis (AK)
    Disease: Version SOC Term Classification Code Term Level
    16.0 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-003469-36 Sponsor Protocol Number: THEA_HLF_1/21 Start Date*: 2021-09-17
    Sponsor Name:Laboratorios Théa, S.A.
    Full Title: “Prospective evaluation of the efficacy and safety of topical hydrocortisone treatment on clinical signs and symptoms of dry eye disease associated with moderate meibomian gland dysfunction”
    Medical condition: Dry Eye (DE) and Meibomian gland dysfunction (MGD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10015919 - Eye disorders 10013774 Dry eye PT
    20.1 10015919 - Eye disorders 10065062 Meibomian gland dysfunction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
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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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