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Clinical trials for Trifarotene

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    6 result(s) found for: Trifarotene. Displaying page 1 of 1.
    EudraCT Number: 2018-003272-12 Sponsor Protocol Number: 18-ICH-001 Start Date*: 2019-10-14
    Sponsor Name:Mayne Pharma LLC
    Full Title: A Phase 2 Randomized, Multi-center, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream...
    Medical condition: Lamellar ichthyosis (LI) Autosomal Recessive Ichthyosis with Lamellar Scale
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10023686 Lamellar ichthyosis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-003608-41 Sponsor Protocol Number: RD.06.SPR.204245 Start Date*: 2022-01-12
    Sponsor Name:Galderma S.A.
    Full Title: Evaluation of acne-induced hyperpigmentation during treatment of acne vulgaris subjects with trifarotene 50 µg/g cream versus vehicle cream over 24 weeks.
    Medical condition: Moderate acne vulgaris with acne-induced post-inflammatory hyperpigmentation (PIH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10000519 Acne vulgaris LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-006050-51 Sponsor Protocol Number: RD.06.SPR.202395 Start Date*: 2021-08-03
    Sponsor Name:Galderma S.A.
    Full Title: Evaluation of the risk of atrophic acne scar formation during treatment of acne vulgaris subjects with trifarotene 50 µg/g cream versus vehicle cream over 24 weeks
    Medical condition: acne vulgaris
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10000519 Acne vulgaris LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-002860-15 Sponsor Protocol Number: RD.06.SPR.18251 Start Date*: 2017-01-24
    Sponsor Name:Galderma R&D SNC
    Full Title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50μg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
    Medical condition: Acne Vulgaris
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10000519 Acne vulgaris LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2014-001755-23 Sponsor Protocol Number: RD.06.SPR.18250 Start Date*: 2014-11-25
    Sponsor Name:Galderma R&D SNC
    Full Title: A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 50μg/g CREAM IN SUBJECTS WITH ACNE VULGARIS
    Medical condition: Acne Vulgaris
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004858 10000519 Acne vulgaris LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-002540-13 Sponsor Protocol Number: RD.06.SPR.18252 Start Date*: 2016-01-13
    Sponsor Name:Galderma R&D SNC
    Full Title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50μg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
    Medical condition: Acne Vulgaris
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004858 10000519 Acne vulgaris LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) CZ (Completed)
    Trial results: View results
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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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