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Clinical trials for Alitretinoin

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   44336   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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    13 result(s) found for: Alitretinoin. Displaying page 1 of 1.
    EudraCT Number: 2006-003959-21 Sponsor Protocol Number: BAP00731 Start Date*: 2007-09-25
    Sponsor Name:Basilea Pharmaceutica Ltd.
    Full Title: Open label treatment of patients with chronic hand dermatitis who have participated in a clincal trial involving oral alitretinoin
    Medical condition: Relapsed Chronic Hand Dermatitis (CHaD) Refractory to Topical Therapy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066695 Chronic hand dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-003488-12 Sponsor Protocol Number: 54659 Start Date*: 2016-08-23
    Sponsor Name:University Medical Center Groningen
    Full Title: Efficacy of oral alitretinoin versus oral cyclosporine in patients with moderate to very severe hand eczema. A randomized prospective open-label trial with blinded outcome assessment.
    Medical condition: Hand eczema (HE) is a common condition with a 1-year period prevalence up to 10%. Systemic treatment with alitretinoin is registered for all clinical types of HE. However, it is especially effectiv...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-004776-20 Sponsor Protocol Number: BAP00626 Start Date*: 2006-03-27
    Sponsor Name:Basilea Pharmaceutica Ltd
    Full Title: Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis
    Medical condition: Severe Chronic Hand Dermatitis (CHaD) Refractory to Topical Therapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001447-37 Sponsor Protocol Number: 52232 Start Date*: 2015-07-09
    Sponsor Name:University Medical Center Groningen
    Full Title: Efficacy of oral alitretinoin versus oral azathioprine in patients with severe chronic non-hyperkeratotic hand eczema. A randomized prospective open-label trial with blinded outcome assessment.
    Medical condition: Hand eczema
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004741-27 Sponsor Protocol Number: DM14/11351 Start Date*: 2015-02-18
    Sponsor Name:University of Leeds
    Full Title: Comparison of Alitretinoin with PUVA as the first line treatment in patients with severe chronic hand eczema
    Medical condition: Severe chronic hand eczema
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10066558 Chronic eczema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-003543-16 Sponsor Protocol Number: LP0133-1528 Start Date*: 2022-07-28
    Sponsor Name:LEO Pharma A/S
    Full Title: A 24 week, randomised, assessor blinded, active-controlled, parallel group, phase 3, 2 arm trial to compare the efficacy and safety of delgocitinib cream 20 mg/g twice-daily with alitretinoin capsu...
    Medical condition: Chronic Hand Eczema
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Ongoing) FR (Completed) AT (Completed) PL (Completed) NO (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2010-020212-11 Sponsor Protocol Number: 2010-338 Start Date*: 2010-09-09
    Sponsor Name:Overlæge dr.med. Frederik Grønhøj
    Full Title: Enkelt dosis (single dosis) farmakokinetik af 9-cis-retinoic acid (Alitretinoin, Toctino®) hos patienter med moderat til svær lever insufficiens.
    Medical condition: At undersøge enkeltdosis-farmakokinetikken af 9-cis-RA (Alitretinoin, Toctino®) og dets metaboliter hos patienter med moderat til svær leverinsufficiens og frivillige raske forsøgspersoner.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10024678 Liver failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024131-16 Sponsor Protocol Number: UKM10_0019 Start Date*: 2011-05-06
    Sponsor Name:Universitätsklinikum Münster
    Full Title: Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study
    Medical condition: Αdult subjects of any ethnicity and either gender with Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythema...
    Disease: Version SOC Term Classification Code Term Level
    16.0 10040785 - Skin and subcutaneous tissue disorders 10056509 Cutaneous lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-017520-88 Sponsor Protocol Number: TUD-TOCYDD-044 Start Date*: 2010-09-29
    Sponsor Name:Medical Faculty, TU Dresden
    Full Title: Ciclosporin vs. Alitretinoin for severe atopic hand dermatitis. A randomized controlled investigator-initiated double-blind trial.
    Medical condition: Chronic atopic hand dermatitis, not responding to potent topical corticosteroids.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-022843-39 Sponsor Protocol Number: ATN117221 Start Date*: 2011-04-08
    Sponsor Name:GlaxoSmithKline R&D Ltd
    Full Title: Efficacy of oral alitretinoin treatment in patients with palmo-plantar pustulosis (PPP) inadequately responding to standard topical treatment
    Medical condition: Palmo-Plantar Pustulosis
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004858 10050185 Palmoplantar pustulosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001561-32 Sponsor Protocol Number: 201900237 Start Date*: 2020-04-28
    Sponsor Name:University Medical Center Groningen
    Full Title: Dupilumab in adults with severe chronic hand eczema with an inadequate response or intolerance to alitretinoin: a randomized, double-blind, placebo-controlled proof of concept efficacy study
    Medical condition: Hand eczema
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10066695 Chronic hand dermatitis LLT
    20.0 100000004858 10036145 Pompholyx eczema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-000432-85 Sponsor Protocol Number: BAP00091 Start Date*: 2004-08-05
    Sponsor Name:Basilea Pharmaceutica Ltd
    Full Title: Follow-up Efficacy and Safety Study of BAL4079 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Therapy
    Medical condition: Severe Chronic Hand Dermatitis (CHaD) Refractory to Topical Therapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) GB (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-000345-38 Sponsor Protocol Number: BAP00089 Start Date*: 2004-07-13
    Sponsor Name:Basilea Pharmaceutica Ltd
    Full Title: Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
    Medical condition: Severe Chronic Hand Dermatitis (CHaD) Refractory to Topical Therapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) HU (Completed) DK (Completed) GB (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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