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Clinical trials for Ingenol mebutate

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
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  • 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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    11 result(s) found for: Ingenol mebutate. Displaying page 1 of 1.
    EudraCT Number: 2014-003218-98 Sponsor Protocol Number: LP0041-1120 Start Date*: 2015-03-26
    Sponsor Name:LEO Pharma A/S
    Full Title: Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.
    Medical condition: Actinic keratosis on the face or scalp
    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) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-005018-13 Sponsor Protocol Number: LP0041-22 Start Date*: 2012-04-26
    Sponsor Name:LEO Pharma A/S
    Full Title: Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
    Medical condition: Actinic keratosis on the face and scalp
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002863-88 Sponsor Protocol Number: LP0041-64 Start Date*: 2013-01-22
    Sponsor Name:LEO PHARMA A/S
    Full Title: A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen with Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas with Actinic Keratosis on Face/Scalp and Trunk/Extremities
    Medical condition: Actinic Keratosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002843-14 Sponsor Protocol Number: 0407 Start Date*: 2017-09-26
    Sponsor Name:Bispebjerg Hospital
    Full Title: Investigations of local skin reactions and safety after combined treatment of basal cell carcinoma using ablative fractional laser and ingenol mebutate - an exloratory, prospective, open-label phas...
    Medical condition: Safety and local skin reactions in patients with basal cell carcinoma after combined treatment of blative fractional laser and ingenol mebutate.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004146 Basal cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2012-003112-31 Sponsor Protocol Number: LP0041-63 Start Date*: 2013-07-13
    Sponsor Name:LEO Pharma A/S
    Full Title: Risk of Squamous Cell Carcinoma on Skin Areas Treated with Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
    Medical condition: Actinic keratosis on the face and scalp
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003691-23 Sponsor Protocol Number: 50621 Start Date*: 2014-11-10
    Sponsor Name:Maastricht Universitair Medisch Centrum
    Full Title: Topical Ingenol mebutate versus 5% 5-fluorouracil versus 5% Imiquimod versus photodynamic therapy in the treatment of actinic keratosis: a multi-center randomized efficacy and cost-effectiveness st...
    Medical condition: Actinic keratosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-002583-80 Sponsor Protocol Number: 38814 Start Date*: 2013-09-06
    Sponsor Name:Department of Dermatology, Bispebjerg University Hospital
    Full Title: Treatment of Actinic Keratoses with Ingenol Mebutate and topical glucocorticosteroid - a safety study
    Medical condition: Actinic Keratoses
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-005820-24 Sponsor Protocol Number: IIS-PICATO1264 Start Date*: 2016-09-09
    Sponsor Name:A.O.U. Università degli Studi della Campania "Luigi Vanvitelli"
    Full Title: A randomized study to evaluate the efficacy of ingenol mebutate on actinic keratoses and field cancerization compared to cryotherapy
    Medical condition: actinic keratoses and field cancerization
    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: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004465-24 Sponsor Protocol Number: EXP-1167 Start Date*: 2015-02-18
    Sponsor Name:LEO Pharma A/S
    Full Title: Safety and efficacy of repeat use of Picato® 0.05% in the treatment of anogenital warts
    Medical condition: Anogenital warts
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059313 Anogenital warts PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-000545-39 Sponsor Protocol Number: DERMAQ-001 Start Date*: 2018-04-30
    Sponsor Name:ASL 1 AVEZZANO-SULMONA-L'AQUILA
    Full Title: A randomized half-side comparative study of Methyl aminolevulinate (MAL, Metvix®) Daylight photodynamic therapy (DL-PDT) with or without pre-treatment with calcitriol (Silkis®) for Actinic Keratosi...
    Medical condition: Actinic Keratosis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004858 10020648 Hyperkeratoses HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003804-21 Sponsor Protocol Number: DFD-07-CD-001 Start Date*: 2015-11-12
    Sponsor Name:Promius Pharma LLC
    Full Title: Multi-centre, Randomized, Double-blind, Placebo-Controlled Pilot Safety and Efficacy Study of 8 Weeks of Treatment with DFD-07 for Actinic Keratosis of the Face and Scalp
    Medical condition: Actinic Keratosis (AK)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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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