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Clinical trials for Isotretinoin

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    20 result(s) found for: Isotretinoin. Displaying page 1 of 1.
    EudraCT Number: 2009-016241-25 Sponsor Protocol Number: ERI2005VER Start Date*: 2010-06-15
    Sponsor Name:VERISFIELD (UK) LTD, GREEK BRANCH
    Full Title: MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARATIVE WITH THE REFERENCE PRODUCT CLINICAL STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF THE THERAPY WITH THE COMBINATION ERYTHROMYCIN-ISOTRETINOIN/VER...
    Medical condition: MILD TO MODERATE ACNE (ACNE VULGARIS)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2004-000972-15 Sponsor Protocol Number: 1002 Start Date*: 2004-09-03
    Sponsor Name:Michael Larsen
    Full Title: DIAMETIB
    Medical condition: Diabetic retinopathy
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-002410-35 Sponsor Protocol Number: 10 0330 02 - 0486 Start Date*: 2006-12-11
    Sponsor Name:Almirall Hermal GmbH
    Full Title: Double-blind, double-dummy, randomized, placebo-controlled, five-armed, multi-centre phase II/III study to evaluate the efficacy and safety of different concentrations of isotretinoin versus doxycy...
    Medical condition: Patients aded 18 and older suffering from papulopustular rosacea (subtype II) or moderate phymateous rosacea (moderate subtype III) with a minimum grade 4 in the 'Global physicians's assessment sco...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-005270-10 Sponsor Protocol Number: NALISO-II-20-1 Start Date*: 2021-08-18
    Sponsor Name:LABORATOIRES SMB S.A
    Full Title: A randomized, partially blinded, parallel study to evaluate the effects of nacystelyn in combination with isotretinoin in the treatment of recalcitrant acne vulgaris.
    Medical condition: Recalcitrant acne vulgaris
    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: BG (Completed)
    Trial results: View results
    EudraCT Number: 2022-000459-35 Sponsor Protocol Number: TMB01-301 Start Date*: Information not available in EudraCT
    Sponsor Name:Timber Pharmaceuticals, LLC
    Full Title: Protocol Title: The ASCEND Study: A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 - with a Parallel Optional Maximal Use Arm - in the Treatment of RXLI (Xlinked) or ARC...
    Medical condition: Congenital ichthyosis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003606-33 Sponsor Protocol Number: PK 2008 03 Start Date*: 2009-01-15
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: Pilot study to investigate the feasibility of 13-cis-Retinoic acid pharmacokinetic monitoring in high-risk neuroblastoma
    Medical condition: High risk neuroblastoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029260 Neuroblastoma LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-004164-31 Sponsor Protocol Number: protocole ISOROS Start Date*: 2006-11-16
    Sponsor Name:Laboratoires BIORGA
    Full Title: Evaluation de l'efficacité de l'isotrétinoïne versus placebo à travers le taux de patients répondeurs chez des patients présentant une rosacée papulo-pustuleuse résistant au traitement classique. E...
    Medical condition: Rosacée papulo-pustuleuse résistant à un traitement classique
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-018077-31 Sponsor Protocol Number: 012010 Start Date*: 2010-11-25
    Sponsor Name:St. Anna Kinderkrebsforschung/CCRI
    Full Title: A PHASE I/II DOSE SCHEDULE FINDING STUDY FOR CH14.18/CHO CONTINUOUS INFUSION COMBINED WITH SUBCUTANEOUS ALDESLEUKIN (IL-2) IN PATIENTS WITH PRIMARY REFRACTORY OR RELAPSING NEUROBLASTOMA
    Medical condition: High-risk neuroblastoma patients having received at least one previous high dose treatment followed by stem cell rescue after conventional therapy fulfilling one of the following criteria: • Prima...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed) ES (Ongoing) DE (Completed) IT (Ongoing) GB (GB - no longer in EU/EEA) IE (Completed) PL (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021396-81 Sponsor Protocol Number: LINES Start Date*: 2011-06-15
    Sponsor Name:INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE DE VALENCIA
    Full Title: European Low and Intermediate Risk Neuroblastoma
    Medical condition: INTERMEDIATE AND LOW RISK NEUROBLASTOMA
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) DK (Completed) AT (Completed) IT (Completed) BE (Completed) NO (Completed) FR (Completed) IE (Completed) SE (Completed) PT (Completed) LT (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-005104-25 Sponsor Protocol Number: INV500 Start Date*: 2018-01-02
    Sponsor Name:Nova BioPharma Limited
    Full Title: Relative bioavailability and comparative pharmacokinetics of 13-CRA oral liquid and extracted capsule formulations: a randomised, open label, multi-dose, cross-over clinical trial in patients requi...
    Medical condition: Neuroblastoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    20.0 10029205 - Nervous system disorders 10029212 Nervous system neoplasms malignant NEC HLT
    20.0 10029205 - Nervous system disorders 10029211 Nervous system neoplasms malignant and unspecified NEC HLGT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-006366-29 Sponsor Protocol Number: IRST172.01 Start Date*: 2009-04-07
    Sponsor Name:ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
    Full Title: IMMUNOTHERAPY OF MAINTENANCE IN THE PATIENTS WITH METASTATIC MELANOMA, CLINICAL BENEFIT AFTER CHEMOTHERAPY
    Medical condition: There is a preclinical and clinical rational that supports a synergic effect of the combination of IL-2, RA and PEG-IFN. Maintenance therapy prolongs time to progression. It is also to note the lo...
    Disease: Version SOC Term Classification Code Term Level
    12.0 10027480 Metastatic malignant melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-002540-67 Sponsor Protocol Number: 2019-06 Start Date*: 2022-04-08
    Sponsor Name:Centre Oscar Lambret
    Full Title: Phase 2 trial evaluating metronomic chemotherapy in patients with relapsed or refractory Wilms tumor
    Medical condition: Wilms tumor
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029145 Nephroblastoma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-001489-17 Sponsor Protocol Number: SIOPENRNET003 Start Date*: 2006-11-17
    Sponsor Name:St. Anna Kinderkrebsforschung e.V.
    Full Title: High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)
    Medical condition: High Risk Neuroblastoma
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed) ES (Restarted) GB (GB - no longer in EU/EEA) BE (Completed) DK (Restarted) IT (Completed) IE (Completed) HU (Completed) FI (Completed) SI (Completed) PL (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004864-69 Sponsor Protocol Number: HSJD-HR-NB-Ch14.18 Start Date*: 2014-05-21
    Sponsor Name:Fundació Sant Joan de Deu de Barcelona
    Full Title: Phase II single arm institutional study to assess Dinutuximab combined with the cytokines granulocyte-macrophage colony stimulating factor (GM-CSF) and IL-2 in patients with high-risk neuroblastoma...
    Medical condition: High-risk neuroblastoma
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-001679-36 Sponsor Protocol Number: RORO2004 Start Date*: 2005-06-14
    Sponsor Name:Kožní ordinace
    Full Title: Prospektivní, otevřená, randomizovaná multicentrická studie hodnotící účinnost a bezpečnost kombinace isotretinoinu (Roaccutane® tobolky) a interferonu alfa 2a oproti samotnému interferonu alfa 2a ...
    Medical condition: Chirurgicky radikálně odstraněný histologicky verifikovaný primární kožní melanom ve stadiu IIB až IIIB podle nové AJCC 2003 klasifikace
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001392-22 Sponsor Protocol Number: RC16_0467 Start Date*: 2017-09-27
    Sponsor Name:CHU de Nantes
    Full Title: Randomized double-blind study on the benefit of spironolactone for treating acne of adult woman
    Medical condition: Acne vulgaris of adult woman
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10000496 Acne PT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-006482-16 Sponsor Protocol Number: EPO2006-AISSM04 Start Date*: 2007-05-16
    Sponsor Name:FISM ONLUS
    Full Title: COMPARISON BETWEEN EPOYETIN ALONE ET EPOYETIN ASSOCIATED TO DIFFERENTIATING TERAPY WITH ACID 13-CIS-RETINOICO AND VITAMIN D3 DIIDROXILATED IN MYELODISPLASTIC SYNDROMES WITHOUT BLASTS EXCESS.
    Medical condition: MYELODISPLASTIC SYNDROME
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002858-24 Sponsor Protocol Number: D-CA-60130-452 Start Date*: 2021-12-17
    Sponsor Name:Clementia Pharmaceuticals Inc, an Ipsen Company
    Full Title: A Phase 2, two-part, placebo-controlled, parallel-group, double-blind study to assess the efficacy and safety of 2 dosage regimens of oral IPN60130 for the treatment of fibrodysplasia ossificans pr...
    Medical condition: fibrodysplasia ossificans progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Ongoing) SE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) BE (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-022211-19 Sponsor Protocol Number: RD.03.SPR.40126 Start Date*: 2011-01-07
    Sponsor Name:GALDERMA R&D
    Full Title: PILOT STUDY TO EXPLORE EFFICACY AND SAFETY OF DIFFERENT DOSE REGIMENS OF CD5789 IN SUBJECTS WITH ACNE VULGARIS
    Medical condition: Acne vulgaris
    Disease: Version SOC Term Classification Code Term Level
    12.1 10000519 Acne vulgaris LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) HU (Completed)
    Trial results: Removed from public view
    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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