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Clinical trials for Severe cutaneous adverse reactions

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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    17 result(s) found for: Severe cutaneous adverse reactions. Displaying page 1 of 1.
    EudraCT Number: 2019-004139-21 Sponsor Protocol Number: CTU/2017/306 Start Date*: 2020-04-22
    Sponsor Name:University College London
    Full Title: A randomised prospective open label pilot trial comparing mycophenolate mofetil (MMF) with no immunosuppression in adults with limited cutaneous systemic sclerosis MINIMISE-Pilot (Mycophenolate in ...
    Medical condition: Limited cutaneous systemic sclerosis (lcSSc)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10042953 Systemic sclerosis LLT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10011380 CREST syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2005-004321-26 Sponsor Protocol Number: 1100.1452 Start Date*: 2006-02-17
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Case-Control Toxicogenomics Study to identify Unique Genetic Polymorphisms in Patients who have experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity within the First 8 weeks of Nev...
    Medical condition: The patient population for this study will be comprised of patients with HIV-1 infection who have taken or are currently taking nevirapine and who have (cases) or have not (controls) experienced sy...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2023-000462-33 Sponsor Protocol Number: 171-7151-202 Start Date*: 2023-04-19
    Sponsor Name:Intrepid Therapeutics, Inc.
    Full Title: An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects with Acn...
    Medical condition: Facial Acne Vulgaris
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-003162-42 Sponsor Protocol Number: M/37779/21 Start Date*: 2005-10-21
    Sponsor Name:Almirall Prodesfarma S.A.
    Full Title: A double-blind, randomized, parallel, multicenter, vehicle-controlled, left/right paired comparison to study the efficacy, safety and tolerability of 1% LAS 37779 cream administered once and twice ...
    Medical condition: patients with mild to moderate chronic plaque psoriasis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003964-30 Sponsor Protocol Number: BIOVAS Start Date*: 2020-10-22
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust
    Full Title: Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vascu...
    Medical condition: Non-ANCA associated vasculitides: 1. Giant cell arteritis (GCA) 2. Takayasu’s arteritis (TA) 3. Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN) 4. Relapsing p...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10047065 - Vascular disorders 10047115 Vasculitis PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-002258-10 Sponsor Protocol Number: IBRB-02 Start Date*: 2016-10-19
    Sponsor Name:Dermal Laboratories Ltd
    Full Title: SINCERE: A single-centre, assessor blind, randomised pilot study to evaluate the safety, tolerability and acceptability of RB Lotion compared to standard-of-care for Radiation Induced Skin Reaction...
    Medical condition: Radiation Induced Skin Reactions (RISR)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004863 10061103 Dermatitis radiation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002678-19 Sponsor Protocol Number: SP148MP201 Start Date*: 2018-03-20
    Sponsor Name:SmartPractice
    Full Title: Clinical Evaluation of Metal Panel Allergens: Aluminum, Copper, Manganese, Molybdenum, Tin, Titanium, Vanadium and Zinc Dose Response Study
    Medical condition: Metal induced contact dermatitis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10040785 - Skin and subcutaneous tissue disorders 10040785 Skin and subcutaneous tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-002861-19 Sponsor Protocol Number: MBL 0407 INT Start Date*: 2005-01-24
    Sponsor Name:LEO Pharma A/S
    Full Title: Long-term treatment of Scalp Psoriasis with Calciptriol plus Betamethasone dipropionate gel. A phase III safety study of a new gel containing calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as di...
    Medical condition: Psoriasis of the scalp Extent: Minimum 10% of the total scalp area Disease severity: Graded as "moderate", "severe", or "very severe" according to the investigator's global assessment of disease se...
    Disease: Version SOC Term Classification Code Term Level
    7.0 10037115 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000261-36 Sponsor Protocol Number: 1.0 Start Date*: 2021-01-27
    Sponsor Name:Holostem Terapie Avanzate s.r.l.
    Full Title: MULTICENTRE, OPEN-LABEL, UNCONTROLLED, PIVOTAL CLINICAL TRIAL TO CONFIRM THE EFFICACY AND SAFETY OF AUTOLOGOUS FIBRINCULTURED EPIDERMAL GRAFTS CONTAINING EPIDERMAL STEM CELLS GENETICALLY MODIFIED F...
    Medical condition: Inherited Epidermolysis Bullosa (EB) is a group of rare, devastating genetic disorders characterized by structural and mechanical fragility of skin and mucosal membranes, impairing the patient's qu...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-000729-13 Sponsor Protocol Number: 2020_0068 Start Date*: 2021-01-21
    Sponsor Name:Hôpital Foch
    Full Title: Evaluation of Glucocorticoids plus Rituximab compared to Glucocorticoids plus Placebo for the treatment of patients with newly-diagnosed or relapsing IgA vasculitis : A prospective, randomized, con...
    Medical condition: Patients with a diagnosis of IgAV according to Chapel Hill Consensus Conference definitions. Patients will require having a biopsy-proven diagnosis of IgAV.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-014582-51 Sponsor Protocol Number: MO-90020714 Start Date*: 2010-03-26
    Sponsor Name:Faculty of Medicine, Technische Universität München
    Full Title: Pilot study - sequential combination therapy using selective immunoglobulin apheresis and omalizumab in patients with severe atopic dermatitis and elevated total IgE levels
    Medical condition: Patients with severe Atopic dermatitis and total IgE-level > 700 IU/ml (potentially associated with bronchial asthma and/or allergic rhinitis)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10002198 Anaphylactic reaction LLT
    12.0 10040400 Serum sickness LLT
    12.0 10043554 Thrombocytopenia LLT
    12.0 10019211 Headache LLT
    12.0 10028810 Nasopharyngitis LLT
    12.0 10040753 Sinusitis LLT
    12.0 10022000 Influenza LLT
    12.0 10006451 Bronchitis LLT
    12.0 10017888 Gastroenteritis LLT
    12.0 10034835 Pharyngitis LLT
    12.0 10047461 Viral infection LLT
    12.0 10034844 Pharyngolaryngeal pain LLT
    12.0 10011224 Cough LLT
    12.0 10039083 Rhinitis LLT
    12.0 10028735 Nasal congestion LLT
    12.0 10039085 Rhinitis allergic LLT
    12.0 10012727 Diarrhea LLT
    12.0 10028813 Nausea LLT
    12.0 10013946 Dyspepsia LLT
    12.0 10003988 Back pain LLT
    12.0 10003239 Arthralgia LLT
    12.0 10028411 Myalgia LLT
    12.0 10033425 Pain in extremity LLT
    12.0 10041014 Sleepiness LLT
    12.0 10046735 Urticaria LLT
    12.0 10015587 Exanthema LLT
    12.0 10037087 Pruritus LLT
    12.0 10012485 Dermatitis photosensitive LLT
    12.0 10000357 Accelerated hair loss LLT
    12.0 10033775 Paraesthesia LLT
    12.0 10042772 Syncope LLT
    12.0 10064973 Allergic bronchospasm LLT
    12.0 10001736 Allergic vasculitis LLT
    12.0 10053354 Blood pressure orthostatic abnormal LLT
    12.0 10063927 Orthostatic intolerance LLT
    12.0 10000188 Abnormal weight gain LLT
    12.0 10030095 Oedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002194-10 Sponsor Protocol Number: RV4421A2013147 Start Date*: 2014-11-10
    Sponsor Name:Pierre Fabre Dermo-Cosmétique
    Full Title: An intra-individual randomized controlled study to evaluate the efficacy and tolerance of the product RV4421A BS0042 in association with a moderately potent topical corticosteroid in adults with At...
    Medical condition: Atopic Dermatitis (arms, popliteal fossa)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-005872-41 Sponsor Protocol Number: QTZ-EC-0004 Start Date*: 2012-04-25
    Sponsor Name:Astellas Pharma Europe Ltd.
    Full Title: QUTENZA versus pregabalin in subjects with peripheral neuropathic pain: an open-label, randomized, multicenter, noninferiority efficacy and tolerability study
    Medical condition: Patients who have a documented diagnosis of probable or definite Peripheral Neuropathic Pain
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004852 10054095 Neuropathic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) FI (Completed) AT (Completed) SK (Completed) ES (Completed) BE (Completed) SI (Completed) GB (Completed) DE (Completed) GR (Completed) PT (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-000809-23 Sponsor Protocol Number: AB12003 Start Date*: 2014-10-10
    Sponsor Name:AB Science
    Full Title: A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo i...
    Medical condition: metastatic Castrate Resistant Prostate Cancer (mCRPC).
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Restarted) SK (Prohibited by CA) GR (Completed) CZ (Completed) GB (Temporarily Halted) IT (Suspended by CA)
    Trial results: (No results available)
    EudraCT Number: 2021-000639-30 Sponsor Protocol Number: AB20009 Start Date*: 2022-01-12
    Sponsor Name:AB Science
    Full Title: A 96-Weeks, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the T...
    Medical condition: Patients with primary progressive or secondary progressive multiple sclerosis without relapse
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063400 Secondary progressive multiple sclerosis PT
    21.1 10029205 - Nervous system disorders 10063401 Primary progressive multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) DE (Prematurely Ended) GR (Trial now transitioned) BG (Completed) NO (Prematurely Ended) PT (Ongoing) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-000491-14 Sponsor Protocol Number: AB12008 Start Date*: 2014-10-10
    Sponsor Name:AB Science
    Full Title: A prospective, multicentre, open-label, centrally allocated, active-controlled, phase 2 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alo...
    Medical condition: Advanced/metastatic epithelial ovarian cancer in second line being refractory to first line platinum treatment or in third line
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033158 Ovarian epithelial cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing) FR (Ongoing) GB (GB - no longer in EU/EEA) SK (Prohibited by CA) IT (Ongoing)
    Trial results: (No results available)
    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)
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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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