NCT03443362

Brief Summary

Chronic urticaria (CU) is a disease that usually affects a large visible amount of surface of the skin. It is accompanied by severe itch and feeling of burned skin. Therefore the disease has a big impact on the quality of life of patients. Unfortunately, to date CU is not easily controlled by its few existing treatment options (i.e. antihistamines, omalizumab, cyclosporine). This research's main perspective is to improve quality of life for CU patients by first of all focusing on a good clinical diagnosis of (different subtypes of) CU in a CU reference center, and secondly by gaining more insight on the pathogenesis of the disease to expand knowledge on potential new targeted treatments for the patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

4.8 years

First QC Date

February 16, 2018

Last Update Submit

July 18, 2022

Conditions

Chronic Urticaria

Keywords

Chronic UrticariaEndothelial cells

Outcome Measures

Primary Outcomes (4)

  • Stem cell factor expression

    Immunohistochemistry performed on cryostat sections with a monoclonal antibody

    6 months

  • E-selectin expression

    Immunohistochemistry performed on paraformaldehyde fixed sections with a monoclonal antibody

    6 months

  • Vascular endothelial growth factor (VEGF) expression

    Immunohistochemistry performed with a monoclonal antibody on paraffin sections

    6 months

  • C5B9 complement complex expression

    Immunofluorescence staining performed on paraffin-embedded tissue blocks

    6 months

Secondary Outcomes (2)

  • Incidence of chronic inducible urticaria

    6 months

  • Incidence of chronic spontaneous urticaria

    6 months

Study Arms (2)

Chronic urticaria

50 consecutive chronic urticaria patients receiving medical care within the CHU Brugmann Hospital. Diagnose according to the European Academy of Allergy and Clinical Immunology (EAACI) guidelines.

Procedure: Punch BiopsyProcedure: Blood sampling

Control

20 healthy control patients, without chronic urticaria. Patients coming to the CHU Brugmann hospital for the excision of atypical naevi.

Procedure: Punch BiopsyProcedure: Blood sampling

Interventions

Punch BiopsyPROCEDURE

A 3 mm punch biopsy will be taken from lesional and non-lesional skin as a routine procedure.

Chronic urticariaControl
Blood samplingPROCEDURE

Blood sampling

Chronic urticariaControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with a diagnose of chronic urticaria receiving medical care within the CHU Brugmann Hospital. Diagnose performed according to the European Academy of Allergy and Clinical Immunology (EAACI) guidelines. The control group consists in patients beeing followed within the CHU Brugmann Hospital for the ellipsoid excision of atypical naevi on remnant healthy skin.

You may qualify if:

  • All patients diagnosed with chronic urticaria receiving medical care within the CHU Brugmann Hospital. Diagnose performed according to the European Academy of Allergy and Clinical Immunology (EAACI) guidelines.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

Related Publications (15)

  • Kaplan AP. Chronic urticaria: pathogenesis and treatment. J Allergy Clin Immunol. 2004 Sep;114(3):465-74; quiz 475. doi: 10.1016/j.jaci.2004.02.049.

    PMID: 15356542BACKGROUND

  • Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, Church MK, Ensina LF, Gimenez-Arnau A, Godse K, Goncalo M, Grattan C, Hebert J, Hide M, Kaplan A, Kapp A, Abdul Latiff AH, Mathelier-Fusade P, Metz M, Saini SS, Sanchez-Borges M, Schmid-Grendelmeier P, Simons FE, Staubach P, Sussman G, Toubi E, Vena GA, Wedi B, Zhu XJ, Nast A, Maurer M; Dermatology Section of the European Academy of Allergy and Clinical Immunology; Golbal Allergy and Asthma European Network; European Dermatology Forum; World Allergy Organization. Methods report on the development of the 2013 revision and update of the EAACI/GA2 LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2014 Jul;69(7):e1-29. doi: 10.1111/all.12370.

    PMID: 24898678BACKGROUND

  • Greaves M. Chronic urticaria. J Allergy Clin Immunol. 2000 Apr;105(4):664-72. doi: 10.1067/mai.2000.105706.

    PMID: 10756214BACKGROUND

  • Gaig P, Olona M, Munoz Lejarazu D, Caballero MT, Dominguez FJ, Echechipia S, Garcia Abujeta JL, Gonzalo MA, Lleonart R, Martinez Cocera C, Rodriguez A, Ferrer M. Epidemiology of urticaria in Spain. J Investig Allergol Clin Immunol. 2004;14(3):214-20.

    PMID: 15552715BACKGROUND

  • Hellgren L. The prevalence of urticaria in the total population. Acta Allergol. 1972;27(3):236-40. doi: 10.1111/j.1398-9995.1972.tb01420.x. No abstract available.

    PMID: 4678809BACKGROUND

  • Zuberbier T, Balke M, Worm M, Edenharter G, Maurer M. Epidemiology of urticaria: a representative cross-sectional population survey. Clin Exp Dermatol. 2010 Dec;35(8):869-73. doi: 10.1111/j.1365-2230.2010.03840.x.

    PMID: 20456386BACKGROUND

  • Sumpio BE, Riley JT, Dardik A. Cells in focus: endothelial cell. Int J Biochem Cell Biol. 2002 Dec;34(12):1508-12. doi: 10.1016/s1357-2725(02)00075-4.

    PMID: 12379270BACKGROUND

  • Constans J, Conri C. Circulating markers of endothelial function in cardiovascular disease. Clin Chim Acta. 2006 Jun;368(1-2):33-47. doi: 10.1016/j.cca.2005.12.030. Epub 2006 Mar 10.

    PMID: 16530177BACKGROUND

  • Coleman JW, Holliday MR, Kimber I, Zsebo KM, Galli SJ. Regulation of mouse peritoneal mast cell secretory function by stem cell factor, IL-3 or IL-4. J Immunol. 1993 Jan 15;150(2):556-62.

    PMID: 7678275BACKGROUND

  • Asero R, Tedeschi A, Lorini M, Gerosa M, Meroni P, Riboldi P. Circulating stem cell factor in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2003 Jul;91(1):79-81. doi: 10.1016/S1081-1206(10)62063-7.

    PMID: 12877454BACKGROUND

  • Kuwana M, Okazaki Y. Quantification of circulating endothelial progenitor cells in systemic sclerosis: a direct comparison of protocols. Ann Rheum Dis. 2012 Apr;71(4):617-20. doi: 10.1136/annrheumdis-2011-200713. Epub 2012 Jan 17.

    PMID: 22258488BACKGROUND

  • Yang Z, Wang JM, Chen L, Luo CF, Tang AL, Tao J. Acute exercise-induced nitric oxide production contributes to upregulation of circulating endothelial progenitor cells in healthy subjects. J Hum Hypertens. 2007 Jun;21(6):452-60. doi: 10.1038/sj.jhh.1002171. Epub 2007 Mar 15.

    PMID: 17344910BACKGROUND

  • Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available.

    PMID: 11581152BACKGROUND

  • Cutolo M, Sulli A, Pizzorni C, Smith V. Capillaroscopy as an Outcome Measure for Clinical Trials on the Peripheral Vasculopathy in SSc-Is It Useful? Int J Rheumatol. 2010;2010:784947. doi: 10.1155/2010/784947. Epub 2010 Aug 16.

    PMID: 20827384BACKGROUND

  • Mostmans Y, De Smedt K, Feoli F, Waelput W, De Maertelaer V, Olemans C, Meiers I, Cielen T, Corazza F, Michel O, Richert B. Elevated cutaneous expression of stem cell factor in chronic spontaneous urticaria: a prospective cohort study. Clin Exp Dermatol. 2024 Nov 22;49(12):1659-1667. doi: 10.1093/ced/llae252.

    PMID: 38963799DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin specimens (3 mm punch biopsy)

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Yora Mostmans, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yora Mostmans, MD

CONTACT

32 2 4772272Yora.MOSTMANS@chu-brugmann.be

Olivier Michel, MD

CONTACT

32 2 4773664Olivier.MICHEL@chu-brugmann.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 23, 2018

Study Start

February 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)