NCT03163875

Brief Summary

Urticaria is one of the most frequent presenting complaints in dermatology, allergy, and emergency departments. The term chronic urticaria (CU) is understood as the appearance of recurrent wheals more than twice a week for over 6 consecutive weeks .Urticaria is not a single disease but a reaction pattern that represents cutaneous mast cell degranulation, resulting in extravasation of plasma into the dermis. The incidence of chronic urticaria is unknown, but it is thought to occur in 0.1%-3% of the population

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

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

First Submitted

Initial submission to the registry

May 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 15, 2017

Last Update Submit

May 25, 2017

Conditions

Keywords

erythemawheal formationvascular reaction of the skin

Outcome Measures

Primary Outcomes (1)

  • measure number of patients affected with depression and anxity

    The levels of depression and anxiety will be assessed by Hospital Anxiety Depression Scale (HADS) .

    one year

Interventions

To assess the levels of depression and anxiety, quality of sleep and quality of life (QoL) in chronic urticaria patients, using an interdisciplinary approach combining interview/questionnaire-based psychiatric and dermatological evaluations

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Antihistamines will be discontinued at least 72 h prior to evaluation.

You may qualify if:

  • Patients with chronic urticaria defined as a 6-week or longer history of daily or almost daily itchy cutaneous weals with individual lesions lasting less than 24 h.
  • Age between 18 and 60 years.

You may not qualify if:

  • Patients who are unable to understand the questions, are unwilling to complete the questionnaire, or who have a psychiatric disorder, or obstructive sleep apnea.
  • Patients with malignant or central nervous system disease. Patients with cognitive impairment due to a current cerebral or psychotic illness.
  • Patients with current psychotherapy . glucocorticoids therapy in the last month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic UrticariaErythema

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 23, 2017

Study Start

June 1, 2017

Primary Completion

June 10, 2018

Study Completion

August 1, 2018

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share