Chronic UrticariaNCT03163875
Quality of Life in Patients With Chronic Urticaria
An observational study of Chronic Urticaria, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- Hospital Anxiety and Depression Scale
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Antihistamines will be discontinued at least 72 h prior to evaluation.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Quality of Life,Anxity,Depression and Quality of Sleep in Patients With Chronic Urticaria
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
Read the detailed description
Chronic urticaria signs and symptoms include: patches of red or white wheals, usually on the face, trunk, arms or legs. Wheals vary in size, change shape, and appear and fade repeatedly as the reaction runs its course. Itching is common, which may be severe. Swelling may occur that causes pain or burning (angioedema), especially inside the throat and around the eyes, cheeks, lips, hands, feet and genitals.
It is characterized by a tendency for signs and symptoms to flare with triggers such as heat, exercise and stress as well as a tendency for symptoms to recur frequently and unpredictably, sometimes for months or years The significance of chronic urticaria is sometimes trivialised because it is a non-life-threatening disease, but the condition can be very uncomfortable and interfere with sleep and daily activities. It is one of the most common and frustrating diseases for both patients and physicians Chronic urticaria has a major impact on quality of life (QoL) , with impact on activities of daily living. Chronic urticaria patients reportedly suffer considerable loss of energy, sleep disturbance and emotional upset as well as restrictions in the social life. Depression and anxiety are the most common psychiatric diagnoses. These psychiatric disorders could also influence QoL
- Conditions
- Chronic Urticaria
- Being tested
- Hospital Anxiety and Depression Scale
- Keywords
- erythema, wheal formation, vascular reaction of the skin
- Medical subject headings
- Chronic Urticaria, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Anxiety and Depression ScaleOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
measure number of patients affected with depression and anxity
The levels of depression and anxiety will be assessed by Hospital Anxiety Depression Scale (HADS) .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion10 Jun 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMAbdelgawad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163875
- Sponsor's protocol ID
- ziad
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life,Anxity,Depression and Quality of Sleep in Patients With Chronic Urticaria
- ClinicalTrials.gov ID
- NCT03163875
- Acronym / sponsor ID
- ziad
- Conditions
- Chronic Urticaria
- Keywords
- erythema, wheal formation, vascular reaction of the skin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 10 Jun 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Chronic urticaria signs and symptoms include: patches of red or white wheals, usually on the face, trunk, arms or legs. Wheals vary in size, change shape, and appear and fade repeatedly as the reaction runs its course. Itching is common, which may be severe. Swelling may occur that causes pain or burning (angioedema), especially inside the throat and around the eyes, cheeks, lips, hands, feet and genitals.
It is characterized by a tendency for signs and symptoms to flare with triggers such as heat, exercise and stress as well as a tendency for symptoms to recur frequently and unpredictably, sometimes for months or years The significance of chronic urticaria is sometimes trivialised because it is a non-life-threatening disease, but the condition can be very uncomfortable and interfere with sleep and daily activities. It is one of the most common and frustrating diseases for both patients and physicians Chronic urticaria has a major impact on quality of life (QoL) , with impact on activities of daily living. Chronic urticaria patients reportedly suffer considerable loss of energy, sleep disturbance and emotional upset as well as restrictions in the social life. Depression and anxiety are the most common psychiatric diagnoses. These psychiatric disorders could also influence QoL
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Antihistamines will be discontinued at least 72 h prior to evaluation.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital Anxiety and Depression ScaleTo 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 | Other | – |
Primary outcome
measure number of patients affected with depression and anxity
Time frame: one year
The levels of depression and anxiety will be assessed by Hospital Anxiety Depression Scale (HADS) .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Urticaria, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure number of patients affected with depression and anxity (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.