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CompletedNCT01284426NHCUUpdated Feb 1, 2016Results posted

Natural History of Chronic Urticaria

An observational study in Chronic Urticaria, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 4 Years to 15 Years. Per ClinicalTrials.gov, last updated 2016-02-01.

Sponsored by Mahidol University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
94
Ages
4 Years to 15 Years
Sex
All
01

Study summary

The purpose of this study is to examine the natural history of chronic urticaria in children and to identify the predictors for chronic urticaria remission.

Read the detailed description

A Prospective cohort study of 92 children who were diagnosed with chronic urticaria to investigate the natural course of chronic urticaria and to identify predictors of disease remission.

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Conditions studied

  • Chronic Urticaria

Keywords

  • Chronic urticaria
  • Natural course
  • Remission
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In context

Urticaria

237 studies on the registry are indexed under Urticaria; 26 are open to participants now.

This study's enrollment of 94 is below the median of 162 across 52 observational studies indexed under Urticaria.

Browse Urticaria studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric allergy clinic, Siriraj Hospital Mahidol University, Thailand, Children 4-15 years of age with chronic urticaria.

Inclusion criteria

  • Children 4-15 years of age with the diagnosis of chronic urticaria who were attending the pediatric allergy clinic, Siriraj Hospital Mahidol University, Thailand, from March 2003 to March 2009.

Exclusion criteria

Exclusion Criteria:

  • Children who had isolated physical urticaria, inability to be followed up, pregnancy, underlying diseases such as cardiovascular, hepatobiliary, and renal diseases.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
94 participants (actual)

Groups and cohorts

  • Chronic urticaria

    Chronic urticaria, Natural history

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What researchers measure

Primary outcomes

  1. Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed.

    Remission rates at 1, 3 and 5 years after the onset of symptoms of chronic urticaria. Description in details: Actually, this study have been started in March 2003 and finally done in March 2009, which would be totally 6 years. We eventually decided to report the rate of CU remissions only at 1, 3 and 5 years after the onset of symptoms because this would be the common interval time of CU symptoms that patients needed to know how long they should have those CU symptoms or how many of them would go away their symptoms within 1, 3 or 5 years. Another reason is that the remission rate of CU between 5 and 6 years was not significantly different, so it might not need to be reported.

    Time frame: 6 years

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Results

Posted Feb 1, 2016
Limitations and caveats
This study did not perform basophil histamine releasing assay to identify the existence of functional autoantibodies, since there was no available laboratory to do this test.

Participant flow

Participant flow — Overall Study
MilestoneChronic Urticaria
Started94
Completed92
Not completed2

Outcome measures

PrimaryDuration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed.

Remission rates at 1, 3 and 5 years after the onset of symptoms of chronic urticaria. Description in details: Actually, this study have been started in March 2003 and finally done in March 2009, which would be totally 6 years. We eventually decided to report the rate of CU remissions only at 1, 3 and 5 years after the onset of symptoms because this would be the common interval time of CU symptoms that patients needed to know how long they should have those CU symptoms or how many of them would go away their symptoms within 1, 3 or 5 years. Another reason is that the remission rate of CU between 5 and 6 years was not significantly different, so it might not need to be reported.

Time frame:
6 years
Reported as:
Number · percentage of participants
Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed.
percentage of participantsChronic Urticaria
Remission rate at 1 year after the onset18.5
Remission rate at 3 year after the onset54
Remission rate at 5 year after the onset67.7

Adverse events

Collected over 6 years. Actually, this study is the prospective observational study of chronic urticaria for over 6 years regarding only the remission of the disease.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chronic Urticaria—0/92 (0%)62/92 (67.4%)
Most frequent other events
Most frequent other events
EventChronic Urticaria
Remission of chronic urticaria (CU) after 5 years of symptomsSkin and subcutaneous tissue disorders62/92
Remission of chronic urticaria after 3 years of symptomsSkin and subcutaneous tissue disorders50/92
Remission of chronic urticaria after 1 year of symptomsSkin and subcutaneous tissue disorders17/92

Baseline characteristics

Remission period, chronic urticaria

Age, Continuous
Age, Continuous(Years)Chronic Urticaria
Median8.4 (4.0 to 15.5)
Sex: Female, Male
Sex: Female, Male(Participants)Chronic Urticaria
Female49
Male43
Region of Enrollment
Region of Enrollment(participants)Chronic Urticaria
Thailand92
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Study locations

1 site
  • Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
09

References and documents

Publications

  • Chansakulporn S, Pongpreuksa S, Sangacharoenkit P, Pacharn P, Visitsunthorn N, Vichyanond P, Jirapongsananuruk O. The natural history of chronic urticaria in childhood: a prospective study. J Am Acad Dermatol. 2014 Oct;71(4):663-8. doi: 10.1016/j.jaad.2014.05.069. Epub 2014 Jul 11. PubMed 25023899 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01284426
Lead sponsor
Mahidol University
Responsible party
Orathai Piboonpocanun (Prof., Mahidol University) — Principal investigator
First posted
Jan 27, 2011
Start date
Mar 2003
Primary completion
Mar 2009
Completion
Mar 2009
Results posted
Feb 1, 2016
Last update
Feb 1, 2016

Study contacts

Orathai Piboonpocanun, Prof.
principal investigator · Siriraj Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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