NCT02532920

Brief Summary

Atopic dermatitis(AD) is one of manifestation in atopic march. The prevalence of AD is increased. In 1998, the investigators found the prevalence of AD about 15 % in Thailand. AD is diagnosed by clinical as Hanifin and Rajka criteria. There are 3 group of severity defined by SCORAD(Scoring Atopic Dermatitis) : mild (\<25), moderate (25-50) and severe (\>50). The natural history of AD was mentioned in 3 groups: complete remission, persistent and intermittent. Atopic march is the progression of atopic disease that has atopic dermatitis as the first manifestation then patients will have allergic rhinitis or asthma in the future. The investigators do a retrospective study to understand the natural history of AD as well as it associate with atopic march. That might be a predictive factor of AD and atopic march

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

August 20, 2015

Last Update Submit

September 21, 2016

Conditions

Keywords

Natural historyAtopic dermatitisAtopic march

Outcome Measures

Primary Outcomes (1)

  • To evaluate the natural history of atopic dermatitis in Thai children and the factors that could be associate with the progression of the disease.

    complete remission (no AD rash and no topical steroid (TS) or topical tacrolimus (TT) use more than one year), persistent (use TS/TT once a month to control AD) and intermittent (other than two groups)

    Recruited the AD patient who was diagnosed between at birth until 15 years old. The following time at allergy clinic about 4 years in average.

Secondary Outcomes (1)

  • The association of atopic dermatitis and atopic march.

    At the first diagnosis of atopic dermatitis until current Allergic visit or telephone interview.The following time at allergy clinic about 4 years in average.

Study Arms (1)

Atopic dermatitis

Atopic dermatitis is diagnosis as Hanifin and Rajka from physician.

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patient who was diagnosed with atopic dermatitis by physician by searching ICD 10(L20.9, L20.8)

You may qualify if:

  • Diagnosis of AD by physician at birth-15 years old
  • Diagnosed by physician by Hanifin and Rajka criteria: itching, dry skin, chronic dermatitis : at face, extensor area (infant), flexor area (children and adult), with or with out history of atopy in family
  • Follow at allergy clinic once a year or can ask current symptom via telephone interview.
  • Evaluate severity of the disease by SCORAD (Scoring Atopic Dermatitis )

You may not qualify if:

  • Onset of atopic dermatitis more than 15 years old.
  • Other disease: skin, cardiovascular, liver disease, endocrine, neurology, ect
  • Not complete data collection in case record form in out patient record.
  • Cannot be reach current symptom of patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (8)

  • Nicol NH, Boguniewicz M, Strand M, Klinnert MD. Wet wrap therapy in children with moderate to severe atopic dermatitis in a multidisciplinary treatment program. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):400-6. doi: 10.1016/j.jaip.2014.04.009.

  • Odhiambo JA, Williams HC, Clayton TO, Robertson CF, Asher MI; ISAAC Phase Three Study Group. Global variations in prevalence of eczema symptoms in children from ISAAC Phase Three. J Allergy Clin Immunol. 2009 Dec;124(6):1251-8.e23. doi: 10.1016/j.jaci.2009.10.009.

  • Chung Y, Kwon JH, Kim J, Han Y, Lee SI, Ahn K. Retrospective analysis of the natural history of atopic dermatitis occurring in the first year of life in Korean children. J Korean Med Sci. 2012 Jul;27(7):723-8. doi: 10.3346/jkms.2012.27.7.723. Epub 2012 Jun 29.

  • Vichyanond P, Jirapongsananuruk O, Visitsuntorn N, Tuchinda M. Prevalence of asthma, rhinitis and eczema in children from the Bangkok area using the ISAAC (International Study for Asthma and Allergy in Children) questionnaires. J Med Assoc Thai. 1998 Mar;81(3):175-84.

  • Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.

  • Shaker M. New insights into the allergic march. Curr Opin Pediatr. 2014 Aug;26(4):516-20. doi: 10.1097/MOP.0000000000000120.

  • Illi S, von Mutius E, Lau S, Nickel R, Gruber C, Niggemann B, Wahn U; Multicenter Allergy Study Group. The natural course of atopic dermatitis from birth to age 7 years and the association with asthma. J Allergy Clin Immunol. 2004 May;113(5):925-31. doi: 10.1016/j.jaci.2004.01.778.

  • Wisniewski JA, Agrawal R, Minnicozzi S, Xin W, Patrie J, Heymann PW, Workman L, Platts-Mills TA, Song TW, Moloney M, Woodfolk JA. Sensitization to food and inhalant allergens in relation to age and wheeze among children with atopic dermatitis. Clin Exp Allergy. 2013 Oct;43(10):1160-70. doi: 10.1111/cea.12169.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Orathia Piboonpocanun, professor

    Siriraj Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Allergy and Immunology, Department of Pediatrics, Siriraj hospital

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 26, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 22, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations