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Atopic DermatitisNCT04154839

Epidemiological Survey and Genetic Analysis of AD Patients in Hong Kong

An observational study of Atopic Dermatitis and Genetic Skin Disease, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a joint research study between The Hong Kong Polytechnic University (PolyU) and The University of Hong Kong (HKU) as titled above. In view of the increasing prevalence of atopic dermatitis (AD), the lack of complete epidemiology data on childhood and adult AD in Hong Kong and the lack of complete understanding… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis, Genetic Skin Disease, Eczema
How many people
450 participants
Where
1 siteHong Kong
Study dates
12 Jul 2019to 30 Jun 2022
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: For AD cases: Chinese-Han AD subjects who was born in Hong Kong For Control: Chinese-Han subjects who was born in Hong Kong aged more or equal to 40 Years

Who may be able to join

  • Normal controls (Recruited in Poly U)
  • Aged more or equal to 40 [Age of 40 is chosen as an arbitrary cutoff because studies had shown that the peak incidence among adult-onset AD cases occurs at age 20-40 years (Silvestre Salvador et al., 2017). Controls have been chosen more or equal to 40 years of age as they would likely have developed AD by the age of 40.
  • Subjects that do not have a history of AD, personal history and family history of AD including first-, second-, and third-degree relatives;
  • Subjects without a personal history and/or family history of other allergic and atopic disorders such as autoimmune diseases, skin disorders and systemic diseases.
  • Born in Hong Kong and Chinese-Han
  • AD cases (Recruited from QMH and TWH)
Show all 9Show fewer
  • Patients have to be clinically diagnosed by a qualified dermatologist on the basis of a skin examination diagnosed according to Hanifin and Rajka criteria.
  • Children cases should be aged < 18 at the time of recruitment and adult cases should be aged 18 at the time of recruitment;
  • Born in Hong Kong and Chinese-Han

Who cannot join

  • Non-Chinese or non-local case and control subjects;
  • Either of the parents are non-Chinese;
  • Case and control subjects who do not speak or understand Cantonese or Chinese;
  • Age <40 for control subjects;
  • Subjects who are pregnant;
  • Unable to provide signed informed consent.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Department of Medicine

    Central

Other trials in Hong Kong

About this study

Official title: Pilot Study: Epidemiological Survey and Genetic Analysis of Patients With Atopic Dermatitis in Hong Kong

This is a joint research study between The Hong Kong Polytechnic University (PolyU) and The University of Hong Kong (HKU) as titled above. In view of the increasing prevalence of atopic dermatitis (AD), the lack of complete epidemiology data on childhood and adult AD in Hong Kong and the lack of complete understanding on the genetic and environmental factors associated with it, the purpose of this study to carry out an epidemiology and genetic study that targets AD patients within the local Hong Kong population.

The investigators will search for new AD-associated genetic variants that are related to the local population and believe that the genetic profiles that arise from this project will form an important basis for the future management and treatment of AD, such as disease-risk screening strategy and therapeutic target development.

Read the detailed description

Atopic dermatitis (AD), atopic eczema or eczema, is a very common, highly pruritic chronic inflammatory skin disorder. The intense itching, sleep disturbance, coupled with visible rashes, causes immense physical, psychological, economical and social implications. Not only does it impact on the quality of life of the patient, caregivers are also often affected. AD can manifest during childhood, adolescence or adulthood. Those with childhood-onset AD can go into remission during puberty and adolescence, or persist into adulthood. The natural course of AD is generally intermittent and seasonal, with phases of latency and exacerbation. AD is a heterogeneous condition with typical manifestations of other allergic disorders, but clinically, AD is defined as a single disorder. It is impossible to propose a definitive gold standard for the diagnosis of AD due to its heterogeneity. The most widely used diagnostic criteria is the Hanifin and Rajka criteria with reported sensitivity and specificity of 87.9-96.0% and 77.6-93.8% respectively.

SCORAD (SCORing Atopic Dermatitis) is one of the common clinical tools for assessing the extent and severity of AD. However, the molecular pathogenesis behind AD is still not fully understood, and the condition is not yet curable. The prevalence of AD is on the rise worldwide especially among industrialized countries, with an overall prevalence of around 15-30% among children and 0.3-14% among adults. In China, the overall prevalence of childhood/adolescent onset AD and adult onset AD are estimated at around 3.1% and 4.6% respectively. Variability in the overall prevalence is most likely due to non-standardized diagnostic criteria applied across various studies, originally designed only for childhood-onset AD. In Hong Kong, the epidemiological data on AD is incomplete and only childhood-onset AD was studied. Given that a significant proportion of AD patients belong to the adult-onset group, it is important to determine accurately the epidemiology of both childhood-onset and adult-onset AD groups in Hong Kong.

Recent evidence has also suggested that AD as a whole is attributed to a mixture of environmental and genetic factors, as AD has been shown to cluster in families and demonstrate high concordance in monozygotic twins. Various research studies have been conducted to identify environmental risk factors worldwide. In Hong Kong, Hon et al. from the Department of Pediatrics at The Chinese University, conducted a cohort study following up 82 children with AD for 10 years, and found that risk factors are often related to urbanization and exposure to aeroallergens. However, it is unclear whether both genetic predisposition and environmental factors also play a role in adult-onset AD group.

Apart from environmental factors, researchers have used different methods, such as genome-wide association study (GWAS), to search for genetic variations associated with childhood-onset AD. Several large-scale GWAS and candidate gene studies have been conducted on children-onset AD around the world to search for genetic risk factors using single nucleotide polymorphisms (SNPs). In China, Sun et al. performed the first GWAS in China in 2011 among 1012 children cases and 1362 adult controls of Southern Chinese to search for common genetic variants using Illumina Human 610-Quad Beadchips, followed by three replication studies among Northern Chinese, Southern Chinese and German cases and controls using MassArray and TaqMan assay. Although no robustly replicated SNPs have been identified across all GWAS and candidate gene studies, the commonest associated genetic variants, are related to the different loss-of-function mutations that encodes for the filaggrin (FLG). Filaggrin is a filament-aggregating protein that binds keratin fibers in epithelial cells. The loss-of-function mutations in FLG leads to enhanced transepidermal water loss, ichthyosis, penetration of foreign antigens, and subsequent sensitization . Other genetic variants, related to defective immune pathway and impaired skin barrier function have also been suggested in the past as risk factors for pathogenesis of AD. Despite this, there is currently no published data comparing genetic variants between adult-onset and children-onset AD groups. In addition, GWAS study in AD patients has not been conducted in Hong Kong.

The study will be conducted in compliance with local Institutional Review Board (IRB) and Good Clinical Practice (GCP).

Keywords
Atopic dermatitis, Genetics, Eczema, Epidemiology
Medical subject headings
Dermatitis, Atopic, Skin Diseases, Genetic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04154839
Study groupRoleWhat they receive
Atopic dermatitis groupNumber of subjects in atopic dermatitis group 0 - < 6 years : 50 subjects 6 - <12 years : 50 subjects 12 - <18 years : 50 subjects Adult (>= 18 years) : 150 subjects Total no. of cases: 300 cases
Control group>= 40 yrs : 150 subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Significant SNPs

    The significant single nucleotide polymorphisms (SNPs) between control group and different AD case subgroups (different age of onset, different AD severity, different relapsing status), Cochran-Armitage trend test will be used to assess statistical significance of the association with each SNP, and Mantel-Haenszel method for two 2 × 2 allele frequency tables will be used to assess association of SNPs on chromosome X within male and female subjects.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study start12 Jul 2019
  3. Primary completion31 Dec 2021
  4. Study completion30 Jun 2022 (estimated)

Resources

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
Prospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04154839
Sponsor's protocol ID
UW 19-417
Status last verified
May 2022
First submitted
29 Oct 2019
Last updated
5 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share individual participant data

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis and Genetic Skin Disease, run by The University of Hong Kong at 1 site in Hong Kong.

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 9 inclusion and 6 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 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Significant SNPs (time frame: through study completion, an average of 1 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 5 May 2022.

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