Chemokine Expression in Nummular Dermatitis and Atopic De... | NCT01311986

Studies
Chemokine Expression in Nummular Dermatitis and Atopic Dermatitis

NCT01311986

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Apr 22, 2011Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Atopic Dermatitis
Nummular Eczema

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Oct 2011Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Mar 8, 2011

First Submission Date that Met QC Criteria

Mar 9, 2011

First Posted Date

Mar 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2011

Last Update Posted Date

Apr 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to measure the serum levels of CCL17, CCL18, CCL22 and CXCL10 and their expression levels in epidermis in AD and ND patients.

Detailed Description

Atopic dermatitis(AD) is a common cutaneous inflammatory disease. The pathogenesis of atopic dermatitis involves a complex interaction between atopy and environmental protein allergens which produces Th2 immune responses with IgE formation, Th2 cells dominate in lesions of atopic dermatitis, whereas Th1 and Th2 cells co-dominate in late eczematus lesions.

Nummular dermatitis(ND) is another common cutaneous inflammatory disease. The nummular patches and papules disseminated over four extremities and less over trunk . The serum levels of Th2 chemokines(CCL17, CCL22, CCL27) are elevated in AD patients. The expression levels of these chemokines in lesional epidermis are also increased. CCL18 which is derived from APC is also increased in the serum as well as lesional skin of AD patients. In contrast, there are very few reports regarding the chemokine expression profiles in ND patients. Because erosis is a remarkable exacerbating factor for ND. The investigators hypothesize that ND is a specialized contact dermatitis induced by environmental substances. It has been known, CCL17 and CXCL10 were highly expressed in lesion of allergic contant dermatitis, whereas almost no expression of these chemokines could be detected in lesions of irritant contact dermatitis.

The aim of this study is to measure the serum levels of CCL17, CCL18, CCL22 and CXCL10 and their expression levels in epidermis in AD and ND patients. The investigators hope that the results of this study will provide useful information for clinical differential diagnosis for AD and ND as well as understanding the pathogenesis of ND.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age:20~40, atopic dermatitis, BSA>10%, no asthma
age:20~40, nummular patches>10, no atopy

Exclusion Criteria:

systemic immunosuppresive agents within 4 weeks
high dose topical immunosuppresive agents within 4 weeks

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

patients with atopic dermatitis

patients with nummular eczema without atopy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hsien-Ching Chiu, MD	Department of Dermatology, National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei	Taipei	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Patients with atopic dermatitis
Patients with nummular eczema
Normal control