MedDataX Logo

Optimal Concentration of Dermatophagoides Pteronyssinus (Dp) Allergen Extract for Skin Prick Test (SPT) of Thai Population

NCT ID: NCT01172613

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the appropriate concentration of diagnostic reagent of house dust mite (Dp) to be used in diagnostic allergy skin prick test among Thai population with allergic rhinitis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The current allergy diagnostic reagent of house dust mites marketed in the USA is at 10,000 AU/ml. This is based on the IDEAL50 concept put forth by Turkeltaub et al, almost 3 decades ago. Such concentration has been shown to give large degree of false positives even in the US population.

In Thailand, it was anecdotally observed that at such concentration, sizes of positive tests among atopic subjects were quite large and could lead to discomfort and a possible anaphylaxis in certain allergic individuals. Moreover, up to 40% of normal individuals could give positive reaction to this concentration.

It is therefore desirable to reexamine the appropriate concentration of diagnostic reagent of house dust mites among the Thai population and will be the main objective of this research.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Skin Prick Test

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

allergic rhinitis concentration of diagnostic reagent allergen extract, house dust mites (Dp) skin prick test nasal allergen provocation test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

healthy subjects no symptoms

No interventions assigned to this group

allergic rhinitis patient

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* clinical diagnosis of allergic rhinitis
* has skin prick test positive to standard Dp extract (wheal diameter 3 mm. or greater)
* not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)


* no underlying disease
* not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)

Exclusion Criteria

* has skin prick test positive to standard Dp extract with wheal diameter more than 10 mm.
* has chronic disease eg. HIV infection, neurological diseases, hypertension, cardiac diseases, pulmonary diseases, hepatobiliary diseases, renal diseases, endocrinological diseases, congenital malformation, malignancy
* if has asthma, uncontrolled asthma symptom or PEF \< 70%
* during pregnancy or lactation
* has chronic skin disease
* participate other project within 30 days
* has abnormal anatomy of the nose
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Professor Pakit Vichyanond, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Professor Pakit Vichyanond, MD

Role: CONTACT

Phone: 02-419-9465-6

Email: [email protected]

Parawee Prottasan, MD

Role: CONTACT

Phone: 02-419-5670, 5889

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Professor Pakit Vichyanond, MD

Role: primary

Parawee Prottasan, MD

Role: backup

Professor Pakit Vichyanond, MD

Role: primary

Parawee Prottasan, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

112/2553(EC3)

Identifier Type: -

Identifier Source: org_study_id