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

Optimal Concentration of Allergen Extract of Dermatophagoides Pteronyssinus to be Used in Diagnostic Allergy Skin Prick Test Among Thai Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01172613
Acronym
DSPT
Enrollment
110
Registered
2010-07-30
Start date
2010-06-30
Completion date
Unknown
Last updated
2010-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief summary

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

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.

Interventions

None listed

Sponsors

Siriraj Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

allergic rhinitis * 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) Inclusion Criteria:healthy subject * 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

Design outcomes

Primary

MeasureTime frameDescription
appropriate concentration of diagnostic reagent of house dust mite (Dp)15 minutesto determine appropriate dilutional concentration of diagnostic reagent of house dust mite (Dp) that has high sensitivity and positive predictive value and wheal size not more than 10 mm. to be used in diagnosis allergic rhinitis in Thai population by skin prick test.

Secondary

MeasureTime frame
false positive rates of various dilutions of diagnostic reagent (house dust mite: Dp) that be used in skin prick test in Thai healthy population15 minutes
false negative rates of various dilutions of diagnostic reagent (house dust mite: Dp) that be used for diagnosis allergic rhinitis in Thai population by skin prick test15 minutes

Countries

Thailand

Contacts

Primary ContactProfessor Pakit Vichyanond, MD
pakitv@gmail.com02-419-9465-6
Backup ContactParawee Prottasan, MD
Parawee_p@hotmail.com02-419-5670, 5889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026