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A Clinical Study to Evaluate the Clinical Performance and Safety of the Skin Prick Test Reader

A Clinical Study to Evaluate the Clinical Performance and Safety of the Skin Prick Test Reader

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122820
Enrollment
Unknown
Registered
2026-04-19
Start date
2025-12-11
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Allergic diseases

Interventions

Control group:Skin prick test, manual interpretation of results
Experimental group:Skin prick test, reading results of skin allergen prick test by the instrument

Sponsors

Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 - 60 years old (inclusive of 18 and 60); Gender not restricted; 2. Has a history of allergic diseases or has allergic symptoms, and is assessed by the researcher to require allergen screening; 3. The subject is capable of understanding and voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The areas on the palmar side of the forearm where the prick test was conducted showed pathological changes such as skin infections, dermatitis, trauma, scars, and pigmentation. These were evaluated by the researchers to determine if they affected the identification of hives. 2. Those who had experienced severe allergic reactions in the past (including systemic urticaria, acute asthma attacks requiring emergency treatment or hospitalization, anaphylactic shock, etc.). 3. Those who had taken antihistamine drugs or compound preparations containing antihistamine drugs systemically before the prick test, and whose medication cessation period was less than 7 days. 4. Pregnant or lactating women. 5. Those who, after assessment by the researchers, were deemed to have any other conditions that were not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Positive agreement rate;Negative agreement rate;Overall agreement rate;Kappa value;Adverse event;

Countries

China

Contacts

Public ContactMang Xiao

Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine

joelxm@zju.edu.cn+86 572 835 1887

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026