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A clinical study for exploring the tolerance of performing multiple allergen skin prick tests simultaneously in Chinese volunteers

A clinical study for exploring the tolerance of performing multiple allergen skin prick tests simultaneously in Chinese volunteers

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023952
Enrollment
Unknown
Registered
2019-06-19
Start date
2019-06-25
Completion date
Unknown
Last updated
2019-06-26

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

Conditions

Allergic disease - allergen skin prick diagnosis

Interventions

Dose group 1:skin prick test-8 kinds of allergens
Dose group 2:skin prick test-8 kinds of allergens

Sponsors

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: All of the following criteria must be met in order to be selected as volunteers: 1) Gender: not limited, in which women must meet the following conditions: have been surgically sterilized; or have fertility, but the results of blood pregnancy (ß-HCG) before the enrollment are negative; 2) Aged 18 to 45 years (including the boundary value); 3) Those who have or are suffering from allergic diseases such as allergic rhinitis, allergic conjunctivitis, atopic dermatitis (inquiries); 4) Detection of Artemisia sIgE(w6)/Ordinary Birch sIgE(t3)/Ordinary ragweed sIgE(w1)/Sedge sIgE(w22)/Two-ball sycamore sIgE(t11)/German cockroach with UniCAP from Phadia, Sweden sIgE(i6)/cat dander sIgE(e1)/dog dander sIgE(e5), wherein the concentration of sIgE of at least two allergens should be between 0.70 and 100 KUA/L (including the boundary value); 5) Volunteers have the ability to understand and voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: Volunteers who meet one or more of the following criteria will be excluded: 1) Have orthostatic hypotension or have a history of fainting, or dizziness, or can not tolerate pricking, or symptoms of angioedema, or have a contraceptive conditions for adrenaline; 2) Pregnant or lactating women; 3) Those who have had severe allergic reactions or anaphylactic shock; 4) Those with a history of asthma or who are in an asthma attack; 5) Those who used antihistamines within 7 days before the prick test; 6) Those who have used phenothiazines or imipramine antidepressants within 30 days prior to the trial, or who are being treated with beta blockers or angiotensin converting enzyme (ACE) inhibitors; 7) Those who have undergone UV phototherapy within 30 days before the test; 8) Those who used topical glucocorticoids on the forearm within 2 days before the test; 9) Those with skin scratches; 10) Both forearms have skin infections, dermatitis or trauma, scars and other pathological changes or tattoos; 11) More than 20 cigarettes per day during the first 3 months of the trial; 12) Those who regularly drink alcohol within 6 months before the test, that is, drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); 13) Those with a history of drug abuse or urine screening (morphine, methamphetamine, ketamine, methylene dioxyamphetamine, tetrahydrocannabinol); 14) Those with severe liver and kidney disease, a history of cardiovascular and cerebrovascular diseases, a history of malignant diseases, and autoimmune diseases that affect the general condition; 15) Vital signs or physical examination, electrocardiogram, laboratory test indicators are abnormal and the investigator judges that there is clinical significance (except for those who have no effect on puncture or abnormalities caused by allergic diseases); 16) Those who have participated in other clinical trials within 3 months before the trial or who have lost blood more than 400 mL; 17) The investigator believes that there are any other people who are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
SPT positive symptoms;

Countries

China

Contacts

Public ContactGuoping Yang

The Third Xiangya Hospital of Central South University

ygp9880@162.com+86 5307311219

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026