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Efficacy and safety of Basicol in inhibiting false positives in penicillin skin tests: a single-center, randomized, open, placebo-controlled clinical trial

Efficacy and safety of Basicol in inhibiting false positives in penicillin skin tests: a single-center, randomized, open, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099661
Enrollment
Unknown
Registered
2025-03-26
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Penicillin allergy

Interventions

Intervention group(Patchouli treated group):Patchouli alcohol solution
Control group (blank treated group):Blank solvent

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Preoperative patients who are in good health and need to use antibiotics; 2. Have never had a history of positive penicillin skin test results; 3. Patients with no contraindications to routine laboratory tests and examinations before surgery; 4. Patients who voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients 80 years old; 2. Forearm skin breakage, scarring or too dark color to affect the operation or judgment of skin test; 3. Those who have had an excessively rapid onset allergic reaction in the past 4 weeks; 4. High-risk groups of anaphylactic shock, such as poor asthma control, history of severe allergic reaction caused by low-dose allergens, etc.; 5. Dermatographism, skin mastocytosis, acute and chronic urticaria and other skin diseases; 6. Use of systemic antihistamines (diphenhydramine, cetirizine, loratadine) within one week before skin test; 7. Use of receptor antagonist ranitidine within 2 days before skin test; 8. Drugs such as ß receptor blockers and angiotensin-converting enzyme inhibitors (ACE inhibitors) may affect the treatment of immediate allergic reactions, and should be stopped for at least 24 hours before skin test, especially when there is a possibility of severe allergic reactions; 9. Those with severe organ damage; 10. Suffering from a mental illness; 11. Pregnant and lactating women; 12. The subject is participating in other clinical trials or has participated in other clinical trials within three months; 13. The subject is unable to comply with the follow-up or affect the scientific integrity of the study; 14. Other patients who are not suitable for enrollment as assessed by clinicians.

Design outcomes

Primary

MeasureTime frame
Penicillin skin test results;

Secondary

MeasureTime frame
Pain level after PST;

Countries

China

Contacts

Public ContactJianru Xiao

Shanghai Changzheng Hospital

jianruxiao83@163.com+86 137 0178 5283

Outcome results

None listed

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