NCT06574204

Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Caused by Macrolides

The Mechanism and Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Resulting From Macrolides

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Clinical side effects of macrolides in addition to the common gastrointestinal reactions, recently it has been found that the incidence of local reactions after injection is relatively high, such as pain and itching and local inflammation. Severe skin reactions include erythema multiforme, acute systemic eruption impetigo, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions with eosinophilia and systemic symptoms. The clinical study is a single-center, randomized, open, single-dose trial design. The clinical study plans to enroll 30 subjects to evaluate the incidence and severity of pain and pruritus after a single skin test in healthy subjects. A total of 30 subjects were randomly divided into 2 groups with 15 cases in each group. Erythromycin or azithromycin skin test will be performed on the left hand, and the same amount of normal saline will be injected into the right hand as the control. This clinical observation experiment helps improve the side effects and promotes upgrading macrolide antibiotics during clinical application.

Conditions

• Dermatitis, Allergic Contact

Interventions

Type	Name	Description
DRUG	Erythromycin	The researchers injected 30 units of erythromycin into the inner right wrist of the subjects, which is a liquid dosage form.
DRUG	Azithromycin	The researchers injected 30 units of azithromycin into the inner right wrist of the subjects, which is a liquid dosage form.
OTHER	physiological saline	The researchers injected 10-20 μl of physiological saline into the inner left wrist of the subjects, which is a liquid dosage form.

Timeline

• Start date: 2024-09-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-08-27
• Last updated: 2024-08-27