Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-31 @ 8:43 AM
Study NCT ID:
NCT06574204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-27
First Post:
2024-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Caused by Macrolides
Sponsor:
Affiliated Hospital of Nantong University
Organization:
Study Overview
Official Title:
The Mechanism and Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Resulting From Macrolides
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: