Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574204
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Caused by Macrolides
Sponsor:
None
Organization:
None
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:
No
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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None