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

NCT06574204 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-08-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Affiliated Hospital of Nantong University

    lead OTHER

Principal Investigators

  • Yunzhao Xu · Affiliated Hospital of Nantong University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2024-12-31
Completion
2024-12-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574204 on ClinicalTrials.gov