Not Yet RecruitingNot Applicable

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

30 participantsStarted 2024-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The age range of the subjects is from 18 to 65 years old, and there is no gender restriction for the subjects; * Male subjects weigh more than 50kg (including 50kg) and female subjects weigh more than 45kg (including 45kg); Body mass index \[BMI= weight (kg)/ height (m) 2\] is in the range of 19-26 kg/m 2, including the critical value; * The physical examination, laboratory examination, 12 lead electrocardiogram, chest X-ray (anterior lateral and lateral), and vital sign examination of the subjects are all within normal range or abnormal; * The subjects' blood routine, blood biochemistry, and urine routine are within the normal range; Exclusion Criteria: * People have a clinical history of the following diseases (including but not limited to gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, liver, bronchial, neurological, immune, lipid metabolism disorders, or known or suspected malignant tumors); * Patients who experience abnormal bleeding within the first 6 months of screening do not meet the criteria; * Pregnant and lactating women; Or female urine pregnancy test positive; * Blood routine, blood biochemistry, and urine routine examination are significantly abnormal; * Have a history of hospitalization or surgery within 6 months before screening; * Participate in other drug clinical studies within 3 months before screening; * Patients with a history of prescription drug abuse and illicit drug abuse or p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine the occurrence of type 1 hypersensitivity reaction

Timeframe: 20-30 minutes after injection

Determine the occurrence of type 4 hypersensitivity reaction

Timeframe: 48-72 hours after injection

Trial details

NCT IDNCT06574204

SponsorAffiliated Hospital of Nantong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

Contact for this trial

Yunzhao Xu

0086-13814606776 xuyz@ntu.edu.cn

View on ClinicalTrials.gov More Dermatitis, Allergic Contact trials