Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Caused by Macrolides
- Conditions
- Dermatitis, Allergic Contact
- Registration Number
- NCT06574204
- Lead Sponsor
- Affiliated Hospital of Nantong University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria:<br><br> - The age range of the subjects is from 18 to 65 years old, and there is no gender<br> restriction for the subjects;<br><br> - Male subjects weigh more than 50kg (including 50kg) and female subjects weigh more<br> than 45kg (including 45kg); Body mass index [BMI= weight (kg)/ height (m) 2] is in<br> the range of 19-26 kg/m 2, including the critical value;<br><br> - The physical examination, laboratory examination, 12 lead electrocardiogram, chest<br> X-ray (anterior lateral and lateral), and vital sign examination of the subjects are<br> all within normal range or abnormal;<br><br> - The subjects' blood routine, blood biochemistry, and urine routine are within the<br> normal range;<br><br>Exclusion Criteria:<br><br> - People have a clinical history of the following diseases (including but not limited<br> to gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematological,<br> psychiatric, renal, liver, bronchial, neurological, immune, lipid metabolism<br> disorders, or known or suspected malignant tumors);<br><br> - Patients who experience abnormal bleeding within the first 6 months of screening do<br> not meet the criteria;<br><br> - Pregnant and lactating women; Or female urine pregnancy test positive;<br><br> - Blood routine, blood biochemistry, and urine routine examination are significantly<br> abnormal;<br><br> - Have a history of hospitalization or surgery within 6 months before screening;<br><br> - Participate in other drug clinical studies within 3 months before screening;<br><br> - Patients with a history of prescription drug abuse and illicit drug abuse or<br> positive urine drug screening within 6 months before screening;<br><br> - A history of alcohol abuse in the 6 months before screening, that is, drinking more<br> than 14 units of alcohol per week (1 single drink =360 mL beer or 45 mL spirits with<br> 40% alcohol or 150 mL wine);<br><br> - During the six months before screening, individuals who smoke more than 10<br> cigarettes per day or test positive for nicotine in their urine;<br><br> - Within the 3 months before screening, individuals consumed more than 1 liter of<br> strong tea, coffee, and/or caffeinated beverages per day;<br><br> - Within 3 months before screening, the patient has a history of blood donation or<br> acute blood loss (= 400mL);<br><br> - Within 2 weeks before the screening, people use prescription drugs, over-the-counter<br> drugs, traditional Chinese patent medicines, and simple preparations or Chinese<br> herbal medicines;<br><br> - People have a history of allergy to any of the components of the test drug<br> (erythromycin, azithromycin, other macrolides or ketolides);<br><br> - Any other factors deemed unsuitable for participation in this study by the<br> investigator.
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the occurrence of type 1 hypersensitivity reaction;Determine the occurrence of type 4 hypersensitivity reaction
- Secondary Outcome Measures
Name Time Method